Variable Effects of Anti-diabetics on Stress Hyperglycemia Ratio

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05822674
• Other study ID #: University of Diyala
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: April 2023
• Source: University of Diyala
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hyperglycemia
• Type 2 Diabetes

Intervention

Drug:
• Sitagliptin/metformin ( 50/500mg) Oral Tablet
The drug was prescribed once daily per oral for 10 weeks
• Empagliflozin/metformin(10/500mg) Oral Tablet
The drug was prescribed once daily per oral for 10 weeks

Locations

Country	Name	City	State
Iraq	College of Medicine, University of Diyala	Baqubah	Diyala

Sponsors (1)

Lead Sponsor	Collaborator
University of Diyala

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress hyperglycemia Ratio	The ratio of stress-to-on admission blood glucose was calculated	10 week
Secondary	Hematological indices	Concentration of hemoglobin (g/dL) and the value of mean corpuscular volume (fL)	10 week
Secondary	Inflammatory markers	Concentration of c-reactive protein (mg/L)	10 week