NCT02871882

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Type 2 Diabetes Mellitus
• Obese
• Overweight

Interventions

Type	Name	Description
RADIATION	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.
OTHER	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.
DRUG	Conjugated bile acids sodium	500 mg tablets taken orally twice daily for 28 (+/- 4) days
OTHER	Placebo	Placebo tablets taken orally twice daily for 28 (+/- 4) days

Timeline

• Start date: 2016-09-15
• Primary completion: 2017-10-18
• Completion: 2017-10-30
• First posted: 2016-08-18
• Last updated: 2023-05-31
• Results posted: 2023-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study