Clinical trial NCT05728320: Glycemic Patterns After Bariatric Surgery and High Glycemic Variability and Hypoglycemia Unawareness Risk Factors
Official title: Analysis of Glycemic Patterns of Patients Undergoing Bariatric Surgery and Assessment of Risk Factors Capable of Predicting High Glycemic Variability and Unnoticed Hypoglycemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery
Keywords: Hypoglycemia
Cognition
Glycemic variability
Bariatric surgery
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients submitted to GRYR and SG, for at least one year and control subjects not submitted to bariatric surgery

Brief summary: 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)

Detailed 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.

Eligibility 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

Primary outcomes:
measure: High glucose variability
timeFrame: 14 days
measure: Unawareness hypoglycemia
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Laboratory for Clinical and Experimental Research on Vascular Biology
Study officials:
References: