Does Insulin Requirement Post Cardiac Surgery Predicts The Risk Of Developing Diabetes

NCT04765982 | Unknown DMC

• 1 other identifier: MRC-01-20-806
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diabetes; cardiac surgery; non-diabetics

Outcome Measures

Primary Outcomes (4)

• Incidence of developing diabetes in patient with post operative stress hyperglycemia

  Testing patient on follow up for evidence of development of diabetes or pre-diabetes

  at 3 months

• Incidence of developing diabetes in patient with post operative stress hyperglycemia

  Testing patient on follow up for evidence of development of diabetes or pre-diabetes

  at 6 months

• Incidence of developing pre diabetes in patient with post operative stress hyperglycemia

  Testing patient on follow up for evidence of development of diabetes or pre-diabetes

  at 3 months

• Incidence of developing pre diabetes in patient with post operative stress hyperglycemia

  Testing patient on follow up for evidence of development of diabetes or pre-diabetes

  at 6 months

Secondary Outcomes (1)

• other morbidity measures

  1 year

Study Arms (2)

patients with less than 80% time in range

ACTIVE COMPARATOR

Better control group

Diagnostic Test: Checking diabetes development in follow up at 3 month

patients with more than 80% time in range

PLACEBO COMPARATOR

poor control group

Diagnostic Test: Checking diabetes development in follow up at 3 month

Interventions

Checking diabetes development in follow up at 3 month DIAGNOSTIC_TEST

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)

Also known as: Checking diabetes development in follow up at 6 month

patients with less than 80% time in range; patients with more than 80% time in range

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients above the age of 18 years subjected to cardiac surgery,

You may not qualify if:

• Diabetics.
• Patients who refuse to participate or who /can not sign informed consent.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad medical corporation

Doha, DA, 3050, Qatar

RECRUITING

Related Publications (6)

• Van den Berghe G. How does blood glucose control with insulin save lives in intensive care? J Clin Invest. 2004 Nov;114(9):1187-95. doi: 10.1172/JCI23506.

  PMID: 15520847 RESULT

• Guariguata L, Whiting DR, Hambleton I, Beagley J, Linnenkamp U, Shaw JE. Global estimates of diabetes prevalence for 2013 and projections for 2035. Diabetes Res Clin Pract. 2014 Feb;103(2):137-49. doi: 10.1016/j.diabres.2013.11.002. Epub 2013 Dec 1.

  PMID: 24630390 RESULT

• Saberi F, Heyland D, Lam M, Rapson D, Jeejeebhoy K. Prevalence, incidence, and clinical resolution of insulin resistance in critically ill patients: an observational study. JPEN J Parenter Enteral Nutr. 2008 May-Jun;32(3):227-35. doi: 10.1177/0148607108316195.

  PMID: 18443133 RESULT

• Marik PE. Critical illness-related corticosteroid insufficiency. Chest. 2009 Jan;135(1):181-193. doi: 10.1378/chest.08-1149.

  PMID: 19136406 RESULT

• Kovalaske MA, Gandhi GY. Glycemic control in the medical intensive care unit. J Diabetes Sci Technol. 2009 Nov 1;3(6):1330-41. doi: 10.1177/193229680900300613.

  PMID: 20144387 RESULT

• Omar AS, Salama A, Allam M, Elgohary Y, Mohammed S, Tuli AK, Singh R. Association of time in blood glucose range with outcomes following cardiac surgery. BMC Anesthesiol. 2015 Jan 26;15(1):14. doi: 10.1186/1471-2253-15-14. eCollection 2015.

  PMID: 25670921 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Dina F Alwaheidi

  Hamad medical coproation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina F Alwaheidi, MD

CONTACT

66346543; DAlwaheidi@hamad.qa

Amr IBRAHIM Omar, MD, PhD

CONTACT

66480831; a_s_omar@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: * The study will be a prospective cohort study * We will select patient without diabetes who will undergo cardiac surgery, patient will be divided into two groups group 1) Patients with uncontrolled blood sugar in the ICU; and group 2) patient with adequate control of blood sugar in ICU settings * The sample size will be calculated based on previous studies in critically ill patients

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: February 23, 2021
• Study Start: December 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 16, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)