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

K

Kirstine Nyvold Bojsen-Moeller

Status

Unknown

Conditions

Overweight
Bariatric Surgery (Gastric Bypass)

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT02372526
CZJ-MA-14

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

25 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

18 participants in 2 patient groups

10 Roux-en-Y gastric bypass patients
Description:
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.
Treatment:
Other: Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes
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 fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes
10 Healthy Control subjects
Description:
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.
Treatment:
Other: Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes
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 fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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