Title
Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus
Effect of Delayed-Release Bile Acid on Insulin Sensitivity, Gastric Emptying and Body Weight in Overweight or Obese Patients With Type 2 Diabetes Mellitus
Phase
Phase 2Lead Sponsor
Mayo ClinicStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Type 2 Diabetes Mellitus Obese OverweightIntervention/Treatment
conjugated bile acids glucose ...Study Participants
24To 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.
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.
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.
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.
500 mg tablets taken orally twice daily for 28 (+/- 4) days
Placebo tablets taken orally twice daily for 28 (+/- 4) days
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
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
Inclusion criteria: Overweight or obese subjects with BMI > 30 kg/m2 with type 2 diabetes mellitus taking DPP4 inhibitors alone or in combination with metformin. Women of childbearing potential will have a negative pregnancy test before initiation of medication and within 48 hours of receiving radioisotope. Exclusion criteria: Structural of metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders. Irritable bowel syndrome Bristol stool type classification 4-7 per Bowel Disease questionnaire. Subjects with other treatment for type 2 diabetes mellitus. Subjects with HbA1c > 8% Females who are pregnant or breastfeeding Concomitant use of appetite suppressants, orlistat, phentermine-topiramate ER or lorcaserin. 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. Subjects who have donated blood or plasma in the past 8 weeks. Subjects who have participated in another study within the past 30 days.
| Event Type | Organ System | Event Term |
|---|
Measurement of the glucose concentration in the bloodstream 6 hours after eating a meal
