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

Phase 1

Completed

• Conditions: Human Microbiome
• Interventions: Drug: Cholestyramine Resin

• Registration Number: NCT04335526
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-06
• Study Start: 2020-05-01
• Primary Completion: 2020-07-30
• Study Completion: 2020-10-21
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Metformin with cholestyramine	Cholestyramine Resin	-

Primary Outcome Measures

Name	Time	Method
Compare the maximum blood glucose concentration (Gmax)	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	Day 1/2/8/9	Compare how the gut microbiome species change between meformin alone and meformin with cholestyramine

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of