Trial Outcomes & Findings for Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim2) (NCT NCT02127125)
NCT ID: NCT02127125
Last Updated: 2020-09-11
Results Overview
Insulin sensitivity in skeletal muscle (M value) as measured by hyperinsulinemic euglycemic clamp study. The clamp study tests the ability of peripheral tissues such as skeletal muscle to uptake glucose in response to a constant insulin stimulus, which give a measure of sensitivity to insulin action. 60 mU/m2\*min insulin was infused into subjects for 180 minutes with concomitant adjustment of glucose infusion rate using D20 glucose to maintain a clamped plasma glucose concentration of 100 mg/dL. When the glucose infusion rate equals the rate of glucose uptake and the targeted glucose concentration is achieved, the clamp is at steady-state equilibrium. Steady-state glucose infusion rate at 150min-180mins was used as the measure to calculate the M value.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
Change from baseline insulin sensitivity at 28 days of the intervention.
Results posted on
2020-09-11
Participant Flow
69 participants were screened, 8 were screen failures, so not randomized.
Participant milestones
| Measure |
Lean With NGT-Placebo
Lean (BMI\< 26 kg/m2) normal glucose tolerant Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
|
Lean With NGT-Sevelamer
Lean (BMI\< 26 kg/m2) normal glucose tolerant Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Lean With NGT-Synbiotic
Lean (BMI\< 26 kg/m2) normal glucose tolerant Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
Obese With NGT-Placebo
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks
|
Obese With NGT-Sevelamer
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Obese With NGT-Synbiotic
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
Type 2 Diabetes -Placebo
Type 2 Diabetics Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
|
Type 2 Diabetes-Sevelamer
Type 2 Diabetics Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Type 2 Diabetes-Synbiotic
Type 2 Diabetics Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
9
|
11
|
12
|
12
|
2
|
0
|
1
|
|
Overall Study
COMPLETED
|
6
|
8
|
8
|
10
|
9
|
9
|
2
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
3
|
3
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lean With NGT-Placebo
Lean (BMI\< 26 kg/m2) normal glucose tolerant Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
|
Lean With NGT-Sevelamer
Lean (BMI\< 26 kg/m2) normal glucose tolerant Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Lean With NGT-Synbiotic
Lean (BMI\< 26 kg/m2) normal glucose tolerant Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
Obese With NGT-Placebo
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks
|
Obese With NGT-Sevelamer
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Obese With NGT-Synbiotic
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
Type 2 Diabetes -Placebo
Type 2 Diabetics Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
|
Type 2 Diabetes-Sevelamer
Type 2 Diabetics Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Type 2 Diabetes-Synbiotic
Type 2 Diabetics Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
1
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim2)
Baseline characteristics by cohort
| Measure |
Lean With NGT-Placebo
n=6 Participants
Lean (BMI\< 26 kg/m2) normal glucose tolerant Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
|
Lean With NGT-Sevelamer
n=8 Participants
Lean (BMI\< 26 kg/m2) normal glucose tolerant Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Lean With NGT-Synbiotic
n=8 Participants
Lean (BMI\< 26 kg/m2) normal glucose tolerant Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
Obese With NGT-Placebo
n=10 Participants
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
|
Obese With NGT-Sevelamer
n=9 Participants
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Obese With NGT-Synbiotic
n=9 Participants
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
Type 2 Diabetes-Placebo
n=2 Participants
Type 2 Diabetics Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
|
Type 2 Diabetes-Sevelamer
Type 2 Diabetics Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Type 2 Diabetes-Synbiotic
n=1 Participants
Type 2 Diabetics Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
51 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
46.9 years
STANDARD_DEVIATION 15.7 • n=7 Participants
|
48.8 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
51.7 years
STANDARD_DEVIATION 12.4 • n=21 Participants
|
50.3 years
STANDARD_DEVIATION 8.4 • n=8 Participants
|
61.0 years
STANDARD_DEVIATION 1.4 • n=8 Participants
|
—
|
52.0 years
STANDARD_DEVIATION 0.0 • n=42 Participants
|
49.2 years
STANDARD_DEVIATION 12.1 • n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
37 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
10 participants
n=4 Participants
|
9 participants
n=21 Participants
|
9 participants
n=8 Participants
|
2 participants
n=8 Participants
|
—
|
1 participants
n=42 Participants
|
53 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Change from baseline insulin sensitivity at 28 days of the intervention.Population: Enrollment and completion for Type 2 diabetes mellitus group was low due to exclusionary criteria that prevented most diabetes medications from being used while in the study. Lean with NGT and Obese with NGT groups completed 6 control, 8 sevelamer, 8 synbiotic subjects for Lean group and 10 control, 9 sevelamer and 9 synbiotic for Obese group.
