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Clinical Trials/EUCTR2016-001850-16-DK
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.

Registry
who.int
Start Date
May 24, 2016
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
niversity of Copenhagen, The Novo Nordisk Foundation Center For Basic Metabolic Research, Section of Metabolic Genetic

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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