Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-15

Study Completion Date

2017-10-30

Brief Summary

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To study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity, postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum FGF-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on therapy with DPP4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in combination with metformin.

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Detailed Description

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This is a single-center, placebo-controlled, parallel-group, single dose, randomized, controlled trial. Participants will receive 28 days (+/- 4 days) of treatment to study the effect of delayed (ileocolonic)-release ox bile extract 500 mg BID (twice daily) on insulin sensitivity, gastric emptying of liquids and solids (measured by scintigraphy) and weight loss I overweight and obese type 2 diabetic subjects. Participants will be receiving therapy with DPP4 inhibitors alone or in combination with metformin. Blood samples will be collected at defined times to measure glycemia, FGF-19 and incretins (GLP-1 \[glucagon-like peptide-1\], OXM \[oxyntomodulin\], PYY 3-36 \[peptide YY\]) fasting levels and responses to the meal.

Conditions

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Type 2 Diabetes Mellitus Obese Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Gastric Emptying test

Intervention Type RADIATION

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

Intervention Type OTHER

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

Intervention Type DRUG

500 mg 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

Group Type PLACEBO_COMPARATOR

Gastric Emptying test

Intervention Type RADIATION

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

Intervention Type OTHER

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.

Placebo

Intervention Type OTHER

Placebo tablets taken orally twice daily for 28 (+/- 4) days

Interventions

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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.

Intervention Type RADIATION

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.

Intervention Type OTHER

Conjugated bile acids sodium

500 mg tablets taken orally twice daily for 28 (+/- 4) days

Intervention Type DRUG

Placebo

Placebo tablets taken orally twice daily for 28 (+/- 4) days

Intervention Type OTHER

Other Intervention Names

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Ox Bile extract

Eligibility Criteria

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Inclusion Criteria

1. Overweight or obese subjects with BMI \> 30 kg/m2 with type 2 diabetes mellitus taking DPP4 inhibitors alone or in combination with metformin.
2. Women of childbearing potential will have a negative pregnancy test before initiation of medication and within 48 hours of receiving radioisotope.

Exclusion Criteria

1. Structural of metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders.
2. Irritable bowel syndrome
3. Bristol stool type classification 4-7 per Bowel Disease questionnaire.
4. Subjects with other treatment for type 2 diabetes mellitus.
5. Subjects with HbA1c \> 8%
6. Females who are pregnant or breastfeeding
7. Concomitant use of appetite suppressants, orlistat, phentermine-topiramate ER or lorcaserin.
8. Subjects who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than type 2 diabetes mellitus), and unstable psychiatric disease.
9. Subjects who have donated blood or plasma in the past 8 weeks.
10. Subjects who have participated in another study within the past 30 days.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No