Insulin sensitivity in skeletal muscle (M value) as measured by hyperinsulinemic euglycemic clamp study. The clamp study tests the ability of peripheral tissues such as skeletal muscle to uptake glucose in response to a constant insulin stimulus, which give a measure of sensitivity to insulin action. 60 mU/m2\*min insulin was infused into subjects for 180 minutes with concomitant adjustment of glucose infusion rate using D20 glucose to maintain a clamped plasma glucose concentration of 100 mg/dL. When the glucose infusion rate equals the rate of glucose uptake and the targeted glucose concentration is achieved, the clamp is at steady-state equilibrium. Steady-state glucose infusion rate at 150min-180mins was used as the measure to calculate the M value.
Outcome measures
| Measure |
Obese With NGT-Placebo
n=10 Participants
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
|
Lean With NGT-Placebo
n=6 Participants
Lean (BMI\< 26 kg/m2) normal glucose tolerant Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks
|
Lean With NGT-Sevelamer
n=8 Participants
Lean (BMI\< 26 kg/m2) normal glucose tolerant Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Lean With NGT-Synbiotic
n=8 Participants
Lean (BMI\< 26 kg/m2) normal glucose tolerant Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
Obese With NGT-Sevelamer
n=9 Participants
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Obese With NGT-Synbiotic
n=9 Participants
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
Type 2 Diabetes-Placebo
n=2 Participants
Type 2 Diabetics Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
|
Type 2 Diabetes-Sevelamer
Type 2 Diabetics Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Type 2 Diabetes-Synbiotic
n=1 Participants
Type 2 Diabetics Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Insulin Sensitivity
|
5.96 M Value (mg/kg/min)
Standard Deviation 2.24
|
10.16 M Value (mg/kg/min)
Standard Deviation 3.78
|
8.45 M Value (mg/kg/min)
Standard Deviation 2.25
|
9.47 M Value (mg/kg/min)
Standard Deviation 2.59
|
8.14 M Value (mg/kg/min)
Standard Deviation 2.138
|
5.45 M Value (mg/kg/min)
Standard Deviation 1.88
|
3.81 M Value (mg/kg/min)
Standard Deviation .386
|
—
|
1.42 M Value (mg/kg/min)
|
SECONDARY outcome
Timeframe: Change from baseline plasma endotoxin level and its panel during 28 days.Population: Poor recruitment for type 2 diabetic group means few subjects analyzed.
Plasma Lipopolysaccharide (LPS) after intervention period
Outcome measures
| Measure |
Obese With NGT-Placebo
n=10 Participants
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
|
Lean With NGT-Placebo
n=6 Participants
Lean (BMI\< 26 kg/m2) normal glucose tolerant Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks
|
Lean With NGT-Sevelamer
n=8 Participants
Lean (BMI\< 26 kg/m2) normal glucose tolerant Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Lean With NGT-Synbiotic
n=8 Participants
Lean (BMI\< 26 kg/m2) normal glucose tolerant Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
Obese With NGT-Sevelamer
n=8 Participants
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Obese With NGT-Synbiotic
n=9 Participants
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
Type 2 Diabetes-Placebo
n=1 Participants
Type 2 Diabetics Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
|
Type 2 Diabetes-Sevelamer
Type 2 Diabetics Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Type 2 Diabetes-Synbiotic
n=1 Participants
Type 2 Diabetics Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Plasma Endotoxin Level and Its Panel.
|
0.6230 Endotoxin units/mL
Standard Deviation 0.1976
|
0.4452 Endotoxin units/mL
Standard Deviation 0.1987
|
0.5634 Endotoxin units/mL
Standard Deviation 0.1713
|
0.6925 Endotoxin units/mL
Standard Deviation 0.5907
|
0.8012 Endotoxin units/mL
Standard Deviation 0.4187
|
0.7195 Endotoxin units/mL
Standard Deviation 0.2905
|
0.2961 Endotoxin units/mL
|
—
|
0.4062 Endotoxin units/mL
|
SECONDARY outcome
Timeframe: Change from baseline gut permeability at 24 days of the intervention.Population: One obese sevelamer subject was not able to complete their baseline Lactulose: Mannitol ratio assay, thus cannot evaluate pre-post effect from their study.
urine lactulose: mannitol ratio.
