The Effect of Metformin on Composition of Human Gut Bacteria

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oluf Borbye Pedersen
• Treatments: Metformin

Criteria

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