Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet?

Bariatric Surgery (Gastric Bypass) Clinical Trial

Official title:

Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665715
• Other study ID #: DK-REAKTIV-15
• Status: Completed
• Phase: N/A
• First received: January 25, 2016
• Last updated: July 20, 2016
• Start date: August 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

Roux-en-Y gastric bypass (RYGB) accelerates nutrient delivery to the small intestine causing higher peak blood glucose concentration early after meal intake. In the late postprandial period (1 1⁄2-2 h) nadir blood glucose level is lower compared with before operation. In some patients, overt postprandial hypoglycaemia develops, and is typically reported as a complication 1-5 years postoperatively, when maximal weight loss has been obtained. The pathophysiology of postprandial hypoglycaemia involves inappropriate hyper-secretion of insulin associated with exaggerated secretion of the gut hormone glucagon-like peptide-1 (GLP-1) leading to a mismatch between glucose absorption rate, insulin secretion and whole body glucose disposal. We hypothesize that lowering carbohydrate content of meals reduces postprandial glucose excursions whereby GLP-1 and insulin secretion is reduced and reactive hypoglycemia prevented.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• RYGB operated patients more than 12 month after operation

• Stable in weight for at least 3 months (+/- 3 kg)

• Plasma glucose below 3.4 mmol/L after screening with test meal (Fresubin drink) or with continuous glucose monitoring

Exclusion Criteria:

• Fasting plasma glucose concentration > 7mmol/L

• Critical illness

• Hgb < 6.5 mM

• Pregnancy or breastfeeding

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bariatric Surgery (Gastric Bypass)
• Hypoglycemia

Intervention

Other:
• Low carbohydrate meals
Meal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40%
• Standard carbohydrate meals
Meal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30%

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Amirsalar Samkani	Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nadir plasma glucose	Between low carbohydrate meal and standard meal.	0-240 min, 240-480 min	No
Secondary	Peak plasma glucose	Between low carbohydrate meal and standard meal.	0-240 min, 240-480 min	No
Secondary	Time to nadir glucose	Between low carbohydrate meal and standard meal.	0-240 min, 240-480 min	No
Secondary	Time to peak glucose	Between low carbohydrate meal and standard meal.	0-240 min, 240-480 min	No
Secondary	Postprandial incremental glucose area	Between low carbohydrate meal and standard meal.	0-240 min, 240-480 min	No
Secondary	Postprandial decremental glucose area	Between low carbohydrate meal and standard meal.	0-240 min, 240-480 min	No
Secondary	Postprandial incremental insulin area	Between low carbohydrate meal and standard meal.	0-240 min, 240-480 min	No
Secondary	Postprandial incremental GLP-1 area	Between low carbohydrate meal and standard meal.	0-240 min, 240-480 min	No
Secondary	Time below basline glucose concentrations	Between low carbohydrate meal and standard meal.	0-480 min	No
Secondary	Glycemic excursions	Between low carbohydrate meal and standard meal.	0-480 min	No