Gastric Bypass Surgery, Hypoglycemia Non-Diabetic
Conditions
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.
Interventions
DEVICEContinuous glucose monitor (Dexcom® G7)
Continuous glucose monitors measures glucose levels in the interstitial fluid every 5 minutes
Sponsors
Sykehuset i Vestfold HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • 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
| Measure | Time frame | Description |
|---|---|---|
| • 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. |
Countries
Norway
Contacts
Primary ContactHeidi Borgeraas, PhD
Outcome results
None listed