Examining glycemic patterns after bariatric surgery
Analysis of Glycemic Patterns of Patients Undergoing Bariatric Surgery and Assessment of Risk Factors Capable of Predicting High Glycemic Variability and Unnoticed Hypoglycemia
This study looks at the blood sugar patterns of people aged 18-60 who have had bariatric surgery to see if they experience unnoticed low blood sugar and to identify any risk factors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Rio de Janeiro State University Academic / other |
| Locations | 1 site (Rio De Janeiro) |
| Trial ID | NCT05728320 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the glycemic patterns of patients who have undergone bariatric surgery, specifically reduction gastroplasty with Roux-en-Y reconstruction and sleeve gastrectomy. It aims to identify risk factors that predict episodes of unnoticed hypoglycemia and high glycemic variability. Eligible participants, aged 18-60 years, will wear a flash glucose monitor for 7 to 14 days to collect data on their glucose levels. The study is conducted at the Multiuser Clinical Research Center in Rio de Janeiro, focusing on patients who have been under medical follow-up for at least one year post-surgery.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-60 who have undergone reduction gastroplasty or sleeve gastrectomy at least one year prior and are under medical follow-up.
Not a fit: Patients using certain hypoglycemic or hyperglycemic medications, those on very restrictive diets, or with severe health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk for hypoglycemia, leading to better management and improved outcomes after bariatric surgery.
How similar studies have performed: While there have been studies on glycemic variability post-bariatric surgery, this specific focus on unnoticed hypoglycemia and risk factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients submitted to GRYR and SG, for at least one year, undergoing medical follow-up at the Multiuser Clinical Research Center (CePeM) of the Pedro Ernesto University Hospital (HUPE). Exclusion Criteria: * patients using hypoglycemic drugs (biguanides, sulfonylureas, glinides, acarbose, GLP-1 analogues, SGLT-2 inhibitors, DPP-IV inhibitors and insulin) and hyperglycemic drugs (corticosteroids, high-dose thiazide diuretics, beta-blockers, diazoxide and octreotide) , very restrictive diets (intermittent fasting or ketogenic diet), pregnant women, kidney, heart and/or liver failure, history of neurological disorder, visual or hearing impairment, being treated for alcohol or drug abuse, severe psychiatric disorders (schizophrenia, bipolar disorder ), vitamin B12 deficiency, iron deficiency anemia, patients with neurodegenerative diseases of the brain or retina or cerebrovascular diseases and those who do not agree to sign the informed consent form
Where this trial is running
Rio De Janeiro
- Laboratory for Clinical and Experimental Research on Vascular Biology — Rio De Janeiro, Brazil (Recruiting)
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.