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 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT01984567
Eligibility Criteria:
Inclusion Criteria:
* Aged between 18 and 75 years
* Body Mass Index (BMI) between 20-35 kg/m2
* Mean serum total cholesterol \<8.0 mmol/L
* Mean serum triacylglycerol \<3.0 mmol/L
* Diagnosed with diabetes mellitus type 2 on a clinical basis or impaired glucose tolerance (defined as blood glucose \>7.8 mmol/l and \<11.0 mmol/L, two hours after ingesting 75 gram glucose in 150 ml water)
Exclusion Criteria:
* Unstable body weight (weight gain or loss \> 3 kg in the past two months)
* Active cardiovascular diseases like congestive heart failure or recent (\<6 months) event (acute myocardial infarction, cerebral vascular incident)
* Severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel disease and rheumatoid arthritis
* Use of medication such as corticosteroids, diuretics or lipid lowering therapy
* Use of insulin therapy
* Abuse of drugs or alcohol (\>21 units per week)
* Not willing to stop the consumption of vitamin supplements, containing lipoic acid and/or vitamin E, 1 month before the start of the study (wash-in period)
* Use of an investigational product within another biomedical study within the previous month
* Pregnant or breast-feeding women
* Current smoker
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01984567
Study Brief:
Protocol Section:
NCT01984567