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

NCT06115304 | Unknown

• 1 other identifier: CSF-meal
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Obesity; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

• Appetite regulating hormones measured by specific immunoassays

  After 1 hour

• Appetite regulating hormones measured by specific immunoassays

  After 2 hour

• Appetite regulating hormones measured by specific immunoassays

  After 3 hours

• Appetite regulating hormones measured by specific immunoassays

  After 4 hours

Other Outcomes (12)

• Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry

  After 1 hour

• Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry

  After 2 hours

• Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry

  After 3 hours

Study Arms (1)

Intervention arm

OTHER

Other: Large liquid meal, spinal catheter and venous line

Interventions

Large liquid meal, spinal catheter and venous line OTHER

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

Intervention arm

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male patients with obesity (BMI \>30) and type 2 diabetes
• male volunteers with normal weight (BMI 20-24) matched by age
• male volunteers with obesity (BMI \>30) matched by age

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mikkel Bring Christensen: lead

Study Sites (1)

Deparrtment of clinical pharmacology

Copenhagen, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mikkel.bring.christensen@regionh.dk B Christensen, MD, PhD

  Department of clinical pharmacology, Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikkel B Christensen, MD, PhD

CONTACT

+4538635102; Mikkel.bring.christensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief consultent at the department of Clinical Pharmacology

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 3, 2023
• Study Start: October 5, 2023
• Primary Completion: October 5, 2024
• Study Completion: October 10, 2024
• Last Updated: November 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)