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

NCT ID: NCT02372526

Last Updated: 2017-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Bariatric Surgery (Gastric Bypass) Overweight

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes

Intervention Type OTHER

Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes

Intervention Type OTHER

Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes

Intervention Type OTHER

Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes

Intervention Type OTHER

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.

Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes

Intervention Type OTHER

Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes

Intervention Type OTHER

Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes

Intervention Type OTHER

Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes

Intervention Type OTHER

Interventions

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Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes

Intervention Type OTHER

Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes

Intervention Type OTHER

Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes

Intervention Type OTHER

Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes

Intervention Type OTHER

Other Intervention Names

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LACPRODAN SP-9225 INSTANT Whey Protein Isolate Lurpak® smør(butter) 81% fat Urtegaarden Druesukker (Dextrose monohydrat) Lurpak® smør(butter) 81% fat with 120 mg Xenical® Orlistat

Eligibility Criteria

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Inclusion Criteria

* Underwent RYGB surgery more than 18 months earlier, weight stabile (+/- 5 kg during 1 month)


* 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 to RYGB operation. Serious heart or respiratory illness. Haemoglobin levels below 6,5 mM.

Healthy control subjects:


* 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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Kirstine Nyvold Bojsen-Moeller

OTHER

Sponsor Role lead

Responsible Party

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Kirstine Nyvold Bojsen-Moeller

Postdoc

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Endocrinology Research Center, Hvidovre University Hospital

Hvidovre, Copenhagen, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CZJ-MA-14

Identifier Type: -

Identifier Source: org_study_id

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