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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT00943059
Eligibility Criteria:
Inclusion Criteria:
* Male or postmenopausal females
* Age 40-70 years
* Obese (BMI \> 30 kg/m2), non-insulin dependent type 2 diabetic patients and BMI matched control subjects without diabetes.
* Generally healthy with specifically no known cardiovascular disease, dyslipidemia, or gastric ulcers (contra-ind. of Acipimox), which can affect the study parameters.
* Must be on sulphonylurea(SU)- derivate or metformin therapy for at least six months with a constant dose for at least two months, or on dietary treatment for at least six months
* Well-controlled diabetes: HbA1c\<8%.
* Control subjects must have a plasma glucose lower than 6,1 mmol/L.
* Stable dietary habits (no weight loss/gain \> 3 kg in the last 6 months)
Exclusion Criteria:
* Known cardiovascular disease, dyslipidemia, hepatic or renal failure and gastric ulcers.
* Insulin dependent Diabetic patients.
* Use of lipid lowering agents, except from Statins, as these do not affect triglycerides levels (with exception to Lipitor).
* Use of Thiazolidines (glitazone/rosiglitazone/pioglitazone/troglitazone)
* Use of anti-coagulants (not thrombocyte-aggregation inhibitors)
* Aberrant ECG (with signs of ischemia or cardiac failure or arrythmia's)
* Weight gain/loss \> 3 kg in the last 6 months.
* Hb \< 7,3 in women, and \< 7,8 in men.
* Contraindications for MRI scans:
* Electronic implants such as pacemakers or neurostimulator
* Iron-containing corpora aliena in eyes or brain
* Some hearing aids and artificial (heart) valves which are contraindicated for MRS
* Claustrophobia
* Subjects, who do not want to be informed about unexpected medical findings, or do not wish that their physician is informed, cannot participate in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT00943059
Study Brief:
Protocol Section:
NCT00943059