RecruitingNot ApplicableNCT06468865

Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery

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


Sponsor

Sykehuset i Vestfold HF

Enrollment

100 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria12

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEContinuous glucose monitor (Dexcom® G7)

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


Locations(1)

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

Tønsberg, Vestfold, Norway

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06468865


Related Trials