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 @ 2:04 PM
Ignite Modification Date:
2025-12-24 @ 2:04 PM
NCT ID:
NCT01947595
Eligibility Criteria:
Inclusion Criteria:
* impaired fasting glucose (IFG)
* fasting blood glucose 99-126 mg/dl
and/or
* impaired glucose tolerance (IGT)
* 75 g OGTT 120 minutes: 139-200 mg/dl
Exclusion Criteria:
* current pregnancy or breastfeeding
* BMI \> 45 kg/m²
* Diabetes mellitus Typ 1 or 2
* serious disease e.g symptomatic coronary heart disease
* serious symptomatic malignant disease (weight loss \> 10% within the last 6 month)
* severe liver or kidney disease ( an increase in transaminases \> 3 times than the upper limit of the standardized range, GFR \< 50 ml/min/1,73m²)
* systemic infection (CRP \> 1 mg/dl)
* severe mental illness
* drug abuse
* treatment with steroids
* potentially incompliant subjects
* exclusion criteria for magnetic resonance tomography
* any kind of metal in or on the body:
* cardiac pacemakers
* prosthetic heart valves
* metal prosthesis
* magnetic implanted metallic parts
* contraceptive coil
* metal fragments/ grenade shrapnel
* fixed braces
* acupuncture needles
* insulin pump
* intraport etc.
* Field strength \> 3 Tesla further tattoos, permanent make-up
* persons with limited thermosensory or heightened sensitivity to heating
* persons where cardiovascular disease cannot be ruled out by examination
* persons with heightened sensitivity to loud noise or diseases of the ear
* used closed whole body scanner: claustrophobia
Additional for spirometry
* acute coronary syndrome
* higher cardiac arrhythmia
* decompensated heart failure
* acute carditis
* pulmonary embolism
* acute deep leg vein thrombosis ( phlebothrombosis)
* hyperthyroidism (TSH)
* hypokalemia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01947595
Study Brief:
Protocol Section:
NCT01947595