The Effect of Different Macronutrients on Gastrointestinal Hormone Secretion After Gastric Bypass Operation

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.

Study Overview

• Status: Unknown
• Conditions: Overweight; Bariatric Surgery (Gastric Bypass)
• Intervention / Treatment: Other: 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

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Hvidovre, Copenhagen, Denmark, 2650
      • Endocrinology Research Center, Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

RYGB Patients who have underwent RYGB surgery more than 18 months earlier, weight stabile (+/- 5 kg during 1 month). Healthy control subjects who have not underwent bariatric surgery.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
10 Roux-en-Y gastric bypass patients; Isocaloric amounts of specific macronutrients is mixed with 4 g vegetable bouillon and tested against each others ability to induce GLP-1 secretion. The mealtest takes place at 4 different days with 3-14 days separation.	Other: Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes; Other Names: LACPRODAN SP-9225 INSTANT Whey Protein Isolate; Other: Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes; Other Names: Lurpak® smør(butter) 81% fat; Other: Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes; Other Names: Urtegaarden Druesukker (Dextrose monohydrat); Other: Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes; Other Names: Lurpak® smør(butter) 81% fat with 120 mg Xenical® Orlistat
10 Healthy Control subjects; Isocaloric amounts of specific macronutrients is mixed with 4 g vegetable bouillon and tested against each others ability to induce GLP-1 secretion. The mealtest takes place at 4 different days with 3-14 days separation.	Other: Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes; Other Names: LACPRODAN SP-9225 INSTANT Whey Protein Isolate; Other: Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes; Other Names: Lurpak® smør(butter) 81% fat; Other: Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes; Other Names: Urtegaarden Druesukker (Dextrose monohydrat); Other: Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes; Other Names: Lurpak® smør(butter) 81% fat with 120 mg Xenical® Orlistat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Within group difference in Glucagon-like Peptide 1 secretion (evaluated by iAUC).	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.	Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Hunger, satiety, abdominal pain and nausea measured by standard 10 cm Visual Analog Scale	0, 30, 60, 90, 120, 180, 240
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between groups difference in Glucagon-like Peptide 1 secretion (evaluated by iAUC).	I.e. Comparison of GLP-1 secretion (iAUC) as a result of intake of different macronutrients between Gastric bypass operated patients and Healthy volunteers.	Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
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.	Hunger, satiety, abdominal pain and nausea measured by standard 10 cm Visual Analog Scale	0, 30, 60, 90, 120, 180, 240
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

Collaborators and Investigators

• Sponsor: Kirstine Nyvold Bojsen-Moeller
• Collaborators: University of Copenhagen

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: February 20, 2015
• First Submitted That Met QC Criteria: February 20, 2015
• First Posted (Estimate): February 26, 2015

Study Record Updates

• Last Update Posted (Estimate): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Body Weight; Glucagon; Overnutrition; Ghrelin; Gastrointestinal Agents; Glucagon-like Peptide-1; Glucose-dependent insulinotropic peptide; Peptide YY 3-36; GLP-1 secretagogue
• Additional Relevant MeSH Terms: Body Weight; Overweight; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Lipid Regulating Agents; Anti-Obesity Agents; Orlistat
• Other Study ID Numbers: CZJ-MA-14