Postprandial Profiles of Metabolites and Appetite-regulating Hormones in Plasma and Cerebrospinal Fluid

Launched by MIKKEL BRING CHRISTENSEN · Oct 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of food and certain medications on specific substances in the blood and spinal fluid of people who are overweight or have type 2 diabetes. Researchers want to learn more about how these substances might be connected to appetite and metabolism, which can help in understanding and treating obesity and diabetes better. The study is looking for male participants aged between 18 and 65. They need to either have obesity and type 2 diabetes, or be healthy volunteers with normal weight or obesity, to compare the results.

If you qualify and decide to participate, you will have a meal and take part in tests to measure various markers in your blood and spinal fluid. It’s important to know that certain health conditions, such as liver disease, blood disorders, or issues with the nervous system, may prevent you from being eligible for the study. Participating in this trial could contribute to important research that aims to improve treatment options for obesity and diabetes, which are significant health concerns today.

Gender

MALE

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)