Examining how meals affect hormones and metabolites in people with obesity and diabetes
Postprandial Profiles of Metabolites and Appetite-regulating Hormones in Plasma and Cerebrospinal Fluid
This study is testing how a big liquid meal affects hormones and other substances in the blood and spinal fluid of men with obesity and type 2 diabetes compared to healthy individuals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 50 Years to 70 Years |
| Sex | Male |
| Sponsor | Bispebjerg Hospital Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06115304 on ClinicalTrials.gov |
What this trial studies
This research project aims to investigate the profiles of specific biomarkers in plasma and cerebrospinal fluid after participants consume a large liquid meal alongside model pharmaceuticals. The study will include male patients with obesity and type 2 diabetes, as well as healthy controls, to compare their metabolic responses. By understanding gut-to-brain signaling and hormonal changes, the research seeks to shed light on the metabolic disturbances associated with obesity. The methodology involves the use of a spinal catheter and venous line to collect necessary samples for analysis.
Who should consider this trial
Good fit: Ideal candidates include male patients with obesity and type 2 diabetes, as well as healthy male volunteers matched by age.
Not a fit: Patients with conditions such as hepatic disease, nephropathy, or those on anticoagulant treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved therapeutic strategies for managing obesity and type 2 diabetes.
How similar studies have performed: While the approach of examining gut-to-brain signaling is gaining interest, this specific methodology appears to be novel and untested in this context.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Copenhagen
- Deparrtment of clinical pharmacology — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Mikkel.bring.christensen@regionh.dk B Christensen, MD, PhD — Department of clinical pharmacology, Bispebjerg Hospital
- Study coordinator: Mikkel B Christensen, MD, PhD
- Email: Mikkel.bring.christensen@regionh.dk
- Phone: +4538635102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.