NCT02665715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

10 months

First QC Date

January 25, 2016

Last Update Submit

July 20, 2016

Conditions

Bariatric Surgery (Gastric Bypass)

Keywords

Reactive hypoglycemiaHyperinsulinaemiaDietGlucagon-like Peptide-1GlucagonPeptide YYGhrelin

Outcome Measures

Primary Outcomes (1)

  • Nadir plasma glucose

    Between low carbohydrate meal and standard meal.

    0-240 min, 240-480 min

Secondary Outcomes (9)

  • Peak plasma glucose

    0-240 min, 240-480 min

  • Time to nadir glucose

    0-240 min, 240-480 min

  • Time to peak glucose

    0-240 min, 240-480 min

  • Postprandial incremental glucose area

    0-240 min, 240-480 min

  • Postprandial decremental glucose area

    0-240 min, 240-480 min

  • +4 more secondary outcomes

Study Arms (2)

Low carbohydrate/Standard carbohydrate

EXPERIMENTAL

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 mealsOther: Standard carbohydrate meals

Standard carbohydrate/Low carbohydrate

EXPERIMENTAL

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 mealsOther: Standard carbohydrate meals

Interventions

Low carbohydrate mealsOTHER

Meal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40%

Low carbohydrate/Standard carbohydrateStandard carbohydrate/Low carbohydrate
Standard carbohydrate mealsOTHER

Meal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30%

Low carbohydrate/Standard carbohydrateStandard carbohydrate/Low carbohydrate

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Fasting plasma glucose concentration \> 7mmol/L
  • Critical illness
  • Hgb \< 6.5 mM
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrinology Research Center, Hvidovre University Hospital

Hvidovre, Copenhagen, 2650, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 30624666DERIVED

MeSH Terms

Conditions

HypoglycemiaHyperinsulinism

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Kirstine Bojsen-Moller, MD, Postdoc

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

  • Sten Madsbad, MD, Prof

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD-Student

Study Record Dates

First Submitted

January 25, 2016

First Posted

January 28, 2016

Study Start

August 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 21, 2016

Record last verified: 2016-07

Locations

DK(1)