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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02372526
Date of registration:	20/02/2015
Prospective Registration:	No
Primary sponsor:	Kirstine Nyvold Bojsen-Moeller
Public title:	The Effect of Different Macronutrients on Gastrointestinal Hormone Secretion After Gastric Bypass Operation
Scientific title:	The Effect of Different Macronutrients on Gastrointestinal Hormone Secretion After Gastric Bypass Operation
Date of first enrolment:	January 2015
Target sample size:	18
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/show/NCT02372526
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Denmark

Contacts

Key inclusion & 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.

Age minimum: 25 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Overweight

Bariatric Surgery (Gastric Bypass)

Intervention(s)

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

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

Primary Outcome(s)

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

Secondary Outcome(s)

Within group difference in Changes in glycerol, triacylglycerol and free fatty acids. [Time Frame: 0, 30, 45, 60, 120, 180, 240]

Within group difference in Peptide YY 3-36 secretion (evaluated by iAUC). [Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240]

Within group difference in Ad libitum food intake (grams). [Time Frame: 240]

Within group difference in Glucagon secretion (evaluated by iAUC). [Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240]

Within group difference in Insulin secretion (evaluated by iAUC). [Time Frame: 2xBasline, 0, 10, 15, 20, 30, 40, 45, 60, 90, 120, 180, 240]

Within group difference in Changes in bile acids. [Time Frame: 0, 30, 45, 60, 120, 180, 240]

Within group difference in Heart rate (bpm). [Time Frame: 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240]

Within group difference in Ghrelin secretion (evaluated by iAUC). [Time Frame: 0, 30, 45, 60, 120, 180, 240]

Within group difference in Plasma glucose concentration. [Time Frame: 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240]

Within group difference in Visual Analog Scale. [Time Frame: 0, 30, 60, 90, 120, 180, 240]

Within group difference in Blood pressure (mmhg). [Time Frame: 0, 15, 30, 45, 60, 90, 120, 180, 240]

Within group difference in Cholecystokinin secretion (evaluated by iAUC). [Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240]

Within group difference in Glucose-dependent insulinotropic peptide secretion (evaluated by iAUC). [Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240]

Secondary ID(s)

CZJ-MA-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Copenhagen

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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