Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery

Not Applicable

Recruiting

• Conditions: Hypoglycemia Non-Diabetic; Gastric Bypass Surgery
• Interventions: Device: Continuous glucose monitor (Dexcom® G7)

• Registration Number: NCT06468865
• Lead Sponsor: Sykehuset i Vestfold HF

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-20
• Study First Posted: 2024-06-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05
• Study Start: 2024-11-12
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous glucose monitor	Continuous glucose monitor (Dexcom® G7)	The participants will wear a blinded (i.e. glucose levels are not displayed) Dexcom® G7 continuous glucose monitor for 7 days during the baseline week. After the baseline-week, the patients will be given dietary guidance on how to avoid hypoglycaemia and be given a capillary glucometer (standard treatment procedure). The patients will also use a continuous glucose monitor and receiver which displays real-time glucose levels, for 6 weeks, to learn how to avoid hypoglycaemia.

Primary Outcome Measures

Name	Time	Method
• 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.	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 Outcome Measures

Name	Time	Method
• 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.	Screening (week 0) and week 6	Interstitial glucose is measured for one week during the screening week and one week during week 6.
• 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.	Screening (week 0) and week 6	Interstitial glucose is measured for one week during the screening week and one week during week 6.
• 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.	Screening (week 0) and week 6	Interstitial glucose is measured for one week during the screening week and one week during week 6.

Trial Locations

Locations (1)

1Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust; 🇳🇴 Tønsberg, Vestfold, Norway