Young healthy men MedDRA version: 20.0 Level: PT Classification code 10062192 Term: Metabolic function test normal System Organ Class: 10022891 - Investigations MedDRA version: 20.0 Level: PT Classification code 10053075 Term: Microbiology test System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Metformin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: METFORMIN
CAS Number: 657-24-9
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 50
Sponsors
University of Copenhagen, The Novo Nordisk Foundation Center For Basic Metabolic Research, section of Metabolic Genetic
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male HbA1c =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Examine structural changes in gut microbiota before, during and after metformin treatmet.;Secondary Objective: Investigate changes in metabolic markers in urine, saliva, serum and fecal samples following metformin treatment.;Primary end point(s): Structural change of gut microbiota during and after metformin treatment. ;Timepoint(s) of evaluation of this end point: Spring 2016 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in metabolic markers in urine, saliva, serum and fecal samples during and after metformin treatment.;Timepoint(s) of evaluation of this end point: Fall 2016 | — |
Countries
Denmark
Contacts
Public ContactOluf Borbye Pedersen
University of Copenhagen, The Novo Nordisk Foundation Center For Basic Metabolic Research, section of Metabolic Genetic
Outcome results
None listed