PreDiabetesNCT05864183
Screening for Risk Factors of Prediabetes Among Adult Patients at Sohag University Hospital
An observational study of PreDiabetes, run by Sohag University at 1 site in Egypt.
Trial summary
Prediabetes is an intermediate state of hyperglycemia with glycemic parameters above normal but below the diabetes threshold.. during the average 3 years of follow-up Prediabetes is diagnosed based on laboratory tests: fasting plasma glucose level (100-125 mg/dl) ;HbA1c, (5.7-6.4%) or plasma glucose level after an… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- HbA1c, lipid profile and CBC
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2023to Dec 2023
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients admitted to Sohag University hospital at period of admission 18 years or older wihe exclusion of patients known to be diabetics , pregnants , chronic depleting diseases patients , those who were taking drugs known to influence blood glucose levels e.g. metformin, thiazolidinedione and steroids.
Who may be able to join
- Adult patient above 18 years old .
Who cannot join
- all patients known to be diabetics .
- pregnancy .
- chronic depleting diseases,
- Those who were taking drugs known to influence blood glucose levels e.g. metformin, thiazolidinedione and steroids.
Trial locations and contacts
1 site in 1 country.
Adel A El sayed, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
Magdy M Amin, professor
About this study
Official title: Screening for Risk Factors of Prediabetes Among Adults Patients at Sohag University Hospital
- Prediabetes is an intermediate state of hyperglycemia with glycemic parameters above normal but below the diabetes threshold..
- during the average 3 years of follow-up Prediabetes is diagnosed based on laboratory tests: fasting plasma glucose level (100-125 mg/dl) ;HbA1c, (5.7-6.4%) or plasma glucose level after an oral glucose tolerance test ( 140-199 mg/dl).
- Reports estimate that more than 470 million people will have prediabetes by 2030.
- According to an expert panel of the American Diabetes Association, up to 70% of individuals with prediabetes will eventually develop diabetes.
- Observational evidence suggests as association between prediabetes and complications of diabetes such early nephropathy(10%) , small fiber neuropathy(18-25 %), early retinopathy (8-12%) and risk of macrovascular disease (52%) .
- Screening for prediabetes is designed to save lives or enhance an individual's quality of life by early detection so that screening will minimize the risk of developing diabetes or its complications .
Read the detailed description
- In this case control study we aim to screen for risk factors of prediabetes among adult patients to minimize the risk of developing diabetes or its complications .
- Prediabetes screening is also required to minimize medical costs such as hospitalization, outpatient care, surgery, medications, and laboratory test costs .
- Several studies had shown efficacy of lifestyle interventions in diabetes prevention by targeting obesity with increase in physical activity and dietary changes with a relative risk reduction of 40%-70% in adults with prediabetes ,also there is increasing evidence to prove the efficacy of pharmacotherapy in prevention of diabetes in adults with prediabetes
- Conditions
- PreDiabetes
- Being tested
- HbA1c, lipid profile, CBC, Alb/cr ratio, serum creatinine .
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HbA1cDiagnostic test
HbA1c will be measured for all patients to minimize the risk of developing diabetes or its complications .
lipid profileDiagnostic test
lipid profile will be measured for all patients to minimize the risk of developing diabetes or its complications .
