Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05728320
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2023-01-03
Brief Title:
Glycemic Patterns After Bariatric Surgery and High Glycemic Variability and Hypoglycemia Unawareness Risk Factors
Sponsor:
Rio de Janeiro State University
Organization:
Rio de Janeiro State University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None