Clinical trial NCT02665715: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery (Gastric Bypass)
Keywords: Reactive hypoglycemia
Hyperinsulinaemia
Diet
Glucagon-like Peptide-1
Glucagon
Peptide YY
Ghrelin
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2016-01-28
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Nadir plasma glucose
timeFrame: 0-240 min, 240-480 min
Secondary outcomes:
measure: Peak plasma glucose
timeFrame: 0-240 min, 240-480 min
measure: Time to nadir glucose
timeFrame: 0-240 min, 240-480 min
measure: Time to peak glucose
timeFrame: 0-240 min, 240-480 min
measure: Postprandial incremental glucose area
timeFrame: 0-240 min, 240-480 min
measure: Postprandial decremental glucose area
timeFrame: 0-240 min, 240-480 min
measure: Postprandial incremental insulin area
timeFrame: 0-240 min, 240-480 min
measure: Postprandial incremental GLP-1 area
timeFrame: 0-240 min, 240-480 min
measure: Time below basline glucose concentrations
timeFrame: 0-480 min
measure: Glycemic excursions
timeFrame: 0-480 min
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Endocrinology Research Center, Hvidovre University Hospital
state: Copenhagen
Study officials:
affiliation: Hvidovre University Hospital
name: Kirstine Bojsen-Moller, MD, Postdoc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre University Hospital
name: Sten Madsbad, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.