Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06468865

Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery

The goal of this clinical trial is to learn if continuous glucose monitoring works to treat postprandial hypoglycaemia in patients who have undergone gastric bypass surgery. The main question it aims to answer is:

• Is continuous glucose monitoring superior to usual care for prevention of postprandial hypoglycaemia in patients with verified postprandial hypoglycaemia after gastric bypass surgery?

Researchers will compare continuous glucose monitoring to usual care to see if continuous glucose monitoring works to treat postprandial hypoglycaemia.

Participants will:

* Use a continuous glucose monitor for 6 weeks or use no continuous glucose monitor for 5 weeks and wear a blinded continuous glucose monitor for 1 week. * Visit the clinic 2-3 times and have 2-3 phone consultations. * Register symptoms of hypoglycaemia, answer questionnaires, undergo a 24-hour dietary recall interview conducted by a registered dietitian, measure weight and body composition and take blood samples.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hypoglycemia Non-Diabetic Gastric Bypass Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

1Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust

Tønsberg, Vestfold, 3103, Norway

Location status: Recruiting

Location contact

Dag Hofsø, MD, PhD

CONTACT

[email protected]

+47 90591666

Dag Hofsø, MD, PhD

SUB_INVESTIGATOR

Heidi Borgeraas, PhD

CONTACT

[email protected]

+47 46707000

Heidi Borgeraas, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Gastric bypass surgery at least 1 year ago
  • Age ≥18 years
  • Symptomatic postprandial hypoglycaemia; capillary glucose level <3.0 mmol/L 1-4 hours after meals

Exclusion criteria

  • Not able to give informed consent
  • Reduced compliance due to severe mental and psychiatric conditions
  • Use of insulin or sulfonylureas
  • Use of systemic corticosteroids
  • Primary or secondary adrenal insufficiency
  • Insulinoma
  • Severe heart-, lung, liver- or kidney disease, cancer, malnutrition and other medical conditions causing fragility
  • Performed bariatric revisional surgery
  • Drug- or alcohol abuse
  • Pregnancy
  • Use of acarbose or octreotide in the treatment of postprandial hypoglycemia
  • Use of continuous glucose monitor

Treatment and study plan

Continuous glucose monitor (Dexcom® G7)

Device

Continuous glucose monitors measures glucose levels in the interstitial fluid every 5 minutes

Primary outcomes

  1. • Difference between the two treatment arms in change in weekly diurnal time spent with hypoglycaemia (interstitial glucose <3.0 mmol/L) from the screening week to week 6, measured with a continuous glucose monitor.

    Time frame: Screening (week 0) and week 6

    Interstitial glucose is measured for one week during the screening week and for one week during week 6.

Secondary outcomes

  1. • Difference between the two treatment arms in change in weekly diurnal time spent with hypoglycaemia (interstitial glucose <3.9 mmol/L) from the screening week to week 6, measured with a continuous glucose monitor.

    Time frame: Screening (week 0) and week 6

    Interstitial glucose is measured for one week during the screening week and one week during week 6.

  2. • Difference between the two treatment arms in change in weekly time (total and nocturnal) spent with hypoglycaemia (interstitial glucose <3.0 mmol/L and <3.9 mmol/L) from the screening week to week 6, measured with a continuous glucose monitor.

    Time frame: Screening (week 0) and week 6

    Interstitial glucose is measured for one week during the screening week and one week during week 6.

  3. • Difference between the two treatment arms in change in weekly events (diurnal, total and nocturnal) of hypoglycaemia (interstitial glucose <3.0 mmol/L and <3.9 mmol/L) from the sceening week to week 6, measured with a continuous glucose monitor.

    Time frame: Screening (week 0) and week 6

    Interstitial glucose is measured for one week during the screening week and one week during week 6.

Study contacts

Contact information is provided by the study sponsor or research team.

Heidi Borgeraas, PhD

CONTACT

[email protected]

004746707000

Sponsors and collaborators

Lead sponsor

Sykehuset i Vestfold HF

Other

Registry information

Official study title

Continuous Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery: The HypoSurge Randomized Clinical Trial

Acronym: HypoSurge

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2024
Registry last updated
Nov 5, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.