Variable Effects of Anti-diabetics on Stress Hyperglycemia Ratio

NCT05822674 | Completed DMC

• 1 other identifier: University of Diyala
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes

Keywords

Stress hyperglycemia ratio; Sitagliptin; Empagliflozin

Outcome Measures

Primary Outcomes (1)

• Stress hyperglycemia Ratio

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

  10 week

Secondary Outcomes (2)

• Hematological indices

  10 week

• Inflammatory markers

  10 week

Study Arms (2)

Sitagliptin/metformin

Patients with T2D treated with sitagliptin/metformin (50/500mg) once daily for 10 weeks

Drug: Sitagliptin/metformin ( 50/500mg) Oral Tablet

Empagliflozin/metformin

Patients with T2D treated with empagliflozin/metformin (10/500mg) once daily for 10 weeks

Drug: Empagliflozin/metformin(10/500mg) Oral Tablet

Interventions

Sitagliptin/metformin ( 50/500mg) Oral Tablet DRUG

The drug was prescribed once daily per oral for 10 weeks

Also known as: Group I

Sitagliptin/metformin

Empagliflozin/metformin(10/500mg) Oral Tablet DRUG

The drug was prescribed once daily per oral for 10 weeks

Also known as: Group II

Empagliflozin/metformin

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age ≥35 years
• Diagnosis of Type 2 diabetes
• Absence of serious illnesses
• No evidence of trauma

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Diyala: lead

Study Sites (1)

College of Medicine, University of Diyala

Baqubah, Diyala Governorate, 32001, Iraq

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Metformin; Tablets; empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Biguanides; Guanidines; Amidines; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Ismail Latif

  The Dean College of Medicine, University of Diyal

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Professor

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 21, 2023
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: February 1, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

IR (1)