Do cortisol changes after gastric bypass or sleeve cause reactive low blood sugar?
Cortisol and Obesity - A Vicious Cycle? Hypoglycemia After Bariatric Surgery - Association With Cortisol Metabolism?
Esbjerg Hospital - University Hospital of Southern Denmark · NCT06896682
This project will see if cortisol changes after gastric bypass or sleeve surgery are linked to reactive low blood sugar in adults who had surgery at least 12 months ago.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Esbjerg Hospital - University Hospital of Southern Denmark (other) |
| Locations | 1 site (Esbjerg) |
| Trial ID | NCT06896682 on ClinicalTrials.gov |
What this trial studies
This observational project will enroll about 100 people who underwent Roux-en-Y gastric bypass or sleeve at least one year earlier. Participants attend two visits at Esbjerg Hospital with blood draws and an ACTH adrenal stimulation test, wear a continuous glucose monitor for around ten days, and provide 24-hour urine collections and saliva samples if hypoglycemia symptoms occur. The study compares cortisol production and metabolism measures with continuous glucose patterns and reported symptoms to determine whether altered cortisol handling contributes to postbariatric reactive hypoglycemia. No treatments are administered; the protocol is focused on diagnostic testing and monitoring.
Who should consider this trial
Good fit: Adults who had Roux-en-Y gastric bypass or sleeve at least 12 months ago, who are not pregnant or breastfeeding and who are not taking excluded medications or have excluded medical conditions, are ideal candidates.
Not a fit: People who are pregnant or breastfeeding, have known adrenal disease, nephrotic syndrome, liver cirrhosis, severe malnutrition, are on corticosteroids, opioid-containing medications, estrogen therapy, or already have medically treated postbariatric hypoglycemia are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the results could identify hormonal causes of postbariatric reactive hypoglycemia and suggest new ways to prevent or treat it.
How similar studies have performed: Some prior studies have measured cortisol changes after bariatric surgery, but few have directly linked cortisol metabolism to postbariatric reactive hypoglycemia, so this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants must have undergone one of the following bariatric procedures at least 12 months prior: * Roux-en-Y gastric bypass * Gastric sleeve Exclusion Criteria * Pregnancy and breastfeeding * Nephrotic syndrome (kidney disease with protein loss in urine), liver cirrhosis, or severe malnutrition, as these conditions reduce cortisol-binding globulin (CBG) levels, affecting total cortisol concentration * Use of corticosteroid medications, such as prednisolone * Use of opiod-containing medication * Use of medications containing estrogen, such as hormone therapy for menopause * Known adrenal disease affecting cortisol metabolism, including autonomous cortisol production and Cushing's syndrome * Diabetes that does not require medical treatment * Previously diagnosed reactive hypoglycemia after bariatric surgery requiring medical treatment
Where this trial is running
Esbjerg
- Esbjerg Hospital — Esbjerg, Denmark (RECRUITING)
Study contacts
- Study coordinator: Charlotte R Stolberg, MD PhD
- Email: charlotte.ron.stolberg@rsyd.dk
- Phone: +4579183127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postbariatric Hypoglycemia, cortisol, bariatric surgery, postbariatric hypoglycemia