NCT02033876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

May 8, 2019

Completed
Last Updated

May 8, 2019

Status Verified

April 1, 2019

Enrollment Period

3.3 years

First QC Date

January 9, 2014

Results QC Date

April 18, 2019

Last Update Submit

April 18, 2019

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change in Area Above Basal (AAB) for Glucose

    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).

    baseline, post-treatment approximately 14 - 17 days

Secondary Outcomes (7)

  • Change in Fasting Glucose

    baseline, post-treatment approximately 14 - 17 days

  • Change in Insulin Sensitivity

    baseline, post-treatment approximately 14 - 17 days

  • Gastric Emptying of Liquids (T1/2)

    post-treatment, approximately 14-17 days

  • Gastric Emptying of Solids (T1/2)

    post-treatment, approximately 14-17 days

  • Change in Weight

    baseline, post-treatment approximately 14 - 17 days

  • +2 more secondary outcomes

Study Arms (2)

Ursodiol

EXPERIMENTAL

Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily

Drug: Ursodiol

Placebo

PLACEBO COMPARATOR

matching placebo capsules to be taken twice daily

Drug: Ursodiol

Interventions

UrsodiolDRUG
Also known as: Ursodeoxycholic acid
PlaceboUrsodiol

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Calderon G, McRae A, Rievaj J, Davis J, Zandvakili I, Linker-Nord S, Burton D, Roberts G, Reimann F, Gedulin B, Vella A, LaRusso NF, Camilleri M, Gribble FM, Acosta A. Ileo-colonic delivery of conjugated bile acids improves glucose homeostasis via colonic GLP-1-producing enteroendocrine cells in human obesity and diabetes. EBioMedicine. 2020 May;55:102759. doi: 10.1016/j.ebiom.2020.102759. Epub 2020 Apr 25.

    PMID: 32344198DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Results Point of Contact

Title
Dr. Michael Camilleri
Organization
Mayo Clinic
camilleri.michael@mayo.edu
507-284-2687

Study Officials

  • Michael Camilleri, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Pharmacology and Physiology

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 13, 2014

Study Start

October 1, 2013

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

May 8, 2019

Results First Posted

May 8, 2019

Record last verified: 2019-04

Locations

US(1)