Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery

NCT ID: NCT06468865

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2026-12-31

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.

Conditions

Hypoglycemia Non-Diabetic; Gastric Bypass Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continuous glucose monitor

The participants will wear a blinded (i.e. glucose levels are not displayed) Dexcom® G7 continuous glucose monitor for one week during the screening week.

After the screening 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.

Group Type: EXPERIMENTAL

Continuous glucose monitor (Dexcom® G7)

Intervention Type: DEVICE

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

No continuous glucose monitor

The participants will wear a blinded (i.e. glucose levels are not displayed) Dexcom® G7 continuous glucose monitor for one week during the screening week.

After the screening 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 not use a continuous glucose monitor during the following 5 weeks, but during week 6 the patient will wear a blinded continuous glucose monitor.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Continuous glucose monitor (Dexcom® G7)

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sykehuset i Vestfold HF

OTHER

Sponsor Role: lead

Responsible Party

Heidi Borgeraas

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Tønsberg, Vestfold, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Heidi Borgeraas, PhD

Role: CONTACT

heibor@siv.no

004746707000

Facility Contacts

Heidi Borgeraas, PhD

Role: primary

heibor@siv.no

+47 46707000

Dag Hofsø, MD, PhD

Role: backup

dag.hofso@siv.no

+47 90591666

Other Identifiers

596343

Identifier Type: -

Identifier Source: org_study_id