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

• Sponsor: Amirsalar Samkani (Other)
• Overall Status: Completed
• CT.gov ID: NCT02665715
• Collaborator: Hvidovre University Hospital (Other)
• Enrollment: 10
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bariatric Surgery (Gastric Bypass)	Other: Low carbohydrate meals; Other: Standard carbohydrate meals	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet?
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

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%

Outcome Measures

Primary Outcome Measures

1. Nadir plasma glucose [0-240 min, 240-480 min]

   Between low carbohydrate meal and standard meal.

Secondary Outcome Measures

1. Peak plasma glucose [0-240 min, 240-480 min]

   Between low carbohydrate meal and standard meal.

2. Time to nadir glucose [0-240 min, 240-480 min]

   Between low carbohydrate meal and standard meal.

3. Time to peak glucose [0-240 min, 240-480 min]

   Between low carbohydrate meal and standard meal.

4. Postprandial incremental glucose area [0-240 min, 240-480 min]

   Between low carbohydrate meal and standard meal.

5. Postprandial decremental glucose area [0-240 min, 240-480 min]

   Between low carbohydrate meal and standard meal.

6. Postprandial incremental insulin area [0-240 min, 240-480 min]

   Between low carbohydrate meal and standard meal.

7. Postprandial incremental GLP-1 area [0-240 min, 240-480 min]

   Between low carbohydrate meal and standard meal.

8. Time below basline glucose concentrations [0-480 min]

   Between low carbohydrate meal and standard meal.

9. Glycemic excursions [0-480 min]

   Between low carbohydrate meal and standard meal.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Endocrinology Research Center, Hvidovre University Hospital	Hvidovre	Copenhagen	Denmark	2650

Sponsors and Collaborators

• Amirsalar Samkani
• Hvidovre University Hospital

Investigators

• Principal Investigator: Kirstine Bojsen-Moller, MD, Postdoc, Hvidovre University Hospital
• Principal Investigator: Sten Madsbad, MD, Prof, Hvidovre University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amirsalar Samkani, PhD-Student, Bispebjerg Hospital
• ClinicalTrials.gov Identifier: NCT02665715
• Other Study ID Numbers: DK-REAKTIV-15
• First Posted: Jan 28, 2016
• Last Update Posted: Jul 21, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by Amirsalar Samkani, PhD-Student, Bispebjerg Hospital: Reactive hypoglycemia; Hyperinsulinaemia; Diet; Glucagon-like Peptide-1; Glucagon; Peptide YY; Ghrelin
• Additional relevant MeSH terms: Hypoglycemia

Study Results

No Results Posted as of Jul 21, 2016