Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT02291458
Eligibility Criteria:
Inclusion Criteria:
* Caucasian or South Asian ethnicity
* Age: 35-50 years
* Gender: male
* BMI: 25-30 kg/m2
* Plasma glucose levels 2 h after OGTT between 7.8 and 11 mM (e.g. impaired glucose tolerance) or Fasting plasma glucose levels \> 5.5 mM
* Good general health
Exclusion Criteria:
* Type 2 diabetes (determined on basis of oral glucose tolerance test (OGTT))
* BMI \> 30 kg/m2
* Plasma glucose levels 2 h after OGTT \< 7.8 mM
* Plasma L-arginine levels \< 41 or \> 114 uM
* Use of beta-blockers (these inhibit BAT activity) \< 1 month before start of study or during study
* Systolic blood pressure \< 90 mmHg
* Haematocrit \< 0.41 or \> 0.51 l/l
* Haemoglobin \< 8.5 or \> 11.0
* Creatinine (enzymatic method) \< 45 or \> 100 μmol/L
* ASAT \> 45 U/L
* ALAT \> 50 U/L
* Alkaline phosphatase \> 125 U/L
* Gamma GT \> 45 U/L
* Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study
* Abuse of drugs and/or alcohol
* Hyperthyroidism or hypothyroidism
* Participation in earlier research or medical examinations that included PET-CT scanning
* Psychologically unstable subjects (as judged by the treating medical specialist)
* Subjects with mental retardation (as judged by the treating medical specialist)
* Subjects with severe behaviour disorders (as judged by the treating medical specialist)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
35 Months
Maximum Age:
50 Years
Study:
NCT02291458
Study Brief:
Protocol Section:
NCT02291458