Variable Effects of Anti-diabetics on Stress Hyperglycemia Ratio

Study Overview
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Brief Summary
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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
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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

Official Title
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A Preliminary Clinical Study on the Effects of Oral Hypoglycemic Agents on the Stress Hyperglycemic Ratio in Type 2 Diabetes Patients in the Absence of Serious Illness

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Sitagliptin/metformin ( 50/500mg) Oral Tablet
* Drug: Empagliflozin/metformin(10/500mg) Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sitagliptin/metformin<br>Patients with T2D treated with sitagliptin/metformin (50/500mg) once daily for 10 weeks | Drug: Sitagliptin/metformin ( 50/500mg) Oral Tablet<br>* The drug was prescribed once daily per oral for 10 weeks<br>* Other names: Group I;|
| Empagliflozin/metformin<br>Patients with T2D treated with empagliflozin/metformin (10/500mg) once daily for 10 weeks | Drug: Empagliflozin/metformin(10/500mg) Oral Tablet<br>* The drug was prescribed once daily per oral for 10 weeks<br>* Other names: Group II;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress hyperglycemia Ratio | The ratio of stress-to-on admission blood glucose was calculated | 10 week | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Empagliflozin, Stress hyperglycemia ratio, Sitagliptin