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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry | After 1 hour | |
| Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry | After 2 hours | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mikkel B Christensen, MD, PhD | Contact | +4538635102 | Mikkel.bring.christensen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Mikkel.bring.christensen@regionh.dk B Christensen, MD, PhD | Department of clinical pharmacology, Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deparrtment of clinical pharmacology | Recruiting | Copenhagen | 2400 | Denmark |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry |
| After 3 hours |
| Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry | After 4 hours |
| Proteomics measured in blood and cerebrospinalfluid using mass spectrometry | After 1 hour |
| Proteomics measured in blood and cerebrospinalfluid using mass spectrometry | After 2 hours |
| Proteomics measured in blood and cerebrospinalfluid using mass spectrometry | After 3 hours |
| Proteomics measured in blood and cerebrospinalfluid using mass spectrometry | After 4 hours |
| Peptidomics measured in blood and cerebrospinalfluid using mass spectrometry | After 1 hour |
| Peptidomics measured in blood and cerebrospinalfluid using mass spectrometry | After 2 hour |
| Peptidomics measured in blood and cerebrospinalfluid using mass spectrometry | After 3 hours |
| Peptidomicsmeasured in blood and cerebrospinalfluid using mass spectrometry | After 4 hours |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |