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

NCT ID: NCT05728320

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2026-03-01

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.

Conditions

Bariatric Surgery

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Gastric bypass

Subjects submitted to gastric bypass

Glucose monitoring with flash glucose monitor

Intervention Type: DEVICE

All groups will be monitorized with a flash glucose monitor and compared after 7-14 days.

Sleeve gastrectomy

Subjects submitted to sleeve gastrectomy

Glucose monitoring with flash glucose monitor

Intervention Type: DEVICE

All groups will be monitorized with a flash glucose monitor and compared after 7-14 days.

Normal control subjects

Subjects not submitted to bariatric surgery with IMC \< 25

Glucose monitoring with flash glucose monitor

Intervention Type: DEVICE

All groups will be monitorized with a flash glucose monitor and compared after 7-14 days.

Obese control subjects

Subjects not submitted to bariatric surgery with IMC \> 30

Glucose monitoring with flash glucose monitor

Intervention Type: DEVICE

All groups will be monitorized with a flash glucose monitor and compared after 7-14 days.

Interventions

Glucose monitoring with flash glucose monitor

All groups will be monitorized with a flash glucose monitor and compared after 7-14 days.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rio de Janeiro State University

OTHER

Sponsor Role: lead

Responsible Party

Luiz Guilherme Kraemer-Aguiar, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Laboratory for Clinical and Experimental Research on Vascular Biology

Rio de Janeiro, , Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Luiz Guilherme K de Aguiar, PhD

Role: primary

lgkraemeraguiar@gmail.com

+55(21)23340703

Karynne G Lisboa Lopes dos Santos, PhD

Role: backup

kjgolrj@gmail.com

(+5521) 23340703

Other Identifiers

Bariglivar

Identifier Type: -

Identifier Source: org_study_id