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

Primary Purpose

Bariatric Surgery (Gastric Bypass)

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Low carbohydrate meals
Standard carbohydrate meals
Sponsored by
Amirsalar Samkani
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bariatric Surgery (Gastric Bypass) focused on measuring Reactive hypoglycemia, Hyperinsulinaemia, Diet, Glucagon-like Peptide-1, Glucagon, Peptide YY, Ghrelin

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Endocrinology Research Center, Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low carbohydrate/Standard carbohydrate

Standard carbohydrate/Low carbohydrate

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Nadir plasma glucose
Between low carbohydrate meal and standard meal.

Secondary Outcome Measures

Peak plasma glucose
Between low carbohydrate meal and standard meal.
Time to nadir glucose
Between low carbohydrate meal and standard meal.
Time to peak glucose
Between low carbohydrate meal and standard meal.
Postprandial incremental glucose area
Between low carbohydrate meal and standard meal.
Postprandial decremental glucose area
Between low carbohydrate meal and standard meal.
Postprandial incremental insulin area
Between low carbohydrate meal and standard meal.
Postprandial incremental GLP-1 area
Between low carbohydrate meal and standard meal.
Time below basline glucose concentrations
Between low carbohydrate meal and standard meal.
Glycemic excursions
Between low carbohydrate meal and standard meal.

Full Information

First Posted
January 25, 2016
Last Updated
July 20, 2016
Sponsor
Amirsalar Samkani
Collaborators
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02665715
Brief Title
Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet?
Official Title
Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amirsalar Samkani
Collaborators
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery (Gastric Bypass)
Keywords
Reactive hypoglycemia, Hyperinsulinaemia, Diet, Glucagon-like Peptide-1, Glucagon, Peptide YY, Ghrelin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low carbohydrate/Standard carbohydrate
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard carbohydrate/Low carbohydrate
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Low carbohydrate meals
Intervention Description
Meal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40%
Intervention Type
Other
Intervention Name(s)
Standard carbohydrate meals
Intervention Description
Meal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30%
Primary Outcome Measure Information:
Title
Nadir plasma glucose
Description
Between low carbohydrate meal and standard meal.
Time Frame
0-240 min, 240-480 min
Secondary Outcome Measure Information:
Title
Peak plasma glucose
Description
Between low carbohydrate meal and standard meal.
Time Frame
0-240 min, 240-480 min
Title
Time to nadir glucose
Description
Between low carbohydrate meal and standard meal.
Time Frame
0-240 min, 240-480 min
Title
Time to peak glucose
Description
Between low carbohydrate meal and standard meal.
Time Frame
0-240 min, 240-480 min
Title
Postprandial incremental glucose area
Description
Between low carbohydrate meal and standard meal.
Time Frame
0-240 min, 240-480 min
Title
Postprandial decremental glucose area
Description
Between low carbohydrate meal and standard meal.
Time Frame
0-240 min, 240-480 min
Title
Postprandial incremental insulin area
Description
Between low carbohydrate meal and standard meal.
Time Frame
0-240 min, 240-480 min
Title
Postprandial incremental GLP-1 area
Description
Between low carbohydrate meal and standard meal.
Time Frame
0-240 min, 240-480 min
Title
Time below basline glucose concentrations
Description
Between low carbohydrate meal and standard meal.
Time Frame
0-480 min
Title
Glycemic excursions
Description
Between low carbohydrate meal and standard meal.
Time Frame
0-480 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirstine Bojsen-Moller, MD, Postdoc
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sten Madsbad, MD, Prof
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endocrinology Research Center, Hvidovre University Hospital
City
Hvidovre
State/Province
Copenhagen
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
30624666
Citation
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.
Results Reference
derived

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

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