Variable Effects of Anti-diabetics on Stress Hyperglycemia Ratio

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Sitagliptin/metformin ( 50/500mg) Oral Tablet; Drug: Empagliflozin/metformin(10/500mg) Oral Tablet

• Registration Number: NCT05822674
• Lead Sponsor: University of Diyala

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

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-02-01
• Study First Submitted: 2023-03-08
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-07
• Last Update Submitted: 2023-04-07
• Study First Posted: 2023-04-21
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sitagliptin/metformin	Sitagliptin/metformin ( 50/500mg) Oral Tablet	Patients with T2D treated with sitagliptin/metformin (50/500mg) once daily for 10 weeks
Empagliflozin/metformin	Empagliflozin/metformin(10/500mg) Oral Tablet	Patients with T2D treated with empagliflozin/metformin (10/500mg) once daily for 10 weeks

Primary Outcome Measures

Name	Time	Method
Stress hyperglycemia Ratio	10 week	The ratio of stress-to-on admission blood glucose was calculated

Secondary Outcome Measures

Name	Time	Method
Hematological indices	10 week	Concentration of hemoglobin (g/dL) and the value of mean corpuscular volume (fL)
Inflammatory markers	10 week	Concentration of c-reactive protein (mg/L)

Trial Locations

Locations (1)

College of Medicine, University of Diyala; 🇮🇶 Baqubah, Diyala, Iraq