Does Insulin Requirement Post Cardiac Surgery Predicts The Risk Of Developing Diabetes
NCT04765982 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2023-02-16
Summary
The patient outcome in cardiac surgery is substantially linked to the occurrence of hyperglycemia. Qatar ranks 5th in the rate of diabetes globally; Moreover diabetics comprise more than 40% of patients admitted to the cardiac surgery intensive care unit (CTICU) in Qatar heart hospital. This prevalence is higher than the rest of the world. These numbers are projected to increase with accompanied morbidity-mortality hazardous by 2030 if the adequate intervention will not be directed towards better control of blood sugar within ICU and the hospital stay. The overall objective of this project is to explore the immunological profile in patients with poor glycemic control within their intensive care unit stay in Qatar. 'time in range' (TIR) was used for defining glycemic control within the ICU, where patients with time in range more than 80%, (in presence or absence of debates), had better outcomes than those with time in range less than 80% TIR. Notably, regarding wound infection, lengths of ventilation and ICU stay; they were not candidates to recurrent hypoglycemic episodes also. The high HbA1C preoperatively is probably a valid forecaster of indigent glycemic control. Previous studies demonstrated conversion of non-diabetics to diabetics when they face stress of critical illness. No previous studies explored this possible conversion cardiac surgery. Our primary objectives will be to determine whether non-diabetic patients with poor glycemic control in cardiac surgery would develop subsequent diabetes later on. Investigators will follow up non-diabetics patients after 3 months to satisfy this aim. Investigators will include all patients who will undergo cardiac surgery over two years from the time of approval without evidence of diabetes as documented by glycated hemoglobin (HbA1C). Patients will be followed up to one year with laboratory investigations to document whether they will develop diabetes or not. Data will be stored and statistically analyzed. Investigators expect to have details about the possible conversion in this high-risk population.
Conditions
- Diabetes
- Pre-diabetes
Interventions
- DIAGNOSTIC_TEST
-
Checking diabetes development in follow up at 3 month
An outpatient visit will be planned approximately three months after ICU discharge. At the time of this visit, we will obtain age, BMI, waist circumference, diet, exercise, history of hypertension and family and personal history of elevated blood glucose to calculate the Finnish diabetes risk score (FINDRISC) questionnaire. (28) Oral glucose tolerance test (OGTT) will be performed according to the guidelines of the World Health Organization (WHO) with 75-g glucose load. Diabetes will be diagnosed according to the American Diabetes Association guidelines that stat fasting plasma glucose ≥126 mg/dl(7mmol/L) and/or 2-h plasma glucose during the OGTT ≥200 mg/dl (11.1mmol/L) and/or HbA1c ≥6.5 % (48 mmol/L); impaired glucose tolerance is noted when 2-h plasma glucose during the OGTT is between 140-200 mg/dl (7.7-11.1mmol/L). Impaired fasting glucose defined as fasting plasma glucose between 100-126 mg/dl (55.7mmol/L). (29)
Sponsors & Collaborators
-
Hamad Medical Corporation
lead INDUSTRY
Principal Investigators
-
Dina F Alwaheidi · Hamad medical coproation
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-01
- Primary Completion
- 2023-03-31
- Completion
- 2023-12-31
Countries
- Qatar
Study Locations
More Related Trials
-
Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia?
NCT00468494 ·Status: COMPLETED
-
Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery
NCT01361594 ·Status: COMPLETED ·Phase: PHASE3
-
Glycemic Control to Prevent Cardiac Morbidity in Vascular Surgery
NCT00328094 ·Status: TERMINATED ·Phase: NA
-
Improving Neurologic Outcomes in People With Diabetes Who Are Undergoing Heart Surgery
NCT00836329 ·Status: COMPLETED ·Phase: PHASE3
-
Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery
NCT00524472 ·Status: COMPLETED ·Phase: NA
-
Can Enhanced Glycemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting?
NCT00899483 ·Status: UNKNOWN ·Phase: NA
-
Improving Outcomes In Diabetic Patients During CABG Surgery By Optimizing Glycemic Control
NCT00460499 ·Status: COMPLETED ·Phase: PHASE1
-
Carbohydrate Loading on Insulin Resistance in Open Heart Surgery
NCT06901947 ·Status: COMPLETED ·Phase: NA
-
Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients
NCT04862234 ·Status: TERMINATED ·Phase: PHASE4
-
Etiology, Assessment and Treatment of Post-gastric Bypass Severe Hypoglycemia
NCT01865760 ·Status: COMPLETED ·Phase: NA
-
Intraoperative Insulin Administration at Cardiac Surgery for Diabetic Patients
NCT04824586 ·Status: COMPLETED ·Phase: PHASE4
-
Perioperative Glucose and Insulin Changes in Major Urologic Surgeries
NCT05222659 ·Status: COMPLETED
-
Comparing Blood Glucose Control Intraoperative Between Insulin Drip vs. Insulin Boluses Will Provide Valuable Information on the Optimal Method for Achieving Blood Glucose Control Intraoperatively.
NCT07056088 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Glycemic Stability During the Intraoperative Period Among Patients With DM Undergoing CABG Surgery
NCT04451655 ·Status: COMPLETED ·Phase: NA
-
Glycemic Variability and Autonomic Nervous System in Cardiac Surgery Patients
NCT05454735 ·Status: COMPLETED
-
Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
NCT03770637 ·Status: COMPLETED ·Phase: PHASE2
-
Intravenous Bolus-infusion Versus Sliding Scale of Insulin for Intra-operative Glycemic Control
NCT05136157 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
The Association Between Peri-Operative Hyperglycemia and Major Morbidity and Mortality
NCT00487162 ·Status: TERMINATED ·Phase: NA
-
SHOrt-term Glycemic Control for Reducing Post-SURGical Complications
NCT06334068 ·Status: COMPLETED ·Phase: NA
-
Impact of Blood Glucose Levels on in ICU Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
NCT06453967 ·Status: NOT_YET_RECRUITING
-
Stress Induced Hyperglycemia In Trauma
NCT02999386 ·Status: COMPLETED
-
Efficacy and Safety of a Glargine-based Hospital Discharge Algorithm in Coronary Artery Bypass Graft (CABG) Patients
NCT01792830 ·Status: COMPLETED ·Phase: PHASE3
-
Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery
NCT00992901 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Perioperative Continuation of Metformin Therapy in Patients With Typ 2 Diabetes Mellitus Undergoing Non-cardiac Surgery
NCT04284722 ·Status: UNKNOWN ·Phase: PHASE4
-
Adverse Effects of Systemic Hypoglycemia Exposure on Endothelial Function in Humans
NCT01660009 ·Status: TERMINATED ·Phase: NA