The Effect of Different Macronutrients on Gastrointestinal Hormone Secretion After Gastric Bypass Operation
Information source: Hvidovre University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bariatric Surgery (Gastric Bypass); Overweight
Intervention: Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes (Other); Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes (Other); Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes (Other); Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Kirstine Nyvold Bojsen-Moeller Overall contact:
Kirstine Bojsen-Møller, MD, Postdoc, Phone: +4538626371, Email: Bojsen-Moeller@regionh.dk
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.
Clinical Details
Official title: The Effect of Different Macronutrients on Gastrointestinal Hormone Secretion After Gastric Bypass Operation
Study design: Observational Model: Case Control, Time Perspective: Cross-Sectional
Primary outcome: Within group difference in Glucagon-like Peptide 1 secretion (evaluated by iAUC).
Secondary outcome: Within group difference in Glucagon secretion (evaluated by iAUC).Within group difference in Glucose-dependent insulinotropic peptide secretion (evaluated by iAUC). Within group difference in Cholecystokinin secretion (evaluated by iAUC). Within group difference in Peptide YY 3-36 secretion (evaluated by iAUC). Within group difference in Ghrelin secretion (evaluated by iAUC). Within group difference in Changes in bile acids. Within group difference in Changes in glycerol, triacylglycerol and free fatty acids. Within group difference in Insulin secretion (evaluated by iAUC). Within group difference in Plasma glucose concentration. Within group difference in Visual Analog Scale. Within group difference in Ad libitum food intake (grams). Within group difference in Heart rate (bpm). Within group difference in Blood pressure (mmhg).
Eligibility
Minimum age: 25 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
RYGB Patients:
Inclusion Criteria:
- Underwent RYGB surgery more than 18 months earlier, weight stabile (+/- 5 kg during 1
month)
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 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.
Locations and Contacts
Kirstine Bojsen-Møller, MD, Postdoc, Phone: +4538626371, Email: Bojsen-Moeller@regionh.dk
Endocrinology Research Center, Hvidovre University Hospital, Hvidovre, Copenhagen 2650, Denmark; Recruiting
Kirstine Bojsen-Møller, MD, Postdoc, Phone: +4538626371, Email: Bojsen-Moeller@regionh.dk
Sten Madsbad, MD, DMSc
Additional Information
Starting date: January 2015
Last updated: February 20, 2015
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