Trial Outcomes & Findings for Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus (NCT NCT02871882)
NCT ID: NCT02871882
Last Updated: 2023-05-31
Results Overview
Measurement of the glucose concentration in the bloodstream 6 hours after eating a meal
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
baseline to 1 month
Results posted on
2023-05-31
Participant Flow
Participant milestones
| Measure |
Ox Bile Extract
Ox bile extract 500 mg tablets taken orally twice daily for 28 (+/- 4) days Gastric Emptying test, Waist and hip measurements, Mixed oral glucose tolerance test, Blood tests
Gastric Emptying test: participants eat a standardized meal labeled with radioactive markers (99mTc DTPA \[diethylenetriaminepentaacetic acid\] and In111 Chloride). They have scans taken at specific times after the meal to document the rate of gastric emptying.
Mixed Oral Glucose Tolerance test: Participants eat a meal containing 63g glucose in 240mL (milliliters) of skim milk, 2 scrambled eggs, 50g Canadian bacon and one slice of bread. Blood samples are taken prior to and for 6 hours after the meal at specific time points.
Conjugated bile acids sodium: 500 mg tablets taken orally twice daily for 28 (+/- 4) days
Placebo: Placebo tablets taken orally twice daily for 28 (+/- 4) days
|
Placebo
Matching placebo tablets taken orally twice daily for 28 (+/- 4) days Gastric Emptying test, Waist and hip measurements, Mixed oral glucose tolerance test, Blood tests
Gastric Emptying test: participants eat a standardized meal labeled with radioactive markers (99mTc DTPA \[diethylenetriaminepentaacetic acid\] and In111 Chloride). They have scans taken at specific times after the meal to document the rate of gastric emptying.
Mixed Oral Glucose Tolerance test: Participants eat a meal containing 63g glucose in 240mL (milliliters) of skim milk, 2 scrambled eggs, 50g Canadian bacon and one slice of bread. Blood samples are taken prior to and for 6 hours after the meal at specific time points.
Conjugated bile acids sodium: 500 mg tablets taken orally twice daily for 28 (+/- 4) days
Placebo: Placebo tablets taken orally twice daily for 28 (+/- 4) days
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Ox Bile Extract
n=11 Participants
Ox bile extract 500 mg tablets taken orally twice daily for 28 (+/- 4) days Gastric Emptying test, Waist and hip measurements, Mixed oral glucose tolerance test, Blood tests
Gastric Emptying test: participants eat a standardized meal labeled with radioactive markers (99mTc DTPA \[diethylenetriaminepentaacetic acid\] and In111 Chloride). They have scans taken at specific times after the meal to document the rate of gastric emptying.
Mixed Oral Glucose Tolerance test: Participants eat a meal containing 63g glucose in 240mL (milliliters) of skim milk, 2 scrambled eggs, 50g Canadian bacon and one slice of bread. Blood samples are taken prior to and for 6 hours after the meal at specific time points.
Conjugated bile acids sodium: 500 mg tablets taken orally twice daily for 28 (+/- 4) days
Placebo: Placebo tablets taken orally twice daily for 28 (+/- 4) days
|
Placebo
n=12 Participants
Matching placebo tablets taken orally twice daily for 28 (+/- 4) days Gastric Emptying test, Waist and hip measurements, Mixed oral glucose tolerance test, Blood tests
Gastric Emptying test: participants eat a standardized meal labeled with radioactive markers (99mTc DTPA \[diethylenetriaminepentaacetic acid\] and In111 Chloride). They have scans taken at specific times after the meal to document the rate of gastric emptying.
Mixed Oral Glucose Tolerance test: Participants eat a meal containing 63g glucose in 240mL (milliliters) of skim milk, 2 scrambled eggs, 50g Canadian bacon and one slice of bread. Blood samples are taken prior to and for 6 hours after the meal at specific time points.
Conjugated bile acids sodium: 500 mg tablets taken orally twice daily for 28 (+/- 4) days
Placebo: Placebo tablets taken orally twice daily for 28 (+/- 4) days
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
53 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 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
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 1 monthMeasurement of the glucose concentration in the bloodstream 6 hours after eating a meal
Outcome measures
| Measure |
Ox Bile Extract
n=11 Participants
Ox bile extract 500 mg tablets taken orally twice daily for 28 (+/- 4) days Gastric Emptying test, Waist and hip measurements, Mixed oral glucose tolerance test, Blood tests
Gastric Emptying test: participants eat a standardized meal labeled with radioactive markers (99mTc DTPA \[diethylenetriaminepentaacetic acid\] and In111 Chloride). They have scans taken at specific times after the meal to document the rate of gastric emptying.
Mixed Oral Glucose Tolerance test: Participants eat a meal containing 63g glucose in 240mL (milliliters) of skim milk, 2 scrambled eggs, 50g Canadian bacon and one slice of bread. Blood samples are taken prior to and for 6 hours after the meal at specific time points.
Conjugated bile acids sodium: 500 mg tablets taken orally twice daily for 28 (+/- 4) days
Placebo: Placebo tablets taken orally twice daily for 28 (+/- 4) days
|
Placebo
n=12 Participants
Matching placebo tablets taken orally twice daily for 28 (+/- 4) days Gastric Emptying test, Waist and hip measurements, Mixed oral glucose tolerance test, Blood tests
Gastric Emptying test: participants eat a standardized meal labeled with radioactive markers (99mTc DTPA \[diethylenetriaminepentaacetic acid\] and In111 Chloride). They have scans taken at specific times after the meal to document the rate of gastric emptying.
Mixed Oral Glucose Tolerance test: Participants eat a meal containing 63g glucose in 240mL (milliliters) of skim milk, 2 scrambled eggs, 50g Canadian bacon and one slice of bread. Blood samples are taken prior to and for 6 hours after the meal at specific time points.
Conjugated bile acids sodium: 500 mg tablets taken orally twice daily for 28 (+/- 4) days
Placebo: Placebo tablets taken orally twice daily for 28 (+/- 4) days
|
|---|---|---|
|
Change in Postprandial Glucose
|
-2803 mmol/6hr
Interval -5724.0 to 1098.0
|
629 mmol/6hr
Interval -4779.0 to 3814.0
|
Adverse Events
Ox Bile Extract
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place