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Completed

NCT Number: NCT02665715

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

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.

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endocrinology Research Center, Hvidovre University Hospital

Hvidovre, Copenhagen, 2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low carbohydrate meals

Other

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

Standard carbohydrate meals

Other

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

Primary outcomes

  1. Nadir plasma glucose

    Time frame: 0-240 min, 240-480 min

    Between low carbohydrate meal and standard meal.

Secondary outcomes

  1. Peak plasma glucose

    Time frame: 0-240 min, 240-480 min

    Between low carbohydrate meal and standard meal.

  2. Time to nadir glucose

    Time frame: 0-240 min, 240-480 min

    Between low carbohydrate meal and standard meal.

  3. Time to peak glucose

    Time frame: 0-240 min, 240-480 min

    Between low carbohydrate meal and standard meal.

  4. Postprandial incremental glucose area

    Time frame: 0-240 min, 240-480 min

    Between low carbohydrate meal and standard meal.

  5. Postprandial decremental glucose area

    Time frame: 0-240 min, 240-480 min

    Between low carbohydrate meal and standard meal.

  6. Postprandial incremental insulin area

    Time frame: 0-240 min, 240-480 min

    Between low carbohydrate meal and standard meal.

  7. Postprandial incremental GLP-1 area

    Time frame: 0-240 min, 240-480 min

    Between low carbohydrate meal and standard meal.

  8. Time below basline glucose concentrations

    Time frame: 0-480 min

    Between low carbohydrate meal and standard meal.

  9. Glycemic excursions

    Time frame: 0-480 min

    Between low carbohydrate meal and standard meal.

Sponsors and collaborators

Lead sponsor

Amirsalar Samkani

Other

Collaborators

  • Hvidovre University Hospital

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 28, 2016
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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