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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115304
• Other study ID #: CSF-meal
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2023
• Est. completion date: October 10, 2024

Study information

• Verified date: October 2023
• Source: Bispebjerg Hospital
• Contact: Mikkel B Christensen, MD, PhD
• Phone: +4538635102
• Email: Mikkel.bring.christensen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 10, 2024
• Est. primary completion date: October 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity

Intervention

Other:
• Large liquid meal, spinal catheter and venous line
Large liquid meal (e.g. Nutricia® Energy 500 ml (750 kcal) admixed paracetamol 1000 mg (for estimation of gastric emptying). Spinal catheter for 4 hours, with samples taken at one hour interval. 2 venous lines, one for saline and one for venous sampling every half hour

Locations

Country	Name	City	State
Denmark	Deparrtment of clinical pharmacology	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Mikkel Bring Christensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry		After 1 hour
Other	Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry		After 2 hours
Other	Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry		After 3 hours
Other	Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry		After 4 hours
Other	Proteomics measured in blood and cerebrospinalfluid using mass spectrometry		After 1 hour
Other	Proteomics measured in blood and cerebrospinalfluid using mass spectrometry		After 2 hours
Other	Proteomics measured in blood and cerebrospinalfluid using mass spectrometry		After 3 hours
Other	Proteomics measured in blood and cerebrospinalfluid using mass spectrometry		After 4 hours
Other	Peptidomics measured in blood and cerebrospinalfluid using mass spectrometry		After 1 hour
Other	Peptidomics measured in blood and cerebrospinalfluid using mass spectrometry		After 2 hour
Other	Peptidomics measured in blood and cerebrospinalfluid using mass spectrometry		After 3 hours
Other	Peptidomicsmeasured in blood and cerebrospinalfluid using mass spectrometry		After 4 hours
Primary	Appetite regulating hormones measured by specific immunoassays		After 1 hour
Primary	Appetite regulating hormones measured by specific immunoassays		After 2 hour
Primary	Appetite regulating hormones measured by specific immunoassays		After 3 hours
Primary	Appetite regulating hormones measured by specific immunoassays		After 4 hours