EUCTR2016-001850-16-DK
Active, not recruiting
Phase 1
Studies of interplays between insulin resistance associated with immunosuppression and the gut and saliva microbiota composition of young, healthy men - GEMP
niversity of Copenhagen, The Novo Nordisk Foundation Center For Basic Metabolic Research, Section of Metabolic Genetic0 sitesMay 24, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Copenhagen, The Novo Nordisk Foundation Center For Basic Metabolic Research, Section of Metabolic Genetic
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Age 18\-35 years, both inclusive
- •\-18\.5 kg/m2 \< Body Mass Index (BMI) \< 27\.0 kg/m2
- •\-Weight stable, defined by no history of loss or gain of more than 3kg, two months prior to
- •recruitment
- •\-Normal glucose metabolism evaluated at the time of screening by Glycosylated Hemoglobin, Type A1c (HbA1c) \< 39mmol/mol
- •\-Normal kidney functions as evaluated by normal plasma creatinine levels adjusted for age
- •\-Normal liver function as evaluated by plasma Alanine Amino Transferase (ALAT) 10\-70 IU/L
- •\-Normal blood pressure measured with a calibrated automated sphygmomanometer. Systolic pressure \< 140mmHg and diastolic pressure \< 90mmHg
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •\-Smoking on daily basis
- •\-Oral intake of any form of prescribed medication four months prior to recruitment
- •\-Daily use of probiotics four months prior to recruitment
- •\-Deliberate changes in diet two months prior to recruitment
- •\-Chronic or acute (the latter within the recent two months) illness of any type
- •\-Previous gastrointestinal operation, disregarding uncomplicated appendicitis
- •\-Previous mental disorders
- •\-Unable to give informed consent
- •\-Need of medical treatment during the study
Outcomes
Primary Outcomes
Not specified
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