Bariatric Surgery (Gastric Bypass), Overweight
Conditions
Keywords
Glucagon-like Peptide-1, Glucose-dependent insulinotropic peptide, Glucagon, Peptide YY 3-36, Ghrelin, Body Weight, Obesity, Overnutrition, Overweight, Gastrointestinal Agents, GLP-1 secretagogue
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.
Interventions
OTHERMealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes
OTHERMealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes
OTHERMealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes
OTHERMealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes
Sponsors
University of Copenhagen
Kirstine Nyvold Bojsen-Moeller
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Within group difference in Glucagon 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 Cholecystokinin secretion (evaluated by iAUC). | Basline, 0, 15, 30, 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 Ghrelin secretion (evaluated by iAUC). | 0, 30, 45, 60, 120, 180, 240 | — |
| Within group difference in Changes in bile acids. | 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 Plasma glucose concentration. | 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 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 Ad libitum food intake (grams). | 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 Blood pressure (mmhg). | 0, 15, 30, 45, 60, 90, 120, 180, 240 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Between groups 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 Gastric bypass operated patients and Healthy volunteers. |
| Between groups difference in Glucagon secretion (evaluated by iAUC). | Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 | — |
| Between groups difference in Glucose-dependent insulinotropic peptide secretion (evaluated by iAUC). | Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 | — |
| Between groups difference in Cholecystokinin secretion (evaluated by iAUC). | Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 | — |
| Between groups difference in Peptide YY 3-36 secretion (evaluated by iAUC). | Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 | — |
| Between groups difference in Ghrelin secretion (evaluated by iAUC). | 0, 30, 45, 60, 120, 180, 240 | — |
| Between groups difference in Changes in bile acids. | 0, 30, 45, 60, 120, 180, 240 | — |
| Between groups difference in Changes in glycerol, triacylglycerol and free fatty acids. | 0, 30, 45, 60, 120, 180, 240 | — |
| Between groups difference in Insulin secretion (evaluated by iAUC). | 2xBasline, 0, 10, 15, 20, 30, 40, 45, 60, 90, 120, 180, 240 | — |
| Between groups difference in Plasma glucose concentration. | 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240 | — |
| Between groups 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 |
| Between groups difference in Ad libitum food intake (grams). | 240 | — |
| Between groups difference in Heart rate (bpm). | 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240 | — |
| Between groups difference in Blood pressure (mmhg). | 0, 15, 30, 45, 60, 90, 120, 180, 240 | — |
Countries
Denmark
Outcome results
None listed