NCT05728320

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)

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

3.5 years

First QC Date

January 3, 2023

Last Update Submit

April 14, 2024

Conditions

Bariatric Surgery

Keywords

HypoglycemiaCognitionGlycemic variabilityBariatric surgery

Outcome Measures

Primary Outcomes (2)

  • High glucose variability

    Interstitial blood glucose

    14 days

  • Unawareness hypoglycemia

    Interstitial blood glucose

    14 days

Study Arms (4)

Gastric bypass

Subjects submitted to gastric bypass

Device: Glucose monitoring with flash glucose monitor

Sleeve gastrectomy

Subjects submitted to sleeve gastrectomy

Device: Glucose monitoring with flash glucose monitor

Normal control subjects

Subjects not submitted to bariatric surgery with IMC \< 25

Device: Glucose monitoring with flash glucose monitor

Obese control subjects

Subjects not submitted to bariatric surgery with IMC \> 30

Device: Glucose monitoring with flash glucose monitor

Interventions

Glucose monitoring with flash glucose monitorDEVICE

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

Gastric bypassNormal control subjectsObese control subjectsSleeve gastrectomy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients submitted to GRYR and SG, for at least one year and control subjects not submitted to bariatric surgery

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory for Clinical and Experimental Research on Vascular Biology

Rio de Janeiro, 20550013, Brazil

RECRUITING

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2023

First Posted

February 15, 2023

Study Start

March 1, 2022

Primary Completion

September 1, 2025

Study Completion

March 1, 2026

Last Updated

April 16, 2024

Record last verified: 2024-04

Locations

BR(1)