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

No results posted yet for this study

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

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

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04765982 on ClinicalTrials.gov