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:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT03230812
Eligibility Criteria:
Inclusion Criteria:
* Men and woman
* Age: 40-75 years
* Woman should be postmenopausal
* BMI: 25-38 kg/m2
* Stable dietary habits
* No use of medication interfering with investigated study parameters (as determined by responsible physician)
* Use of oral glucose lowering medication (metformin only or in combination with sulfonylurea agents)
Exclusion Criteria:
* Haemoglobin levels \< 7.8 mmol/L
* Uncontrolled hypertension
* Use of anticoagulants
* Insulin dependent type 2 diabetic patients.
* No signs of active liver or kidney malfunction.
* Engagement in exercise \> 3 hours a week
* Being vegetarian or vegan (because of altered whole body carnitine status)
* Alcohol and/or drug abuse
* Unstable body weight (weight gain or loss \> 5kg in the last 3 months)
* Significant food allergies/intolerances (seriously hampering study meals)
* Participation in another biomedical study within 1 month before the first study visit, which would possibly hamper our study results
* Medication use known to hamper subject's safety during the study procedures
* Subjects with contra-indications for MRI
* Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the study
* Subjects who do not want to be informed about unexpected medical findings
* No signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT03230812
Study Brief:
Protocol Section:
NCT03230812