Trial Outcomes & Findings for Beta Cell Restoration Through Fat Mitigation (NCT NCT01763346)
NCT ID: NCT01763346
Last Updated: 2019-10-21
Results Overview
mean plasma C-peptide concentration during clamp steady state, adjusted for mean clamp insulin sensitivity
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
24 months
Results posted on
2019-10-21
Participant Flow
Recruited from Kaiser Permanente Southern California
Five participants randomized to metformin and six participants randomized to gastric banding refused to initiate treatment
Participant milestones
| Measure |
Metformin
subjects receiving metformin
Metformin: metformin 1000 mg bid
|
Gastric Banding
subjects receiving LAP-BAND
gastric banding: LAP-BAND
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
|
Overall Study
Received Intervention
|
39
|
38
|
|
Overall Study
COMPLETED
|
34
|
36
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Beta Cell Restoration Through Fat Mitigation
Baseline characteristics by cohort
| Measure |
Metformin
n=44 Participants
subjects receiving metformin
Metformin: metformin 1000 mg bid
|
Gastric Banding
n=44 Participants
subjects receiving LAP-BAND
gastric banding: LAP-BAND
|
Total
n=88 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
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
44 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
Hyperglycemic clamp
|
3.37 nmol/l adjusted for insulin sensitivity
n=5 Participants
|
3.67 nmol/l adjusted for insulin sensitivity
n=7 Participants
|
3.52 nmol/l adjusted for insulin sensitivity
n=5 Participants
|
|
Oral Glucose Tolerance Test
fasting glucose
|
6.2 mmol/l
STANDARD_DEVIATION 0.8 • n=5 Participants
|
6.2 mmol/l
STANDARD_DEVIATION 0.7 • n=7 Participants
|
6.2 mmol/l
STANDARD_DEVIATION 0.75 • n=5 Participants
|
|
Oral Glucose Tolerance Test
2-hour glucose
|
10.5 mmol/l
STANDARD_DEVIATION 2.6 • n=5 Participants
|
10.4 mmol/l
STANDARD_DEVIATION 2.7 • n=7 Participants
|
10.45 mmol/l
STANDARD_DEVIATION 2.65 • n=5 Participants
|
|
Body weight
|
96.1 kilograms
STANDARD_DEVIATION 10.9 • n=5 Participants
|
97.5 kilograms
STANDARD_DEVIATION 12.2 • n=7 Participants
|
96.8 kilograms
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Body Mass Index
|
35.0 kilograms per meters squared
STANDARD_DEVIATION 2.9 • n=5 Participants
|
35.7 kilograms per meters squared
STANDARD_DEVIATION 2.9 • n=7 Participants
|
35.53 kilograms per meters squared
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Hemoglobin A1C
|
5.82 percent of hemoglobin
STANDARD_DEVIATION 0.06 • n=5 Participants
|
5.92 percent of hemoglobin
STANDARD_DEVIATION 0.06 • n=7 Participants
|
5.87 percent of hemoglobin
STANDARD_DEVIATION 0.06 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Participants completing 24-month hyperglycemic clamp
mean plasma C-peptide concentration during clamp steady state, adjusted for mean clamp insulin sensitivity
Outcome measures
| Measure |
Metformin
n=34 Participants
subjects receiving metformin
Metformin: metformin 1000 mg bid
|
Gastric Banding
n=36 Participants
subjects receiving LAP-BAND
gastric banding: LAP-BAND
|
|---|---|---|
|
Steady State Beta Cell Compensation
|
3.01 (nmol/L) adjusted for M/I
Interval 2.71 to 3.35
|
3.19 (nmol/L) adjusted for M/I
Interval 2.88 to 3.53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsPopulation: participants completing 24 months of interventions
fasting and 2-hour OGTT glucose levels
Outcome measures
| Measure |
Metformin
n=34 Participants
subjects receiving metformin
Metformin: metformin 1000 mg bid
|
Gastric Banding
n=36 Participants
subjects receiving LAP-BAND
gastric banding: LAP-BAND
|
|---|---|---|
|
Glycemia
fasting glucose
|
5.95 mmol/l
Standard Error 0.11
|
5.85 mmol/l
Standard Error 0.18
|
|
Glycemia
2-hour glucose
|
10.87 mmol/l
Standard Error 0.57
|
9.92 mmol/l
Standard Error 0.54
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsPopulation: participants completing 24 months of interventions
HbA1C
Outcome measures
| Measure |
Metformin
n=34 Participants
subjects receiving metformin
Metformin: metformin 1000 mg bid
|
Gastric Banding
n=36 Participants
subjects receiving LAP-BAND
gastric banding: LAP-BAND
|
|---|---|---|
|
Glycemia
|
5.84 percent of hemoglobin
Standard Error 0.09
|
5.73 percent of hemoglobin
Standard Error 0.09
|
Adverse Events
Metformin
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Gastric Banding
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metformin
n=39 participants at risk
subjects receiving metformin
Metformin: metformin 1000 mg bid
|
Gastric Banding
n=38 participants at risk
subjects receiving LAP-BAND
gastric banding: LAP-BAND
|
|---|---|---|
|
Gastrointestinal disorders
gastric band slippage requiring removal
|
0.00%
0/39 • 24 months
|
5.3%
2/38 • Number of events 2 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
0.00%
0/39 • 24 months
|
5.3%
2/38 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
acalcuous cholecystitis
|
0.00%
0/39 • 24 months
|
2.6%
1/38 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
2.6%
1/39 • Number of events 1 • 24 months
|
0.00%
0/38 • 24 months
|
|
Gastrointestinal disorders
Gastric sleeve surgery
|
2.6%
1/39 • Number of events 1 • 24 months
|
0.00%
0/38 • 24 months
|
Other adverse events
| Measure |
Metformin
n=39 participants at risk
subjects receiving metformin
Metformin: metformin 1000 mg bid
|
Gastric Banding
n=38 participants at risk
subjects receiving LAP-BAND
gastric banding: LAP-BAND
|
|---|---|---|
|
Gastrointestinal disorders
Port revision
|
0.00%
0/39 • 24 months
|
5.3%
2/38 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
dysphagia
|
0.00%
0/39 • 24 months
|
2.6%
1/38 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
stomach pain or discomfort
|
28.2%
11/39 • Number of events 11 • 24 months
|
0.00%
0/38 • 24 months
|
|
Gastrointestinal disorders
dairrhea
|
7.7%
3/39 • Number of events 3 • 24 months
|
0.00%
0/38 • 24 months
|
|
Psychiatric disorders
Depression
|
2.6%
1/39 • Number of events 1 • 24 months
|
0.00%
0/38 • 24 months
|
|
Gastrointestinal disorders
heartburn
|
2.6%
1/39 • Number of events 1 • 24 months
|
0.00%
0/38 • 24 months
|
|
Gastrointestinal disorders
nausea
|
2.6%
1/39 • Number of events 1 • 24 months
|
0.00%
0/38 • 24 months
|
|
General disorders
Lack of energy
|
2.6%
1/39 • Number of events 1 • 24 months
|
0.00%
0/38 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place