The Effect of Metformin on Composition of Human Gut Bacteria

Oluf Borbye Pedersen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02546050

NNF-CBMR 2015-000199-86

2015-000199-86 (EudraCT Number)

Details and patient eligibility

About

OBJECTIVE: Investigate structural changes in the human gut microbiota and associated changes in metabolic markers in urine, saliva, blood and fecal samples following metformin treatment.

DESIGN: An, 18 week, one-armed cross over intervention trial consisting of a 6-week pre-intervention period, 6-week intervention period and a 6-week post-intervention period. 25 healthy young men will be included in the trial.

INTERVENTION: Six-week Metformin treatment to young healthy men.

Full description

An, 18 weeks, one-armed cross over intervention trial consisting of a 6-weeks pre-intervention period, 6-weeks intervention period and a 6-weeks post-intervention period. 25 healthy young men will be included in the trial. The pre-intervention period is the control period with no treatment. During the intervention period participants will receive 500 mg of metformin once daily the 1st week, then 500 mg twice daily the 2nd week, 1000 mg + 500 mg daily the 3rd week and 1000 mg + 1000 mg daily the remaining three weeks. Post-interventional investigators will examine gut microbiota of the participants 6 weeks after completion of the intervention period.

MESUREMENTS: Altered composition of gut microbiota as investigated by 16S rRNA sequencing is the primary outcome of this study. Secondary outcomes are to investigate changes in metabolic and inflammatory markers in blood and fecal samples. Blood, urine, saliva and fecal samples will be stored for future studies.

Enrollment: 26 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male
• HbA1c < 5.7 % (39 mmol/mol)
• Caucasian (self-report of parental ethnicity)
• Weight stabile with 18.5 kg/m2 < BMI < 27.0 kg/m2
• Normal kidney function as evaluated by normal p-creatinine for age

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Metformin

Experimental group

Description:

18 weeks study with intervention during week 6 to 12: the intervention consist of 500 mg of metformin once daily for week 7, then 500 mg twice daily week 8, 1000 mg + 500 mg daily week 9 and 1000 mg + 1000 mg daily for weeks 10-12.

Treatment:

Drug: Metformin