The Effect of Different Macronutrients on Gastrointestinal Hormone Secretion After Gastric Bypass Operation
- Conditions
- Bariatric Surgery (Gastric Bypass)Overweight
- Registration Number
- NCT02372526
- Lead Sponsor
- Kirstine Nyvold Bojsen-Moeller
- Brief Summary
The purpose of this study is to determine the type of macronutrient (carbohydrate, lipid or protein) that most potently stimulates the endogen secretion of different gut hormones (primary outcome = Glucagon-Like peptide-1) in gastric bypass operated patients. The study also includes a comparison of the secretion of gut hormones after oral intake of lipid with or without a pancreatic lipase inhibitor.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 18
- Underwent RYGB surgery more than 18 months earlier, weight stabile (+/- 5 kg during 1 month)
- Inadequate thyroid substitution, undergoing treatment with drugs known to interact with Orlistat (such as cyclosporine, anticoagulating agents, amiodarone, amlodipine and epileptics), where pausing the treatment with these is not an option. Type 1 or 2 diabetes mellitus now or prior to RYGB operation. Serious heart or respiratory illness. Haemoglobin levels below 6,5 mM.
Healthy control subjects:
Inclusion Criteria:
- Have not underwent bariatric surgery.
Exclusion Criteria:
- Inadequate thyroid substitution, undergoing treatment with drugs known to interact with Orlistat (such as cyclosporine, anticoagulating agents, amiodarone, amlodipine and epileptics), where pausing the treatment with these is not an option. Type 1 or 2 diabetes mellitus now or prior. Serious heart or respiratory illness. Haemoglobin levels below 6,5 mM.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Within group difference in Glucagon-like Peptide 1 secretion (evaluated by iAUC). Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 I.e. Comparison of GLP-1 secretion (iAUC) as a result of intake of different macronutrients between a) gastric bypass patients only b) healthy volunteers only.
- Secondary Outcome Measures
Name Time Method Within group difference in Glucagon secretion (evaluated by iAUC). Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 Within group difference in Cholecystokinin secretion (evaluated by iAUC). Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 Within group difference in Changes in bile acids. 0, 30, 45, 60, 120, 180, 240 Within group difference in Visual Analog Scale. 0, 30, 60, 90, 120, 180, 240 Hunger, satiety, abdominal pain and nausea measured by standard 10 cm Visual Analog Scale
Within group difference in Ghrelin secretion (evaluated by iAUC). 0, 30, 45, 60, 120, 180, 240 Within group difference in Changes in glycerol, triacylglycerol and free fatty acids. 0, 30, 45, 60, 120, 180, 240 Within group difference in Insulin secretion (evaluated by iAUC). 2xBasline, 0, 10, 15, 20, 30, 40, 45, 60, 90, 120, 180, 240 Within group difference in Heart rate (bpm). 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240 Within group difference in Peptide YY 3-36 secretion (evaluated by iAUC). Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 Within group difference in Glucose-dependent insulinotropic peptide secretion (evaluated by iAUC). Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 Within group difference in Blood pressure (mmhg). 0, 15, 30, 45, 60, 90, 120, 180, 240 Within group difference in Plasma glucose concentration. 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240 Within group difference in Ad libitum food intake (grams). 240
Trial Locations
- Locations (1)
Endocrinology Research Center, Hvidovre University Hospital
🇩🇰Hvidovre, Copenhagen, Denmark