Screening for Risk Factors of Prediabetes Among Adult Patients at Sohag University Hospital

NCT ID: NCT05864183

Last Updated: 2023-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-15

Study Completion Date

2023-12-31

Brief Summary

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* 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

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* 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

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PreDiabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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case group

prediabetic

HbA1c

Intervention Type DIAGNOSTIC_TEST

HbA1c will be measured for all patients to minimize the risk of developing diabetes or its complications .

lipid profile

Intervention Type DIAGNOSTIC_TEST

lipid profile will be measured for all patients to minimize the risk of developing diabetes or its complications .

CBC

Intervention Type DIAGNOSTIC_TEST

CBC will be measured for all patients to minimize the risk of developing diabetes or its complications

Alb/cr ratio

Intervention Type DIAGNOSTIC_TEST

Alb/cr will be measured for all patients to minimize the risk of developing diabetes or its complications

serum creatinine .

Intervention Type DIAGNOSTIC_TEST

serum creatinine will be measured for all patients to minimize the risk of developing diabetes or its complications

CRP

Intervention Type DIAGNOSTIC_TEST

CRP will be measured for all patients to minimize the risk of developing diabetes or its complications

urine analysis

Intervention Type DIAGNOSTIC_TEST

urine analysis will be measured for all patients to minimize the risk of developing diabetes or its complications

ECG

Intervention Type DIAGNOSTIC_TEST

ECG will be done for all patients to minimize the risk of developing diabetes or its complications

fundus examination

Intervention Type DIAGNOSTIC_TEST

fundus examination will be done for all patients to minimize the risk of developing diabetes or its complications

control group

non prediabetic

HbA1c

Intervention Type DIAGNOSTIC_TEST

HbA1c will be measured for all patients to minimize the risk of developing diabetes or its complications .

lipid profile

Intervention Type DIAGNOSTIC_TEST

lipid profile will be measured for all patients to minimize the risk of developing diabetes or its complications .

CBC

Intervention Type DIAGNOSTIC_TEST

CBC will be measured for all patients to minimize the risk of developing diabetes or its complications

Alb/cr ratio

Intervention Type DIAGNOSTIC_TEST

Alb/cr will be measured for all patients to minimize the risk of developing diabetes or its complications

serum creatinine .

Intervention Type DIAGNOSTIC_TEST

serum creatinine will be measured for all patients to minimize the risk of developing diabetes or its complications

CRP

Intervention Type DIAGNOSTIC_TEST

CRP will be measured for all patients to minimize the risk of developing diabetes or its complications

urine analysis

Intervention Type DIAGNOSTIC_TEST

urine analysis will be measured for all patients to minimize the risk of developing diabetes or its complications

ECG

Intervention Type DIAGNOSTIC_TEST

ECG will be done for all patients to minimize the risk of developing diabetes or its complications

fundus examination

Intervention Type DIAGNOSTIC_TEST

fundus examination will be done for all patients to minimize the risk of developing diabetes or its complications

Interventions

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HbA1c

HbA1c will be measured for all patients to minimize the risk of developing diabetes or its complications .

Intervention Type DIAGNOSTIC_TEST

lipid profile

lipid profile will be measured for all patients to minimize the risk of developing diabetes or its complications .

Intervention Type DIAGNOSTIC_TEST

CBC

CBC will be measured for all patients to minimize the risk of developing diabetes or its complications

Intervention Type DIAGNOSTIC_TEST

Alb/cr ratio

Alb/cr will be measured for all patients to minimize the risk of developing diabetes or its complications

Intervention Type DIAGNOSTIC_TEST

serum creatinine .

serum creatinine will be measured for all patients to minimize the risk of developing diabetes or its complications

Intervention Type DIAGNOSTIC_TEST

CRP

CRP will be measured for all patients to minimize the risk of developing diabetes or its complications

Intervention Type DIAGNOSTIC_TEST

urine analysis

urine analysis will be measured for all patients to minimize the risk of developing diabetes or its complications

Intervention Type DIAGNOSTIC_TEST

ECG

ECG will be done for all patients to minimize the risk of developing diabetes or its complications

Intervention Type DIAGNOSTIC_TEST

fundus examination

fundus examination will be done for all patients to minimize the risk of developing diabetes or its complications

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adult patient above 18 years old .

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Nermin Fathy Ezzat

internal medicine resident at faculty of medicine Sohag university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nermeen F Ezzat, resident

Role: CONTACT

01273878007

Adel A El sayed, professor

Role: CONTACT

01006677651

Facility Contacts

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Magdy M Amin, professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 22683128 (View on PubMed)

Beulens 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.

Reference Type BACKGROUND
PMID: 31766914 (View on PubMed)

Vas 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.

Reference Type RESULT
PMID: 28781065 (View on PubMed)

Other Identifiers

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Soh-Med-23-04-20MS

Identifier Type: -

Identifier Source: org_study_id

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