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

Analysis of Glycemic Patterns of Patients Undergoing Bariatric Surgery and Assessment of Risk Factors Capable of Predicting High Glycemic Variability and Unnoticed Hypoglycemia

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)

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery
• Intervention / Treatment: Device: Glucose monitoring with flash glucose monitor

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Brazil
  • Rio De Janeiro, Brazil, 20550013
    • Recruiting
    • Laboratory for Clinical and Experimental Research on Vascular Biology
    • Principal Investigator: Luiz Guilherme K de Aguiar, PhD
    • Sub-Investigator: Karynne G Lisboa Lopes dos Santos, PhD
    • Contact: Luiz Guilherme K de Aguiar, PhD; Phone Number: +55(21)23340703; Email: lgkraemeraguiar@gmail.com
    • Contact: Karynne G Lisboa Lopes dos Santos, PhD; Phone Number: (+5521) 23340703; Email: kjgolrj@gmail.com
    • Sub-Investigator: Daniel S da Silva, Graduate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gastric bypass; Subjects submitted to gastric bypass	Device: Glucose monitoring with flash glucose monitor; All groups will be monitorized with a flash glucose monitor and compared after 7-14 days.
Sleeve gastrectomy; Subjects submitted to sleeve gastrectomy	Device: Glucose monitoring with flash glucose monitor; 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	Device: Glucose monitoring with flash glucose monitor; 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	Device: Glucose monitoring with flash glucose monitor; All groups will be monitorized with a flash glucose monitor and compared after 7-14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High glucose variability	Interstitial blood glucose	14 days
Unawareness hypoglycemia	Interstitial blood glucose	14 days

Collaborators and Investigators

• Sponsor: Rio de Janeiro State University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: February 11, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Hypoglycemia; Bariatric surgery; Cognition; Glycemic variability
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: Bariglivar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No