The Effect of Metformin on Composition of Human Gut Bacteria

NCT ID: NCT02546050

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-02-29

Brief 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.

Detailed 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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Metformin

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.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Interventions

Metformin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oluf Borbye Pedersen

OTHER

Sponsor Role: lead

Responsible Party

Oluf Borbye Pedersen

Director, Professor, dr.med

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Oluf Pedersen, MD, Professor

Role: PRINCIPAL_INVESTIGATOR

The Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences University of Copenhagen

Locations

The Novo Nordisk Foundation Center of Basic Metabolic Research, Section for Metabolic Genetics, University of Copenhagen

Copenhagen, Copenhagen Ø, Denmark

Countries

Denmark

References

Bryrup T, Thomsen CW, Kern T, Allin KH, Brandslund I, Jorgensen NR, Vestergaard H, Hansen T, Hansen TH, Pedersen O, Nielsen T. Metformin-induced changes of the gut microbiota in healthy young men: results of a non-blinded, one-armed intervention study. Diabetologia. 2019 Jun;62(6):1024-1035. doi: 10.1007/s00125-019-4848-7. Epub 2019 Mar 23.

Reference Type: DERIVED

PMID: 30904939 (View on PubMed)

Other Identifiers

2015-000199-86

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NNF-CBMR 2015-000199-86

Identifier Type: -

Identifier Source: org_study_id