Variable Effects of Anti-diabetics on Stress Hyperglycemia Ratio

NCT ID: NCT05822674

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-02-01

Brief Summary

A blood glucose level of equal to or greater than 180 mg/dL that occurred during stress in a patient without diabetes mellitus (DM) is termed stress hyperglycemia (SH). The stress hyperglycemia ratio (SHR) is defined as the fasting blood glucose divided by the blood glucose level that is calculated from the glycosylated hemoglobin (HBA1c) value on admission. A significantly higher SHR is associated with worse prognostic biomarkers in diabetic patients with complications

Detailed Description

Stress hyperglycemia (SH) is an increase in circulating glucose levels in biological fluids as a physiological response to stress in diabetic patients who are known or newly diagnosed, or a pathological condition associated with in-hospital-related hyperglycemia.

Interventions. Through their pleiotropic effects, some oral hypoglycemic agents improved stress hyperglycemia. When compared to non-SGLT-I (sodium glucose transporter-inhibitor) users, diabetic patients who used (SGLT-I) and had an acute myocardial infarction had less prevalent stress hyperglycemia, a smaller infarct size, and evidence of a low inflammatory response. The rationale this study is to evaluate the SHR in T2D patients who do not have serious illnesses and are managed with oral hypoglycemic agents

Conditions

Type 2 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Sitagliptin/metformin

Patients with T2D treated with sitagliptin/metformin (50/500mg) once daily for 10 weeks

Sitagliptin/metformin ( 50/500mg) Oral Tablet

Intervention Type: DRUG

The drug was prescribed once daily per oral for 10 weeks

Empagliflozin/metformin

Patients with T2D treated with empagliflozin/metformin (10/500mg) once daily for 10 weeks

Empagliflozin/metformin(10/500mg) Oral Tablet

Intervention Type: DRUG

The drug was prescribed once daily per oral for 10 weeks

Interventions

Sitagliptin/metformin ( 50/500mg) Oral Tablet

The drug was prescribed once daily per oral for 10 weeks

Intervention Type: DRUG

Empagliflozin/metformin(10/500mg) Oral Tablet

The drug was prescribed once daily per oral for 10 weeks

Intervention Type: DRUG

Other Intervention Names

Group I; Group II

Eligibility Criteria

Inclusion Criteria

• Age ≥35 years
• Diagnosis of Type 2 diabetes
• Absence of serious illnesses
• No evidence of trauma

Exclusion Criteria

• Overt complications of diabetes
• Any participant used antibiotics for infectious diseases
• Any participant used non-steroidal antiinflammatory drugs
• Current or past history of mental diseases
• Current hematological diseases
• Pregnancy
• Nursing mothers

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Diyala

OTHER

Sponsor Role: lead

Responsible Party

Marwan Salih Mohamad Al-Nimer

Emeritus Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ismail Latif

Role: STUDY_DIRECTOR

The Dean College of Medicine, University of Diyal

Locations

College of Medicine, University of Diyala

Baqubah, Diyālá, Iraq

Countries

Iraq

Other Identifiers

University of Diyala

Identifier Type: -

Identifier Source: org_study_id