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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT01435057
Eligibility Criteria:
Inclusion Criteria:
* BMI \>= 35 kg/m2
* waist circumference \>102cm (men), \>88cm (women)
* age 18 - 60 years
* written informed consent
Exclusion Criteria:
* type 1 or type 2 diabetes
* fasting plasma glucose \>= 6.0 mmol/l
* 2h-OGTT (oral glucose tolerance test) glucose \>= 11.1 mmol/l
* any chronic inflammatory or malignant disease
* medical treatment which influences glucose metabolism
* drug or alcohol abuse
* psychiatric disorders
* untreated thyroid dysfunction
* cardiac pacemaker or other contraindication for MRI
* attendant therapy with oral antidiabetic medication, GLP-1 mimetics or analoga, Insulin, anti-obesity medication (orlistat, sibutramine), Falithrom, antipsychotic drugs, any chemotherapeutics
* pregnant or nursing women
* expected low compliance
* current participation in another investigational trial
* last exercise training \<= 6 months ago
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01435057
Study Brief:
Protocol Section:
NCT01435057