Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus

May 25, 2023 updated by: Andres J. Acosta, M.D., Ph.D., Mayo Clinic

Effect of Delayed-Release Bile Acid on Insulin Sensitivity, Gastric Emptying and Body Weight in Overweight or Obese Patients With Type 2 Diabetes Mellitus

To study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity, postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum FGF-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on therapy with DPP4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in combination with metformin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, placebo-controlled, parallel-group, single dose, randomized, controlled trial. Participants will receive 28 days (+/- 4 days) of treatment to study the effect of delayed (ileocolonic)-release ox bile extract 500 mg BID (twice daily) on insulin sensitivity, gastric emptying of liquids and solids (measured by scintigraphy) and weight loss I overweight and obese type 2 diabetic subjects. Participants will be receiving therapy with DPP4 inhibitors alone or in combination with metformin. Blood samples will be collected at defined times to measure glycemia, FGF-19 and incretins (GLP-1 [glucagon-like peptide-1], OXM [oxyntomodulin], PYY 3-36 [peptide YY]) fasting levels and responses to the meal.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. Overweight or obese subjects with BMI > 30 kg/m2 with type 2 diabetes mellitus taking DPP4 inhibitors alone or in combination with metformin.
  2. Women of childbearing potential will have a negative pregnancy test before initiation of medication and within 48 hours of receiving radioisotope.

Exclusion criteria:

  1. Structural of metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders.
  2. Irritable bowel syndrome
  3. Bristol stool type classification 4-7 per Bowel Disease questionnaire.
  4. Subjects with other treatment for type 2 diabetes mellitus.
  5. Subjects with HbA1c > 8%
  6. Females who are pregnant or breastfeeding
  7. Concomitant use of appetite suppressants, orlistat, phentermine-topiramate ER or lorcaserin.
  8. Subjects who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than type 2 diabetes mellitus), and unstable psychiatric disease.
  9. Subjects who have donated blood or plasma in the past 8 weeks.
  10. Subjects who have participated in another study within the past 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ox bile extract
Ox bile extract 500 mg tablets taken orally twice daily for 28 (+/- 4) days Gastric Emptying test, Waist and hip measurements, Mixed oral glucose tolerance test, Blood tests
Radiation: Gastric Emptying test
participants eat a standardized meal labeled with radioactive markers (99mTc DTPA [diethylenetriaminepentaacetic acid] and In111 Chloride). They have scans taken at specific times after the meal to document the rate of gastric emptying.
Other: Mixed Oral Glucose Tolerance test
Participants eat a meal containing 63g glucose in 240mL (milliliters) of skim milk, 2 scrambled eggs, 50g Canadian bacon and one slice of bread. Blood samples are taken prior to and for 6 hours after the meal at specific time points.
Drug: Conjugated bile acids sodium
500 mg tablets taken orally twice daily for 28 (+/- 4) days
Other Names:
  • Ox Bile extract
Placebo Comparator: Placebo
Matching placebo tablets taken orally twice daily for 28 (+/- 4) days Gastric Emptying test, Waist and hip measurements, Mixed oral glucose tolerance test, Blood tests
Radiation: Gastric Emptying test
participants eat a standardized meal labeled with radioactive markers (99mTc DTPA [diethylenetriaminepentaacetic acid] and In111 Chloride). They have scans taken at specific times after the meal to document the rate of gastric emptying.
Other: Mixed Oral Glucose Tolerance test
Participants eat a meal containing 63g glucose in 240mL (milliliters) of skim milk, 2 scrambled eggs, 50g Canadian bacon and one slice of bread. Blood samples are taken prior to and for 6 hours after the meal at specific time points.
Other: Placebo
Placebo tablets taken orally twice daily for 28 (+/- 4) days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Postprandial Glucose
Time Frame: baseline to 1 month
Measurement of the glucose concentration in the bloodstream 6 hours after eating a meal
baseline to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Satiogen Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Andres Acosta, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2016

Primary Completion (Actual)

October 18, 2017

Study Completion (Actual)

October 30, 2017

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimated)

August 18, 2016

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-007765

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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