Clinical trial NCT02372526: The Effect of Different Macronutrients on Gastrointestinal Hormone Secretion After Gastric Bypass Operation
Official title: The Effect of Different Macronutrients on Gastrointestinal Hormone Secretion After Gastric Bypass Operation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bariatric Surgery (Gastric Bypass)
Overweight
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
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2015-02-26
Enrollment: 18
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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.

Primary outcomes:
measure: Within group difference in Glucagon-like Peptide 1 secretion (evaluated by iAUC).
timeFrame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Secondary outcomes:
measure: Within group difference in Glucagon secretion (evaluated by iAUC).
timeFrame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
measure: Within group difference in Glucose-dependent insulinotropic peptide secretion (evaluated by iAUC).
timeFrame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
measure: Within group difference in Cholecystokinin secretion (evaluated by iAUC).
timeFrame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
measure: Within group difference in Peptide YY 3-36 secretion (evaluated by iAUC).
timeFrame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
measure: Within group difference in Ghrelin secretion (evaluated by iAUC).
timeFrame: 0, 30, 45, 60, 120, 180, 240
measure: Within group difference in Changes in bile acids.
timeFrame: 0, 30, 45, 60, 120, 180, 240
measure: Within group difference in Changes in glycerol, triacylglycerol and free fatty acids.
timeFrame: 0, 30, 45, 60, 120, 180, 240
measure: Within group difference in Insulin secretion (evaluated by iAUC).
timeFrame: 2xBasline, 0, 10, 15, 20, 30, 40, 45, 60, 90, 120, 180, 240
measure: Within group difference in Plasma glucose concentration.
timeFrame: 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240
measure: Within group difference in Visual Analog Scale.
timeFrame: 0, 30, 60, 90, 120, 180, 240
measure: Within group difference in Ad libitum food intake (grams).
timeFrame: 240
measure: Within group difference in Heart rate (bpm).
timeFrame: 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240
measure: Within group difference in Blood pressure (mmhg).
timeFrame: 0, 15, 30, 45, 60, 90, 120, 180, 240
Other outcomes:
measure: Between groups difference in Glucagon-like Peptide 1 secretion (evaluated by iAUC).
timeFrame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
measure: Between groups difference in Glucagon secretion (evaluated by iAUC).
timeFrame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
measure: Between groups difference in Glucose-dependent insulinotropic peptide secretion (evaluated by iAUC).
timeFrame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
measure: Between groups difference in Cholecystokinin secretion (evaluated by iAUC).
timeFrame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
measure: Between groups difference in Peptide YY 3-36 secretion (evaluated by iAUC).
timeFrame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
measure: Between groups difference in Ghrelin secretion (evaluated by iAUC).
timeFrame: 0, 30, 45, 60, 120, 180, 240
measure: Between groups difference in Changes in bile acids.
timeFrame: 0, 30, 45, 60, 120, 180, 240
measure: Between groups difference in Changes in glycerol, triacylglycerol and free fatty acids.
timeFrame: 0, 30, 45, 60, 120, 180, 240
measure: Between groups difference in Insulin secretion (evaluated by iAUC).
timeFrame: 2xBasline, 0, 10, 15, 20, 30, 40, 45, 60, 90, 120, 180, 240
measure: Between groups difference in Plasma glucose concentration.
timeFrame: 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240
measure: Between groups difference in Visual Analog Scale.
timeFrame: 0, 30, 60, 90, 120, 180, 240
measure: Between groups difference in Ad libitum food intake (grams).
timeFrame: 240
measure: Between groups difference in Heart rate (bpm).
timeFrame: 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240
measure: Between groups difference in Blood pressure (mmhg).
timeFrame: 0, 15, 30, 45, 60, 90, 120, 180, 240
Locations:
city: Hvidovre
country: Denmark
facility: Endocrinology Research Center, Hvidovre University Hospital
state: Copenhagen
Study officials:
References: