Type 2 Diabetes Mellitus Clinical Trial
Official title:
Effect of Delayed-Release Bile Acid on Insulin Sensitivity, Gastric Emptying and Body Weight in Overweight or Obese Patients With Type 2 Diabetes Mellitus
Verified date | May 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | October 30, 2017 |
Est. primary completion date | October 18, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Satiogen Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Postprandial Glucose | Measurement of the glucose concentration in the bloodstream 6 hours after eating a meal | baseline to 1 month |
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