Bariatric SurgeryNCT05728320
Glycemic Patterns After Bariatric Surgery and High Glycemic Variability and Hypoglycemia Unawareness Risk Factors
An observational study of Bariatric Surgery, run by Rio de Janeiro State University at 1 site in Brazil.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Glucose monitoring with flash glucose monitor
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2022to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients submitted to GRYR and SG, for at least one year and control subjects not submitted to bariatric surgery
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Laboratory for Clinical and Experimental Research on Vascular Biology
Rio de Janeiro, 20550013
Luiz Guilherme K de Aguiar, PhD, +55(21)23340703, lgkraemeraguiar@gmail.com
Karynne G Lisboa Lopes dos Santos, PhD, (+5521) 23340703, kjgolrj@gmail.com
About this study
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
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)
Read the 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
- Being tested
- Glucose monitoring with flash glucose monitor
- Keywords
- Hypoglycemia, Cognition, Glycemic variability, Bariatric surgery
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose monitoring with flash glucose monitorDevice
All groups will be monitorized with a flash glucose monitor and compared after 7-14 days.
| Study group | Role | What they receive |
|---|---|---|
| Gastric bypass | Subjects submitted to gastric bypass Receives: Device: Glucose monitoring with flash glucose monitor | |
| Sleeve gastrectomy | Subjects submitted to sleeve gastrectomy Receives: Device: Glucose monitoring with flash glucose monitor | |
| Normal control subjects | Subjects not submitted to bariatric surgery with IMC < 25 Receives: Device: Glucose monitoring with flash glucose monitor | |
| Obese control subjects | Subjects not submitted to bariatric surgery with IMC > 30 Receives: Device: Glucose monitoring with flash glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
High glucose variability
Interstitial blood glucose
Measured: 14 days
Unawareness hypoglycemia
Interstitial blood glucose
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Mar 2022
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Guilherme Kraemer-Aguiar, MD, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728320
- Sponsor's protocol ID
- Bariglivar
- Status last verified
- Apr 2024
- First submitted
- 3 Jan 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05728320
- Acronym / sponsor ID
- Bariglivar
- Conditions
- Bariatric Surgery
- Keywords
- Hypoglycemia, Cognition, Glycemic variability, Bariatric surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Gastric bypass | – | Device: Glucose monitoring with flash glucose monitorSubjects submitted to gastric bypass |
| Sleeve gastrectomy | – | Device: Glucose monitoring with flash glucose monitorSubjects submitted to sleeve gastrectomy |
| Normal control subjects | – | Device: Glucose monitoring with flash glucose monitorSubjects not submitted to bariatric surgery with IMC < 25 |
| Obese control subjects | – | Device: Glucose monitoring with flash glucose monitorSubjects not submitted to bariatric surgery with IMC > 30 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients submitted to GRYR and SG, for at least one year and control subjects not submitted to bariatric surgery
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose monitoring with flash glucose monitorAll groups will be monitorized with a flash glucose monitor and compared after 7-14 days. | Device | Gastric bypass, Normal control subjects, Obese control subjects, Sleeve gastrectomy |
Primary outcome
High glucose variability
Time frame: 14 days
Interstitial blood glucose
Unawareness hypoglycemia
Time frame: 14 days
Interstitial blood glucose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laboratory for Clinical and Experimental Research on Vascular Biology
Rio de Janeiro, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery, run by Rio de Janeiro State University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High glucose variability (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024; AzTrials last refreshed its copy on 1 Nov 2026.