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

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery (Gastric Bypass)
• Intervention / Treatment: Other: Low carbohydrate meals; Other: Standard carbohydrate meals

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Hvidovre, Copenhagen, Denmark, 2650
      • Endocrinology Research Center, Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low carbohydrate/Standard carbohydrate; 10 Roux-en-Y gastric bypass operated subjects are tested two days with mixed-meal tests. Each studytest day consist of both breakfast and lunch.	Other: Low carbohydrate meals; Meal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40%; Other: Standard carbohydrate meals; Meal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30%
Experimental: Standard carbohydrate/Low carbohydrate; 10 Roux-en-Y gastric bypass operated subjects are tested two days with mixed-meal tests. Each studytest day consist of both breakfast and lunch.	Other: Low carbohydrate meals; Meal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40%; Other: Standard carbohydrate meals; Meal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nadir plasma glucose	Between low carbohydrate meal and standard meal.	0-240 min, 240-480 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak plasma glucose	Between low carbohydrate meal and standard meal.	0-240 min, 240-480 min
Time to nadir glucose	Between low carbohydrate meal and standard meal.	0-240 min, 240-480 min
Time to peak glucose	Between low carbohydrate meal and standard meal.	0-240 min, 240-480 min
Postprandial incremental glucose area	Between low carbohydrate meal and standard meal.	0-240 min, 240-480 min
Postprandial decremental glucose area	Between low carbohydrate meal and standard meal.	0-240 min, 240-480 min
Postprandial incremental insulin area	Between low carbohydrate meal and standard meal.	0-240 min, 240-480 min
Postprandial incremental GLP-1 area	Between low carbohydrate meal and standard meal.	0-240 min, 240-480 min
Time below basline glucose concentrations	Between low carbohydrate meal and standard meal.	0-480 min
Glycemic excursions	Between low carbohydrate meal and standard meal.	0-480 min

Collaborators and Investigators

• Sponsor: Amirsalar Samkani
• Collaborators: Hvidovre University Hospital
• Investigators: Principal Investigator: Kirstine Bojsen-Moller, MD, Postdoc, Hvidovre University Hospital; Principal Investigator: Sten Madsbad, MD, Prof, Hvidovre University Hospital

Publications and helpful links

General Publications

• Kandel D, Bojsen-Moller KN, Svane MS, Samkani A, Astrup A, Holst JJ, Madsbad S, Krarup T. Mechanisms of action of a carbohydrate-reduced, high-protein diet in reducing the risk of postprandial hypoglycemia after Roux-en-Y gastric bypass surgery. Am J Clin Nutr. 2019 Aug 1;110(2):296-304. doi: 10.1093/ajcn/nqy310.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: January 25, 2016
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimate): January 28, 2016

Study Record Updates

• Last Update Posted (Estimate): July 21, 2016
• Last Update Submitted That Met QC Criteria: July 20, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Diet; Glucagon; Ghrelin; Hyperinsulinaemia; Peptide YY; Glucagon-like Peptide-1; Reactive hypoglycemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: DK-REAKTIV-15