A Clinical Study to Assess the Effect of Change of Bile Acid on the PD and Safety of Metformin and Microbiome Profiles

March 15, 2021 updated by: Jae Yong Chung, MD, PhD, Seoul National University Hospital

A Clinical Study for Assessing the Effect of Change of Bile Acid Pool on the Pharmacodynamics and Safety of Metformin and Intestinal Microbiome Profiles in Healthy Volunteers

This clinical trial is intended to evaluate the effect of change of bile acid pool with cholestyramine on the pharmacodynamics and safety of metformin and intestinal microbiome profiles in healthy volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

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

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

19 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age between 19 to 50, healthy male subjects(at screening)
  • Body weight between 50.0 kg - 100.0 kg, BMI between 18.0 - 28.0 kg/m2
  • Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress

Exclusion Criteria:

  • Subject who has a past or present history of any diseases following below.(liver, kidney, neurology, immunology, pulmonary, endocrine, hematology, oncology, cardiology, mental disorder)
  • Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery (appendectomy, hernioplasty are excluded)
  • Serum AST(SGOT), ALT(SGPT)>2 times upper limit of normal range MDRD eGFR <80mL/min/1.73m2
  • Subject who had drug (Aspirin, antibiotics) hypersensitivity reaction
  • Subject who already participated in other trials in 3 months
  • Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Metformin alone
Other: Metformin with cholestyramine
Drug: Cholestyramine Resin
Change bile acid pool by cholestyramine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the maximum blood glucose concentration (Gmax)
Time Frame: Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
Compare the maximum blood glucose concentration (Gmax) between meformin alone and meformin with cholestyramine
Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
Compare the maximum blood glucose concentration (Gmax)
Time Frame: Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
Compare the area under the blood glucose concentration versus time curve (AUC) between meformin alone and meformin with cholestyramine
Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
Compare the gut microbiome species change
Time Frame: Day 1/2/8/9
Compare how the gut microbiome species change between meformin alone and meformin with cholestyramine
Day 1/2/8/9

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Chung Jae Yong, MD, PhD, Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Bundang Hospital

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)

May 1, 2020

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

October 21, 2020

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 3, 2020

First Posted (Actual)

April 6, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMP2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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