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Completed

NCT Number: NCT05822674

Variable Effects of Anti-diabetics on Stress Hyperglycemia Ratio

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

College of Medicine, University of Diyala

Baqubah, Diyala Governorate, 32001, Iraq

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sitagliptin/metformin ( 50/500mg) Oral Tablet

Drug

The drug was prescribed once daily per oral for 10 weeks

Other names: Group I

Empagliflozin/metformin(10/500mg) Oral Tablet

Drug

The drug was prescribed once daily per oral for 10 weeks

Other names: Group II

Primary outcomes

  1. Stress hyperglycemia Ratio

    Time frame: 10 week

    The ratio of stress-to-on admission blood glucose was calculated

Secondary outcomes

  1. Hematological indices

    Time frame: 10 week

    Concentration of hemoglobin (g/dL) and the value of mean corpuscular volume (fL)

  2. Inflammatory markers

    Time frame: 10 week

    Concentration of c-reactive protein (mg/L)

Sponsors and collaborators

Lead sponsor

University of Diyala

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 21, 2023
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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