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

• Sponsor: Mikkel Bring Christensen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06115304
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12.2
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Diabetes Mellitus, Type 2	Other: Large liquid meal, spinal catheter and venous line	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Postprandial Profiles of Metabolites and Appetite-regulating Hormones in Plasma and Cerebrospinal Fluid
• Actual Study Start Date: Oct 5, 2023
• Anticipated Primary Completion Date: Oct 5, 2024
• Anticipated Study Completion Date: Oct 10, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Intervention arm	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

Outcome Measures

Primary Outcome Measures

1. Appetite regulating hormones measured by specific immunoassays [After 1 hour]

2. Appetite regulating hormones measured by specific immunoassays [After 2 hour]

3. Appetite regulating hormones measured by specific immunoassays [After 3 hours]

4. Appetite regulating hormones measured by specific immunoassays [After 4 hours]

Other Outcome Measures

1. Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry [After 1 hour]

2. Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry [After 2 hours]

3. Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry [After 3 hours]

4. Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry [After 4 hours]

5. Proteomics measured in blood and cerebrospinalfluid using mass spectrometry [After 1 hour]

6. Proteomics measured in blood and cerebrospinalfluid using mass spectrometry [After 2 hours]

7. Proteomics measured in blood and cerebrospinalfluid using mass spectrometry [After 3 hours]

8. Proteomics measured in blood and cerebrospinalfluid using mass spectrometry [After 4 hours]

9. Peptidomics measured in blood and cerebrospinalfluid using mass spectrometry [After 1 hour]

10. Peptidomics measured in blood and cerebrospinalfluid using mass spectrometry [After 2 hour]

11. Peptidomics measured in blood and cerebrospinalfluid using mass spectrometry [After 3 hours]

12. Peptidomicsmeasured in blood and cerebrospinalfluid using mass spectrometry [After 4 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Deparrtment of clinical pharmacology	Copenhagen		Denmark	2400

Sponsors and Collaborators

• Mikkel Bring Christensen

Investigators

• Principal Investigator: [e-mail] B Christensen, MD, PhD, Department of clinical pharmacology, Bispebjerg Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mikkel Bring Christensen, Chief consultent at the department of Clinical Pharmacology, Bispebjerg Hospital
• ClinicalTrials.gov Identifier: NCT06115304
• Other Study ID Numbers: CSF-meal
• First Posted: Nov 3, 2023
• Last Update Posted: Nov 3, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Nov 3, 2023