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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02372526
• Other study ID #: CZJ-MA-14
• Status: Active, not recruiting
• Phase: N/A
• First received: February 20, 2015
• Last updated: February 6, 2017
• Start date: January 2015
• Est. completion date: June 2017

Study information

• Verified date: February 2017
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: June 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery (Gastric Bypass)
• Overweight

Intervention

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

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

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

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

Locations

Country	Name	City	State
Denmark	Endocrinology Research Center, Hvidovre University Hospital	Hvidovre	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Kirstine Nyvold Bojsen-Moeller	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Between groups difference in Glucagon secretion (evaluated by iAUC).		Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Other	Between groups difference in Glucose-dependent insulinotropic peptide secretion (evaluated by iAUC).		Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Other	Between groups difference in Cholecystokinin secretion (evaluated by iAUC).		Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Other	Between groups difference in Peptide YY 3-36 secretion (evaluated by iAUC).		Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Other	Between groups difference in Ghrelin secretion (evaluated by iAUC).		0, 30, 45, 60, 120, 180, 240
Other	Between groups difference in Changes in bile acids.		0, 30, 45, 60, 120, 180, 240
Other	Between groups difference in Changes in glycerol, triacylglycerol and free fatty acids.		0, 30, 45, 60, 120, 180, 240
Other	Between groups difference in Insulin secretion (evaluated by iAUC).		2xBasline, 0, 10, 15, 20, 30, 40, 45, 60, 90, 120, 180, 240
Other	Between groups difference in Plasma glucose concentration.		2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240
Other	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
Other	Between groups difference in Ad libitum food intake (grams).		240
Other	Between groups difference in Heart rate (bpm).		2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240
Other	Between groups difference in Blood pressure (mmhg).		0, 15, 30, 45, 60, 90, 120, 180, 240
Primary	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	Within group difference in Glucagon secretion (evaluated by iAUC).		Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Secondary	Within group difference in Glucose-dependent insulinotropic peptide secretion (evaluated by iAUC).		Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Secondary	Within group difference in Cholecystokinin secretion (evaluated by iAUC).		Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Secondary	Within group difference in Peptide YY 3-36 secretion (evaluated by iAUC).		Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Secondary	Within group difference in Ghrelin secretion (evaluated by iAUC).		0, 30, 45, 60, 120, 180, 240
Secondary	Within group difference in Changes in bile acids.		0, 30, 45, 60, 120, 180, 240
Secondary	Within group difference in Changes in glycerol, triacylglycerol and free fatty acids.		0, 30, 45, 60, 120, 180, 240
Secondary	Within group difference in Insulin secretion (evaluated by iAUC).		2xBasline, 0, 10, 15, 20, 30, 40, 45, 60, 90, 120, 180, 240
Secondary	Within group difference in Plasma glucose concentration.		2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240
Secondary	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
Secondary	Within group difference in Ad libitum food intake (grams).		240
Secondary	Within group difference in Heart rate (bpm).		2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240
Secondary	Within group difference in Blood pressure (mmhg).		0, 15, 30, 45, 60, 90, 120, 180, 240