Outcome measures
| Measure |
Obese With NGT-Placebo
n=10 Participants
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
|
Lean With NGT-Placebo
n=6 Participants
Lean (BMI\< 26 kg/m2) normal glucose tolerant Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks
|
Lean With NGT-Sevelamer
n=8 Participants
Lean (BMI\< 26 kg/m2) normal glucose tolerant Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Lean With NGT-Synbiotic
n=8 Participants
Lean (BMI\< 26 kg/m2) normal glucose tolerant Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
Obese With NGT-Sevelamer
n=8 Participants
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Obese With NGT-Synbiotic
n=9 Participants
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
Type 2 Diabetes-Placebo
n=2 Participants
Type 2 Diabetics Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
|
Type 2 Diabetes-Sevelamer
Type 2 Diabetics Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Type 2 Diabetes-Synbiotic
n=1 Participants
Type 2 Diabetics Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gut Permeability
|
0.02055 ratio
Standard Deviation 0.01018
|
0.02262 ratio
Standard Deviation 0.006856
|
0.02164 ratio
Standard Deviation 0.008943
|
0.02349 ratio
Standard Deviation 0.008680
|
0.01635 ratio
Standard Deviation 0.006882
|
0.01952 ratio
Standard Deviation 0.004869
|
0.02662 ratio
Standard Deviation 0.004186
|
—
|
0.01979 ratio
|
Adverse Events
Lean With NGT-Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Lean With NGT-Sevelamer
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Lean With NGT-Synbiotic
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Obese With NGT-Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Obese With NGT-Sevelamer
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Obese With NGT-Synbiotic
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Type 2 Diabetes-Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Type 2 Diabetes-Sevelamer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Type 2 Diabetes-Synbiotic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lean With NGT-Placebo
n=6 participants at risk
Lean (BMI\< 26 kg/m2) normal glucose tolerant Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks
|
Lean With NGT-Sevelamer
n=8 participants at risk
Lean (BMI\< 26 kg/m2) normal glucose tolerant Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Lean With NGT-Synbiotic
n=8 participants at risk
Lean (BMI\< 26 kg/m2) normal glucose tolerant Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
Obese With NGT-Placebo
n=10 participants at risk
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
|
Obese With NGT-Sevelamer
n=9 participants at risk
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Obese With NGT-Synbiotic
n=9 participants at risk
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
Type 2 Diabetes-Placebo
n=2 participants at risk
Type 2 Diabetics Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
|
Type 2 Diabetes-Sevelamer
Type 2 Diabetics Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
|
Type 2 Diabetes-Synbiotic
n=1 participants at risk
Type 2 Diabetics Synbiotic \[5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/8 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/8 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
20.0%
2/10 • Number of events 2 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/9 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/9 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/2 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
—
0/0 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
12.5%
1/8 • Number of events 1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
12.5%
1/8 • Number of events 1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/10 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
11.1%
1/9 • Number of events 1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/9 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/2 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
—
0/0 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
12.5%
1/8 • Number of events 1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/8 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
10.0%
1/10 • Number of events 1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/9 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/9 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/2 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
—
0/0 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
|
Gastrointestinal disorders
Abdominal Bloating/Flatulence
|
0.00%
0/6 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/8 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
12.5%
1/8 • Number of events 1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
20.0%
2/10 • Number of events 2 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
11.1%
1/9 • Number of events 1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
11.1%
1/9 • Number of events 1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/2 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
—
0/0 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
|
Nervous system disorders
Headache/Lightheadedness
|
33.3%
2/6 • Number of events 2 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/8 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/8 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
10.0%
1/10 • Number of events 1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/9 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
11.1%
1/9 • Number of events 1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/2 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
—
0/0 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
|
Surgical and medical procedures
Biopsy Site Pain/soreness
|
16.7%
1/6 • Number of events 1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
12.5%
1/8 • Number of events 2 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
37.5%
3/8 • Number of events 3 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
30.0%
3/10 • Number of events 4 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
11.1%
1/9 • Number of events 1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
22.2%
2/9 • Number of events 2 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
50.0%
1/2 • Number of events 1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
—
0/0 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia Exacerbation
|
0.00%
0/6 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/8 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/8 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/10 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
11.1%
1/9 • Number of events 1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/9 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/2 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
—
0/0 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
|
Blood and lymphatic system disorders
Intermittent edema
|
0.00%
0/6 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/8 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/8 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/10 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
11.1%
1/9 • Number of events 1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/9 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/2 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
—
0/0 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
|
Renal and urinary disorders
Yeast Infection
|
16.7%
1/6 • Number of events 1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/8 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/8 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/10 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/9 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/9 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/2 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
—
0/0 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
0.00%
0/1 • Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
|
Additional Information
Dr. Nicolas Musi
San Antonio Geriatric Research, Education, and Clinical Center
Phone: (210) 562-6140
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place