Status:
UNKNOWN
Postprandial Profiles of Metabolites and Appetite-regulating Hormones in Plasma and Cerebrospinal Fluid
Lead Sponsor:
Mikkel Bring Christensen
Conditions:
Obesity
Diabetes Mellitus, Type 2
Eligibility:
MALE
50-70 years
Phase:
NA
Brief Summary
Overweight and obesity are rising in prevalence and becoming a growing threat to public health. Obesity is associated with an increased all-cause mortality, impaired quality of life, and numerous of d...
Eligibility Criteria
Inclusion
- 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
- Unwillingness to participate or wish to withdraw from ongoing protocol
- Hepatic disease or hemorrhagic diatheses (including abnormal International Normalized Ratio (INR), bilirubin, blood levels of thrombocytes, alanine-aminotransferase (ALAT))
- Anticoagulant treatment (e.g. treatment with warfarin, apixaban or another oral anticoagulant)
- Anaemia (p-hemoglobin below normal range)
- Nephropathy (se-creatinine \>130 μM and/or albuminuria)
- 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)
- Lumbar skin infection (e.g. herpes zoster, pustules or ulcers)
- Medical history with headaches - both in connection with dura puncture and frequent headaches of other types
- Central nervous system disease (including dementia, previous stroke, multiple sclerosis, epilepsy, etc.)
- Clinical suspicion of increased intracranial pressure (headaches, visual disturbances etc.)
- 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)
Key Trial Info
Start Date :
October 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06115304
Start Date
October 5 2023
End Date
October 10 2024
Last Update
November 3 2023
Active Locations (1)
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1
Deparrtment of clinical pharmacology
Copenhagen, Denmark, 2400