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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 1, 2021

Interventions

  • Drug: Cholestyramine Resin
    • Change bile acid pool by cholestyramine treatment

Arms, Groups and Cohorts

  • No Intervention: Metformin alone
  • Other: Metformin with cholestyramine

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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

Participating in This Clinical Trial

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
  • Gender Eligibility: Male

    Minimum Age: 19 Years

    Maximum Age: 50 Years

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • Seoul National University Hospital
    • Provider of Information About this Clinical Study
      • Principal Investigator: Jae Yong Chung, MD, PhD, Professor – Seoul National University Hospital
    • Overall Contact(s)
      • Chung Jae Yong, MD, PhD, +82-31-787-3968, mekka@snu.ac.kr

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