A Clinical Study to Assess the Effect of Change of Bile Acid on the PD and Safety of Metformin and Microbiome Profiles
NCT ID: NCT04335526
Last Updated: 2021-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2020-05-01
2020-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Metformin alone
No interventions assigned to this group
Metformin with cholestyramine
Cholestyramine Resin
Change bile acid pool by cholestyramine treatment
Interventions
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Cholestyramine Resin
Change bile acid pool by cholestyramine treatment
Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
50 Years
MALE
Yes
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jae Yong Chung, MD, PhD
Professor
Principal Investigators
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Chung Jae Yong, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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MMP2
Identifier Type: -
Identifier Source: org_study_id
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