--- title: Ursodiol on Insulin Sensitivity, Gastric Emptying and Body Weight With Type 2 Diabetes on Metformin nct_id: NCT02033876 overall_status: COMPLETED phase: PHASE2 sponsor: Mayo Clinic study_type: INTERVENTIONAL primary_condition: Type 2 Diabetes Mellitus countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02033876.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02033876" ct_last_update_post_date: 2019-05-08 last_seen_at: "2026-05-12T06:49:32.785Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Ursodiol on Insulin Sensitivity, Gastric Emptying and Body Weight With Type 2 Diabetes on Metformin **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 **NCT ID:** [NCT02033876](https://clinicaltrials.gov/study/NCT02033876) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 24 - **Lead Sponsor:** Mayo Clinic - **Conditions:** Type 2 Diabetes Mellitus - **Start Date:** 2013-10 - **Completion Date:** 2017-03 - **CT.gov Last Update:** 2019-05-08 ## Brief Summary 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. ## Detailed Description 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. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 70 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. ``` ## Arms - **Ursodiol** (EXPERIMENTAL) — Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily - **Placebo** (PLACEBO_COMPARATOR) — matching placebo capsules to be taken twice daily ## Interventions - **Ursodiol** (DRUG) ## Primary Outcomes - **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). ## Secondary Outcomes - **Change in Fasting Glucose** _(time frame: baseline, post-treatment approximately 14 - 17 days)_ - **Change in Insulin Sensitivity** _(time frame: baseline, post-treatment approximately 14 - 17 days)_ - **Gastric Emptying of Liquids (T1/2)** _(time frame: post-treatment, approximately 14-17 days)_ - **Gastric Emptying of Solids (T1/2)** _(time frame: post-treatment, approximately 14-17 days)_ - **Change in Weight** _(time frame: baseline, post-treatment approximately 14 - 17 days)_ - **Change in Body Mass Index** _(time frame: baseline, post-treatment approximately 14 - 17 days)_ - **Change in FGF-19** _(time frame: baseline, post-treatment approximately 14 - 17 days)_ ## Locations (1) - Mayo Clinic in Rochester, Rochester, Minnesota, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.mayo clinic in rochester|rochester|minnesota|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02033876.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02033876* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*