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

Mayo Clinic24 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Type 2 Diabetes Mellitus Obese Overweight

Interventions

Gastric Emptying testRADIATION

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 testOTHER

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 sodiumDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Change in Postprandial Glucose

Measurement of the glucose concentration in the bloodstream 6 hours after eating a meal

Time frame: baseline to 1 month

Data from ClinicalTrials.gov

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