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

Primary Purpose

Type 2 Diabetes Mellitus, Obese, Overweight

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gastric Emptying test
Mixed Oral Glucose Tolerance test
Conjugated bile acids sodium
Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ox bile extract

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Postprandial Glucose
Measurement of the glucose concentration in the bloodstream 6 hours after eating a meal

Secondary Outcome Measures

Full Information

First Posted
August 10, 2016
Last Updated
May 25, 2023
Sponsor
Mayo Clinic
Collaborators
Satiogen Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02871882
Brief Title
Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus
Official Title
Effect of Delayed-Release Bile Acid on Insulin Sensitivity, Gastric Emptying and Body Weight in Overweight or Obese Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2016 (Actual)
Primary Completion Date
October 18, 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Satiogen Pharmaceuticals, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Obese, Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ox bile extract
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Gastric Emptying test
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mixed Oral Glucose Tolerance test
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Conjugated bile acids sodium
Other Intervention Name(s)
Ox Bile extract
Intervention Description
500 mg tablets taken orally twice daily for 28 (+/- 4) days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets taken orally twice daily for 28 (+/- 4) days
Primary Outcome Measure Information:
Title
Change in Postprandial Glucose
Description
Measurement of the glucose concentration in the bloodstream 6 hours after eating a meal
Time Frame
baseline to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Overweight or obese subjects with BMI > 30 kg/m2 with type 2 diabetes mellitus taking DPP4 inhibitors alone or in combination with metformin. Women of childbearing potential will have a negative pregnancy test before initiation of medication and within 48 hours of receiving radioisotope. Exclusion criteria: Structural of metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders. Irritable bowel syndrome Bristol stool type classification 4-7 per Bowel Disease questionnaire. Subjects with other treatment for type 2 diabetes mellitus. Subjects with HbA1c > 8% Females who are pregnant or breastfeeding Concomitant use of appetite suppressants, orlistat, phentermine-topiramate ER or lorcaserin. 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. Subjects who have donated blood or plasma in the past 8 weeks. Subjects who have participated in another study within the past 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres Acosta, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32344198
Citation
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.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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