Type 2 DiabetesNCT05822674
Variable Effects of Anti-diabetics on Stress Hyperglycemia Ratio
An observational study of Type 2 Diabetes, run by University of Diyala at 1 site in Iraq.
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… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Sitagliptin/metformin ( 50/500mg) Oral Tablet and Empagliflozin/metformin(10/500mg) Oral Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2022to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Age ≥35 years
- Diagnosis of Type 2 diabetes
- Absence of serious illnesses
- No evidence of trauma
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iraq1 site
College of Medicine, University of Diyala
Baqubah, Diyala Governorate, 32001
About this study
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
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
Read the 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
- Conditions
- Type 2 Diabetes
- Being tested
- Sitagliptin/metformin ( 50/500mg) Oral Tablet, Empagliflozin/metformin(10/500mg) Oral Tablet
- Keywords
- Stress hyperglycemia ratio, Sitagliptin, Empagliflozin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitagliptin/metformin ( 50/500mg) Oral TabletDrug
Also called Group I
The drug was prescribed once daily per oral for 10 weeks
Empagliflozin/metformin(10/500mg) Oral TabletDrug
Also called Group II
The drug was prescribed once daily per oral for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin/metformin | Patients with T2D treated with sitagliptin/metformin (50/500mg) once daily for 10 weeks Receives: Drug: Sitagliptin/metformin ( 50/500mg) Oral Tablet | |
| Empagliflozin/metformin | Patients with T2D treated with empagliflozin/metformin (10/500mg) once daily for 10 weeks Receives: Drug: Empagliflozin/metformin(10/500mg) Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress hyperglycemia Ratio
The ratio of stress-to-on admission blood glucose was calculated
Measured: 10 week
Secondary outcomes (2)
Hematological indices
Concentration of hemoglobin (g/dL) and the value of mean corpuscular volume (fL)
Measured: 10 week
Inflammatory markers
Concentration of c-reactive protein (mg/L)
Measured: 10 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Diyala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Salih Mohamad Al-Nimer, University of Diyala
- Investigators
- Ismail Latif, Study director, The Dean College of Medicine, University of Diyal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822674
- Sponsor's protocol ID
- University of Diyala
- Status last verified
- Apr 2023
- First submitted
- 8 Mar 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data of this study can be shared on request
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05822674
- Acronym / sponsor ID
- University of Diyala
- Conditions
- Type 2 Diabetes
- Keywords
- Stress hyperglycemia ratio, Sitagliptin, Empagliflozin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of DiyalaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin/metformin | – | Drug: Sitagliptin/metformin ( 50/500mg) Oral TabletPatients with T2D treated with sitagliptin/metformin (50/500mg) once daily for 10 weeks |
| Empagliflozin/metformin | – | Drug: Empagliflozin/metformin(10/500mg) Oral TabletPatients with T2D treated with empagliflozin/metformin (10/500mg) once daily for 10 weeks |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Age ≥35 years
- Diagnosis of Type 2 diabetes
- Absence of serious illnesses
- No evidence of trauma
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sitagliptin/metformin ( 50/500mg) Oral TabletAlso: Group IThe drug was prescribed once daily per oral for 10 weeks | Drug | Sitagliptin/metformin |
| Empagliflozin/metformin(10/500mg) Oral TabletAlso: Group IIThe drug was prescribed once daily per oral for 10 weeks | Drug | Empagliflozin/metformin |
Primary outcome
Stress hyperglycemia Ratio
Time frame: 10 week
The ratio of stress-to-on admission blood glucose was calculated
2 secondary outcomes
Hematological indices
Time frame: 10 week
Inflammatory markers
Time frame: 10 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: Undecided. The data of this study can be shared on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismail Latif study director
The Dean College of Medicine, University of Diyal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by University of Diyala at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress hyperglycemia Ratio (time frame: 10 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.