Type 2 Diabetes Mellitus Clinical Trial
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
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 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.
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