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Life sciences · Phase EARLY_PHASE1 Trial
ClinicalTrials.gov · October 23, 2026
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Phase EARLY_PHASE1 Trial.
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Registry record from ClinicalTrials.gov (NCT06115304). This is a study registration, not published results. Lead sponsor: Mikkel Bring Christensen. Recruitment status: COMPLETED. Phase: EARLY_PHASE1. Study type: INTERVENTIONAL. Enrollment: 24 participants (ACTUAL). Conditions: Obesity, Diabetes Mellitus, Type 2. Interventions: OTHER: Large liquid meal, spinal catheter and venous line. Primary outcome measures: 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. 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.