Variable Effects of Anti-diabetics on Stress Hyperglycemia Ratio

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

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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Iraq
  • Diyala
    • Baqubah, Diyala, Iraq, 32001
      • College of Medicine, University of Diyala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Known cases of type 2 diabetes who were attending the diabetes centers and private clinics seeking for diabetes control and follow-up.

The authors discussed with the participants about the study design and outcomes

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sitagliptin/metformin; Patients with T2D treated with sitagliptin/metformin (50/500mg) once daily for 10 weeks	Drug: Sitagliptin/metformin ( 50/500mg) Oral Tablet; The drug was prescribed once daily per oral for 10 weeks; Other Names: Group I
Empagliflozin/metformin; Patients with T2D treated with empagliflozin/metformin (10/500mg) once daily for 10 weeks	Drug: Empagliflozin/metformin(10/500mg) Oral Tablet; The drug was prescribed once daily per oral for 10 weeks; Other Names: Group II

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Diyala
• Investigators: Study Director: Ismail Latif, The Dean College of Medicine, University of Diyal

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Empagliflozin; Sitagliptin; Stress hyperglycemia ratio
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Sodium-Glucose Transporter 2 Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Empagliflozin; Sitagliptin Phosphate
• Other Study ID Numbers: University of Diyala

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data of this study can be shared on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No