CBCDiagnostic test
CBC will be measured for all patients to minimize the risk of developing diabetes or its complications
Alb/cr ratioDiagnostic test
Alb/cr will be measured for all patients to minimize the risk of developing diabetes or its complications
serum creatinine .Diagnostic test
serum creatinine will be measured for all patients to minimize the risk of developing diabetes or its complications
CRPDiagnostic test
CRP will be measured for all patients to minimize the risk of developing diabetes or its complications
urine analysisDiagnostic test
urine analysis will be measured for all patients to minimize the risk of developing diabetes or its complications
ECGDiagnostic test
ECG will be done for all patients to minimize the risk of developing diabetes or its complications
fundus examinationDiagnostic test
fundus examination will be done for all patients to minimize the risk of developing diabetes or its complications
| Study group | Role | What they receive |
|---|---|---|
| case group | prediabetic Receives: Diagnostic Test: HbA1c; Diagnostic Test: lipid profile; Diagnostic Test: CBC; Diagnostic Test: Alb/cr ratio; Diagnostic Test: serum creatinine .; Diagnostic Test: CRP; Diagnostic Test: urine analysis; Diagnostic Test: ECG; Diagnostic Test: fundus examination | |
| control group | non prediabetic Receives: Diagnostic Test: HbA1c; Diagnostic Test: lipid profile; Diagnostic Test: CBC; Diagnostic Test: Alb/cr ratio; Diagnostic Test: serum creatinine .; Diagnostic Test: CRP; Diagnostic Test: urine analysis; Diagnostic Test: ECG; Diagnostic Test: fundus examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between the measurement of HbA1c in normal non prediabetics and prediabetics at Sohag university hospital .
analysis of HbA1c measurements and compare the results in both groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start15 Apr 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermin Fathy Ezzat, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864183
- Sponsor's protocol ID
- Soh-Med-23-04-20MS
- Status last verified
- May 2023
- First submitted
- 19 Apr 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tabak AG, Herder C, Rathmann W, Brunner EJ, Kivimaki M. Prediabetes: a high-risk state for diabetes development. Lancet. 2012 Jun 16;379(9833):2279-90. doi: 10.1016/S0140-6736(12)60283-9. Epub 2012 Jun 9.
PubMed 22683128Beulens J, Rutters F, Ryden L, Schnell O, Mellbin L, Hart HE, Vos RC. Risk and management of pre-diabetes. Eur J Prev Cardiol. 2019 Dec;26(2_suppl):47-54. doi: 10.1177/2047487319880041.
PubMed 31766914Vas PRJ, Alberti KG, Edmonds ME. Prediabetes: moving away from a glucocentric definition. Lancet Diabetes Endocrinol. 2017 Nov;5(11):848-849. doi: 10.1016/S2213-8587(17)30234-6. Epub 2017 Aug 3. No abstract available.
PubMed 28781065
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Risk Factors of Prediabetes Among Adults Patients at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05864183
- Acronym / sponsor ID
- Soh-Med-23-04-20MS
- Conditions
- PreDiabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 May 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.
- Prediabetes is an intermediate state of hyperglycemia with glycemic parameters above normal but below the diabetes threshold..
- during the average 3 years of follow-up Prediabetes is diagnosed based on laboratory tests: fasting plasma glucose level (100-125 mg/dl) ;HbA1c, (5.7-6.4%) or plasma glucose level after an oral glucose tolerance test ( 140-199 mg/dl).
- Reports estimate that more than 470 million people will have prediabetes by 2030.
- According to an expert panel of the American Diabetes Association, up to 70% of individuals with prediabetes will eventually develop diabetes.
- Observational evidence suggests as association between prediabetes and complications of diabetes such early nephropathy(10%) , small fiber neuropathy(18-25 %), early retinopathy (8-12%) and risk of macrovascular disease (52%) .
- Screening for prediabetes is designed to save lives or enhance an individual's quality of life by early detection so that screening will minimize the risk of developing diabetes or its complications .
Detailed description
- In this case control study we aim to screen for risk factors of prediabetes among adult patients to minimize the risk of developing diabetes or its complications .
- Prediabetes screening is also required to minimize medical costs such as hospitalization, outpatient care, surgery, medications, and laboratory test costs .
