Actively Recruiting
Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery
Led by Sykehuset i Vestfold HF · Updated on 2024-11-05
100
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gastric bypass surgery at least 1 year ago
- Age 18 years or older
- Symptoms of postprandial hypoglycemia with capillary glucose below 3.0 mmol/L within 1 to 4 hours after meals
You will not qualify if you...
- Unable to give informed consent
- Severe mental or psychiatric conditions reducing compliance
- Use of insulin or sulfonylureas
- Use of systemic corticosteroids
- Primary or secondary adrenal insufficiency
- Insulinoma
- Severe heart, lung, liver, or kidney disease, cancer, malnutrition, or other conditions causing fragility
- Previous bariatric revisional surgery
- Drug or alcohol abuse
- Pregnancy
- Use of acarbose or octreotide for postprandial hypoglycemia
- Current use of a continuous glucose monitor
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
1Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust
Tønsberg, Vestfold, Norway, 3103
Actively Recruiting
Research Team
H
Heidi Borgeraas, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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