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Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery

NCT06468865 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-11-05

No results posted yet for this study

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.

Conditions

  • Hypoglycemia Non-Diabetic
  • Gastric Bypass Surgery

Interventions

DEVICE

Continuous glucose monitor (Dexcom® G7)

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

Sponsors & Collaborators

  • Sykehuset i Vestfold HF

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-12
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06468865 on ClinicalTrials.gov