Glycemic Patterns After Bariatric Surgery and High Glycemic Variability and Hypoglycemia Unawareness Risk Factors

Rio de Janeiro State University

Status

Enrolling

Conditions

Bariatric Surgery

Treatments

Device: Glucose monitoring with flash glucose monitor

Study type

Observational

Funder types

Other

Identifiers

NCT05728320

Bariglivar

Details and patient eligibility

About

Full description

To study the glycemic patterns of patients undergoing bariatric surgery and what are the risk factors capable of predicting episodes of unnoticed hypoglycemia and high glycemic variability, evaluating patients who underwent reduction gastroplasty with Roux-en-Y reconstruction (GRYR) and sleeve gastrectomy (SG). Methods: Patients of both sexes, aged 18-60 years, submitted to GRYR and SG, for at least one year, under medical follow-up at the Multiuser Clinical Research Center (CePeM). 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. Eligible patients will undergo a medical consultation, which will consist of anamnesis and physical examination and will wear a flash glucose monitor, model Freestyle Libre by Abbott, which should be used for a period of 7 to 14 days. They will complete the Three Factor Eating Questionnaire R21 (TFEQ-R21), International Physical Activity Questionnaire (IPAQ), Gold Questionnaire, Edinburgh Hypoglycemia Symptom Scale (EHSS), Rey Auditory Verbal Learning Test (RAVLT), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Trail Making Test (TMT) and Stroop Test. Will be evaluated as possible predictive factors the time elapsed from surgery, surgical technique, excess weight loss, rate of weight regain, previous diabetes mellitus, age, sex, resting heart rate, history of cholecystectomy, laboratory values of glycated hemoglobin, fasting glycemia, lipidogram and renal, thyroid and hepatic functions.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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