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COMPLETED
NCT06115304
EARLY_PHASE1

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

Sponsor: Mikkel Bring Christensen

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

50 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-10-05

Completion Date

2024-08-26

Last Updated

2026-10-23

Healthy Volunteers

Yes

Interventions

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) and Caffeine (to prevent postspinal headache). 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 (1)

Deparrtment of clinical pharmacology

Copenhagen, Denmark