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

Phase 2

Completed

• Conditions: Obese; Overweight; Type 2 Diabetes Mellitus
• Interventions: Radiation: Gastric Emptying test; Other: Mixed Oral Glucose Tolerance test; Drug: Conjugated bile acids sodium; Other: Placebo

• Registration Number: NCT02871882
• Lead Sponsor: Mayo Clinic

Brief 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.

Study Timeline

• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-18
• Study Start: 2016-09-15
• Primary Completion: 2017-10-18
• Study Completion: 2017-10-30
• Results First Submitted: 2023-01-31
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-25
• Last Update Submitted: 2023-05-25
• Results First Posted: 2023-05-31
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Mixed Oral Glucose Tolerance test	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
Ox bile extract	Conjugated bile acids sodium	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
Placebo	Gastric Emptying test	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
Ox bile extract	Mixed Oral Glucose Tolerance test	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
Ox bile extract	Gastric Emptying test	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
Placebo	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

Primary Outcome Measures

Name	Time	Method
Change in Postprandial Glucose	baseline to 1 month	Measurement of the glucose concentration in the bloodstream 6 hours after eating a meal

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States