NCT06115304CompletedEarly phase 1
Postprandial Profiles of Metabolites and Appetite-regulating Hormones in Plasma and Cerebrospinal Fluid
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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 disorders. Therapeutic strategies against obesity - which include an abundance of dietary and physical training programmes and pharmaceutical drugs to increase energy expenditure or limit appetite or gastro-intestinal fat absorption - have shown limited success on long term weight loss. Thus, overweight and associated conditions is becoming the new normal and there is a need for better understanding gut-to-brain signalling, hormonal and metabolic disturbances in overweight individuals. The purpose of this health science research project is to describe the coinciding plasma and cerebrospinal fluid (CSF) profiles of selected biomarkers after co-ingestion of a meal and model pharmaceuticals in patients with overweight and/or type 2 diabetes compared to healthy control individuals.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 25 Oct 2023
- Start date
- 5 Oct 2023
- Primary completion date
- 26 Aug 2024
- Lead sponsor
- Mikkel Bring Christensen
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06115304
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 24
- From 5 Oct 2023 to the primary completion date, 26 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anticoagulant treatment (e.g. treatment with warfarin, apixaban or another oral anticoagulant)
- 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)
- Central nervous system disease (including dementia, previous stroke, multiple sclerosis, epilepsy, 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)
Other illness
- Lumbar skin infection (e.g. herpes zoster, pustules or ulcers)
Lab values
- Hepatic disease or hemorrhagic diatheses (including abnormal International Normalized Ratio (INR), bilirubin, blood levels of thrombocytes, alanine-aminotransferase (ALAT))
- Anaemia (p-hemoglobin below normal range)
- Nephropathy (se-creatinine \>130 μM and/or albuminuria)
Other
- Unwillingness to participate or wish to withdraw from ongoing protocol
- Medical history with headaches - both in connection with dura puncture and frequent headaches of other types
- Clinical suspicion of increased intracranial pressure (headaches, visual disturbances etc.)
Who the study is looking for
- 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
Age in the registry: 50 years to 70 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Deparrtment of clinical pharmacology Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.