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 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT06115304
Eligibility Criteria:
Inclusion Criteria:
* 10 male patients with obesity (BMI \>30) and type 2 diabetes
* 10 male volunteers with normal weight (BMI 20-24) matched by age
* 10 male volunteers with obesity (BMI \>30) matched by age
Exclusion Criteria:
1. Unwillingness to participate or wish to withdraw from ongoing protocol
2. Hepatic disease or hemorrhagic diatheses (including abnormal International Normalized Ratio (INR), bilirubin, blood levels of thrombocytes, alanine-aminotransferase (ALAT))
3. Anticoagulant treatment (e.g. treatment with warfarin, apixaban or another oral anticoagulant)
4. Anaemia (p-hemoglobin below normal range)
5. Nephropathy (se-creatinine \>130 μM and/or albuminuria)
6. Suspected difficult access to the spinal canal (e.g. pronounced scoliosis, spinal stenosis, osteoporotic coincidence in the lower back, spina bifida, meningocele after surgical intervention)
7. Lumbar skin infection (e.g. herpes zoster, pustules or ulcers)
8. Medical history with headaches - both in connection with dura puncture and frequent headaches of other types
9. Central nervous system disease (including dementia, previous stroke, multiple sclerosis, epilepsy, etc.)
10. Clinical suspicion of increased intracranial pressure (headaches, visual disturbances etc.)
11. Patients with type 2 diabetes: Treatment with DPP-4 inhibitor or GLP-1 receptor agonist. Late diabetic complications including proliferative diabetic retinopathy (anamnestic), arteriosclerotic cardiovascular disease (heart failure or previous ischemic event/myocardial infarction)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT06115304
Study Brief:
Protocol Section:
NCT06115304