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:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT01803568
Eligibility Criteria:
Inclusion Criteria:
* Male
* Age 40-65 years
* Nordic ethnicity
* Non-smoker
1. Either (participants with impaired glucose metabolism): Body Mass Index (BMI) 27-32 kg/m2 and abnormal glucose metabolism, defined as:
i. impaired fasting glucose (FPG ≥ 5.6 mmol/L) ii. impaired glucose tolerance (2 h PG ≥7.8 mmol/L) iii. type 2 diabetes (no medication, HbA1c ≤7.5%)
2. Or (controls): BMI 19-25 kg/m2 and normal glucose metabolism and no first degree relatives with type 2 diabetes.
Exclusion Criteria:
1. Subjects having type 1 diabetes or medically treated type 2 diabetes.
2. Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 90 mmHg at screening
3. Significant hematological or renal disease or chronic renal impairment, GFR\< 50 ml/min.
4. Significant liver disease or ALAT \>3x UNL.
5. Chronic inflammatory disease in active phase or long-term use of corticosteroids last 3 months.
6. Use of anti-diabetic agents, lipid lowering drugs, antihypertensive medication, ASA or any other drug not deemed suitable by the study physician.
7. Mental condition (psychiatric or organic cerebral disease), drug or alcohol abuse rendering the subject unable to understand the nature, scope and possible consequences of the study.
8. BMI outside inclusion criteria.
9. Smoker
10. Any medical or other condition that in the judgment of the investigator would jeopardize the subject's safety or evaluation of the intervention for efficacy and safety
11. Exercising regularly (\>1 times pr week)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT01803568
Study Brief:
Protocol Section:
NCT01803568