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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
Sponsor:
Information provided by (Responsible Party):
Michael Camilleri, Mayo Clinic

January 9, 2014
January 13, 2014
November 13, 2017
October 2013
January 2017   (Final data collection date for primary outcome measure)
Reduction in area above basal (AAB) for Glucose [ Time Frame: 14-17days ]
Same as current
Complete list of historical versions of study NCT02033876 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Ursodiol on Insulin Sensitivity, Gastric Emptying and Body Weight With Type 2 Diabetes on Metformin
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
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: Ursodiol
Other Name: Ursodeoxycholic acid
  • Experimental: Ursodiol
    Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily
    Intervention: Drug: Ursodiol
  • Placebo Comparator: Placebo
    matching placebo capsules to be taken twice daily
    Intervention: Drug: Ursodiol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
Same as current
March 2017
January 2017   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02033876
13-004908
No
Not Provided
Not Provided
Michael Camilleri, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Michael Camilleri, MD Mayo Clinic
Mayo Clinic
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP