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

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05864183
• Other study ID #: Soh-Med-23-04-20MS
• Status: Recruiting
• Start date: April 15, 2023
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: Sohag University
• Contact: Nermeen F Ezzat, resident
• Phone: 01273878007
• Email: nerminfathy[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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 .

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Diagnostic Test:
• HbA1c
HbA1c will be measured for all patients to minimize the risk of developing diabetes or its complications .
• lipid profile
lipid profile will be measured for all patients to minimize the risk of developing diabetes or its complications .
• CBC
CBC will be measured for all patients to minimize the risk of developing diabetes or its complications
• Alb/cr ratio
Alb/cr will be measured for all patients to minimize the risk of developing diabetes or its complications
• serum creatinine .
serum creatinine will be measured for all patients to minimize the risk of developing diabetes or its complications
• CRP
CRP will be measured for all patients to minimize the risk of developing diabetes or its complications
• urine analysis
urine analysis will be measured for all patients to minimize the risk of developing diabetes or its complications
• ECG
ECG will be done for all patients to minimize the risk of developing diabetes or its complications
• fundus examination
fundus examination will be done for all patients to minimize the risk of developing diabetes or its complications

Locations

Country	Name	City	State
Egypt	Sohag university hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months