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Effects of metformin on human gut bacteria

Phase 1
Conditions
Young healthy men
MedDRA version: 20.0Level: PTClassification code 10062192Term: Metabolic function test normalSystem Organ Class: 10022891 - Investigations
MedDRA version: 20.0Level: PTClassification code 10053075Term: Microbiology testSystem Organ Class: 10022891 - Investigations
Therapeutic area: Body processes [G] - Physiological processes [G07]
Registration Number
EUCTR2015-000199-86-DK
Lead Sponsor
niversity of Copenhagen, The Novo Nordisk Foundation Center For Basic Metabolic Research, section of Metabolic Genetic
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Male
Target Recruitment
Not specified
Inclusion Criteria

Male
HbA1c < 5.7 % (39 mmol/mol) at time of screening; i.e. normal glucose metabolism
Caucasian (self-report of parental ethnicity)
Age 18 - 35 years
Weight stabile with 18.5 kg/m2 < BMI < 27.0 kg/m2
Normal kidney function as evaluated by normal p-creatinine for age

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Oral intake of any form of prescribed medication two months prior to recruitment
Chronic or acute illness
Previous gastro-intestinal operation excluding appendicitis
Any other significant medical reason for exclusion as determined by the investigator
Unable to give informed consent
Need of medical treatment during the study period

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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