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

A

Amirsalar Samkani

Status

Completed

Conditions

Bariatric Surgery (Gastric Bypass)

Treatments

Other: Low carbohydrate meals
Other: Standard carbohydrate meals

Study type

Interventional

Funder types

Other

Identifiers

NCT02665715
DK-REAKTIV-15

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

25 to 70 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Low carbohydrate/Standard carbohydrate
Experimental group
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.
Treatment:
Other: Standard carbohydrate meals
Other: Low carbohydrate meals
Standard carbohydrate/Low carbohydrate
Experimental group
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.
Treatment:
Other: Standard carbohydrate meals
Other: Low carbohydrate meals

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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