Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus
Effect of Delayed-Release Bile Acid on Insulin Sensitivity, Gastric Emptying and Body Weight in Overweight or Obese Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 type-2-diabetes-mellitus
Started Sep 2016
1 active site
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
First Submitted
Initial submission to the registry
August 10, 2016
CompletedFirst Posted
Study publicly available on registry
August 18, 2016
CompletedStudy Start
First participant enrolled
September 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2017
CompletedResults Posted
Study results publicly available
May 31, 2023
CompletedMay 31, 2023
May 1, 2023
1.1 years
August 10, 2016
January 31, 2023
May 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Postprandial Glucose
Measurement of the glucose concentration in the bloodstream 6 hours after eating a meal
baseline to 1 month
Study Arms (2)
Ox bile extract
ACTIVE COMPARATOROx 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
Placebo
PLACEBO COMPARATORMatching placebo tablets taken orally twice daily for 28 (+/- 4) days Gastric Emptying test, Waist and hip measurements, Mixed oral glucose tolerance test, Blood tests
Interventions
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.
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.
500 mg tablets taken orally twice daily for 28 (+/- 4) days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Satiogen Pharmaceuticals, Inc.collaborator
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andres Acosta
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Andres Acosta, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
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
- PI
Study Record Dates
First Submitted
August 10, 2016
First Posted
August 18, 2016
Study Start
September 15, 2016
Primary Completion
October 18, 2017
Study Completion
October 30, 2017
Last Updated
May 31, 2023
Results First Posted
May 31, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share