Clinical trial NCT06468865: Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery
Official title: Continuous Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery: The HypoSurge Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoglycemia Non-Diabetic
Gastric Bypass Surgery
Lead sponsor: Sykehuset i Vestfold HF
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: • 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.
timeFrame: Screening (week 0) and week 6
Secondary outcomes:
measure: • 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.
timeFrame: Screening (week 0) and week 6
measure: • 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.
timeFrame: Screening (week 0) and week 6
measure: • 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.
timeFrame: Screening (week 0) and week 6
Other outcomes:
Locations:
city: Tønsberg
country: Norway
facility: 1Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust
state: Vestfold
Study officials:
References: