The Effect of Metformin on Composition of Human Gut Bacteria

NCT02546050 | Completed Phase 1 DMC

• 2 other identifiers: NNF-CBMR 2015-000199-862015-000199-86
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Gut microbiota; metformin; Metabolism; Metagenomics; Metabolomics

Outcome Measures

Primary Outcomes (1)

• Structural changes in the human gut microbiota.

  Fecal samples are collected in order to characterize the gut microbiota composition. Microbial DNA will be subjected to sequencing, microbial gene analyses, including taxonomic and functional annotation.

  Baseline, 4 , 7, 8, 10, 11 , 13, 16, and 18 weeks

Secondary Outcomes (14)

• Changes in plasma glucose and HbA1c levels

  Baseline and at week 7,10,13 and 18

• Changes in insulin metabolism

  Baseline and at week 7,10,13 and 18

• Changes in inflammatory markers in blood samples.

  Baseline and at week 7,10,13 and 18

• Changes in kidney function tests.

  Baseline and at week 7,10,13 and 18

• Changes in liver function tests.

  Baseline and at week 7,10,13 and 18

Study Arms (1)

Metformin

EXPERIMENTAL

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.

Drug: Metformin

Interventions

Metformin DRUG

Metformin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Oral intake of any form of prescribed medication two months prior to recruitment
• Chronic or acute illness
• Previous gastro-intestinal operation excluding appendicitis
• Unable to give informed consent
• Need of medical treatment during the study period

Sponsors & Collaborators

• Oluf Borbye Pedersen: lead

Study Sites (1)

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

Copenhagen, Copenhagen Ø, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 30904939 DERIVED

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Oluf Pedersen, MD, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Professor, dr.med

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: September 10, 2015
• Study Start: June 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

DK (1)