Ursodiol on Insulin Sensitivity, Gastric Emptying and Body Weight With Type 2 Diabetes on Metformin
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|ClinicalTrials.gov Identifier: NCT02033876|
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : November 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Ursodiol||Phase 2|
Background: Intra-jejunal administration of bile acids improves insulin sensitivity.
Hypothesis: The bile acid, ursodeoxycholic acid (UDCA) in delayed (ileocolonic)-release formulation, stimulates TGR-5 and FXR receptors in the ileum and colon, increasing the secretion of FGF-19, GLP-1, oxyntomodulin (OXM), and PYY3-36, improving insulin sensitivity and inducing weight loss.
Aim: To study the effect of an ileocolonic formulation of UDCA on insulin sensitivity, postprandial plasma glycemia and incretin levels, gastric emptying and body weight in overweight or obese type 2 diabetic subjects on monotherapy with metformin.
Study design: This is a single center, placebo-controlled, parallel group, single dose randomized controlled trial to study the effect of delayed (ileocolonic)-release UDCA 600 mg twice daily on insulin sensitivity, gastric emptying of liquids and solids (measured by scintigraphy)and weight loss in overweight or obese type 2 diabetic subjects. Participants will be receiving monotherapy with metformin. Blood samples will be collected at defined times to measure glycemia and the incretin (GLP-1, OXM, PYY3-36) fasting levels and responses to the meal.
Anticipated Results: In comparison with placebo, UDCA will increase insulin sensitivity, enhance glycemic control, increase postprandial incretins, and delay GE of liquids.
Significance: This study will prove that ileocolonic-release UDCA enhances glycemic control in T2DM patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of Delayed-Release Ursodeoxycholic Acid on Insulin Sensitivity, Gastric Emptying and Body Weight in Overweight or Obese Patients With Type 2 Diabetes on Metformin Treatment|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||March 2017|
Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily
Other Name: Ursodeoxycholic acid
Placebo Comparator: Placebo
matching placebo capsules to be taken twice daily
Other Name: Ursodeoxycholic acid
- Reduction in area above basal (AAB) for Glucose [ Time Frame: 14-17days ]
- Fasting glucose [ Time Frame: 14-17 days ]
- Insulin sensitivity calculated by the oral minimal model [ Time Frame: 14 - 17 days ]
- Gastric emptying of liquids (T1/2) [ Time Frame: 14 - 17 days ]
- Gastric emptying of solids (T1/2) [ Time Frame: 14 - 17 days ]
- Weight change, kg [ Time Frame: 14 - 17 days ]
- Insulin secretion calculated by the oral minimal model [ Time Frame: 14 - 17 days ]
- 24 hour colonic geometric center [ Time Frame: 14 - 17 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033876
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Michael Camilleri, MD||Mayo Clinic|