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
Results First Posted : May 8, 2019
Last Update Posted : May 8, 2019
|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 bile acid membrane receptor (TGR-5) and farnesol X (FXR) receptors in the ileum and colon, increasing the secretion of Fibroblast growth factor 19 (FGF-19), GLP-1, oxyntomodulin (OXM), and Peptide (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 gastric emptying (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
- Change in Area Above Basal (AAB) for Glucose [ Time Frame: baseline, post-treatment approximately 14 - 17 days ]Mixed meal glucose results are used to calculate the area above basal (AAB) for glucose. The glycemic index of a food is defined as the incremental area under the two-hour blood glucose response curve (AUC) following an overnight fast and ingestion of a food with a certain quantity of available carbohydrate (usually 50 g).
- Change in Fasting Glucose [ Time Frame: baseline, post-treatment approximately 14 - 17 days ]Serum glucose measurements taken after 10 hours of fasting.
- Change in Insulin Sensitivity [ Time Frame: baseline, post-treatment approximately 14 - 17 days ]Insulin sensitivity will be calculated by the oral minimal model.
- Gastric Emptying of Liquids (T1/2) [ Time Frame: post-treatment, approximately 14-17 days ]The time for half of the ingested liquids to leave the stomach. Following a meal with milk labeled with indium In111 diethylenetriaminepentaacetate (0.1 mCi), gastric emptying of liquids was assessed with scintigraphy imaging.
- Gastric Emptying of Solids (T1/2) [ Time Frame: post-treatment, approximately 14-17 days ]The time for half of the ingested solids to leave the stomach. Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi) served with 50g of Canadian bacon and one slice of bread gastric emptying of solids was assessed with scintigraphy imaging.
- Change in Weight [ Time Frame: baseline, post-treatment approximately 14 - 17 days ]Change in subject's weight, in kilograms
- Change in Body Mass Index [ Time Frame: baseline, post-treatment approximately 14 - 17 days ]Change in subjects BMI, in kilograms per meter squared.
- Change in FGF-19 [ Time Frame: baseline, post-treatment approximately 14 - 17 days ]Change in fasting fibroblast growth factor (FGF)-19 expression.
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|