- Several studies had shown efficacy of lifestyle interventions in diabetes prevention by targeting obesity with increase in physical activity and dietary changes with a relative risk reduction of 40%-70% in adults with prediabetes ,also there is increasing evidence to prove the efficacy of pharmacotherapy in prevention of diabetes in adults with prediabetes
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Diagnostic Test: HbA1c, Diagnostic Test: lipid profile, Diagnostic Test: CBC, Diagnostic Test: Alb/cr ratio, Diagnostic Test: serum creatinine ., Diagnostic Test: CRP, Diagnostic Test: urine analysis, Diagnostic Test: ECG, Diagnostic Test: fundus examinationprediabetic |
| control group | – | Diagnostic Test: HbA1c, Diagnostic Test: lipid profile, Diagnostic Test: CBC, Diagnostic Test: Alb/cr ratio, Diagnostic Test: serum creatinine ., Diagnostic Test: CRP, Diagnostic Test: urine analysis, Diagnostic Test: ECG, Diagnostic Test: fundus examinationnon prediabetic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to Sohag University hospital at period of admission 18 years or older wihe exclusion of patients known to be diabetics , pregnants , chronic depleting diseases patients , those who were taking drugs known to influence blood glucose levels e.g. metformin, thiazolidinedione and steroids.
Key inclusion criteria (1 listed)
- Adult patient above 18 years old .
Key exclusion criteria (4 listed)
- all patients known to be diabetics .
- pregnancy .
- chronic depleting diseases,
- Those who were taking drugs known to influence blood glucose levels e.g. metformin, thiazolidinedione and steroids.
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 |
|---|---|---|
| HbA1cHbA1c will be measured for all patients to minimize the risk of developing diabetes or its complications . | Diagnostic test | case group, control group |
| lipid profilelipid profile will be measured for all patients to minimize the risk of developing diabetes or its complications . | Diagnostic test | case group, control group |
| CBCCBC will be measured for all patients to minimize the risk of developing diabetes or its complications | Diagnostic test | case group, control group |
| Alb/cr ratioAlb/cr will be measured for all patients to minimize the risk of developing diabetes or its complications | Diagnostic test | case group, control group |
| serum creatinine .serum creatinine will be measured for all patients to minimize the risk of developing diabetes or its complications | Diagnostic test | case group, control group |
| CRPCRP will be measured for all patients to minimize the risk of developing diabetes or its complications | Diagnostic test | case group, control group |
| urine analysisurine analysis will be measured for all patients to minimize the risk of developing diabetes or its complications | Diagnostic test | case group, control group |
| ECGECG will be done for all patients to minimize the risk of developing diabetes or its complications | Diagnostic test | case group, control group |
| fundus examinationfundus examination will be done for all patients to minimize the risk of developing diabetes or its complications | Diagnostic test | case group, control group |
Primary outcome
comparison between the measurement of HbA1c in normal non prediabetics and prediabetics at Sohag university hospital .
Time frame: 6 months
analysis of HbA1c measurements and compare the results in both groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Background: PubMed 22683128Tabak AG, Herder C, Rathmann W, Brunner EJ, Kivimaki M. Prediabetes: a high-risk state for diabetes development. Lancet. 2012 Jun 16;379(9833):2279-90. doi: 10.1016/S0140-6736(12)60283-9. Epub 2012 Jun 9.
- Background: PubMed 31766914Beulens J, Rutters F, Ryden L, Schnell O, Mellbin L, Hart HE, Vos RC. Risk and management of pre-diabetes. Eur J Prev Cardiol. 2019 Dec;26(2_suppl):47-54. doi: 10.1177/2047487319880041.
- Results publication: PubMed 28781065Vas PRJ, Alberti KG, Edmonds ME. Prediabetes: moving away from a glucocentric definition. Lancet Diabetes Endocrinol. 2017 Nov;5(11):848-849. doi: 10.1016/S2213-8587(17)30234-6. Epub 2017 Aug 3. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Adel A El sayed, professor contact
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 PreDiabetes, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 May 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nermeen F Ezzat, resident (01273878007, nerminfathy@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison between the measurement of HbA1c in normal non prediabetics and prediabetics at Sohag university hospital . (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05864183, which also lists 3 linked publications.
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 18 May 2023.