This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatment ursodiol
Phase phase 2
Sponsor Mayo Clinic
Start date October 2013
End date October 2016
Trial size 24 participants
Trial identifier NCT02033876, 13-004908


This study will evaluate whether bile acids are able to increase insulin sensitivity and enhance glycemic control in T2DM patients, as well as exploring the mechanisms that enhance glycemic control. These observations will provide the preliminary data for proposing future therapeutic as well as further mechanistic studies of the role of bile acids in the control of glycemia in T2DM.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily
ursodiol Ursodeoxycholic acid
(Placebo Comparator)
matching placebo capsules to be taken twice daily
ursodiol Ursodeoxycholic acid

Primary Outcomes

Reduction in area above basal (AAB) for Glucose
time frame: 14-17days

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Overweight or Obese subjects with BMI> 25 Kg/m2 with Type 2 Diabetes mellitus on Metformin, receiving standard of care for Type 2 DM. Otherwise individuals who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than T2DM) and unstable psychiatric disease. Men or women. Women of childbearing potential will have a negative pregnancy test before initiation of medication.

Additional Information

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
Principal investigator Michael Camilleri, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Mayo Clinic.