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

May 8, 2023 updated by: Nermin Fathy Ezzat, Sohag University

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Adel A El sayed, professor
  • Phone Number: 01006677651

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
case group
prediabetic
Diagnostic test: HbA1c
HbA1c will be measured for all patients to minimize the risk of developing diabetes or its complications .
Diagnostic test: lipid profile
lipid profile will be measured for all patients to minimize the risk of developing diabetes or its complications .
Diagnostic test: CBC
CBC will be measured for all patients to minimize the risk of developing diabetes or its complications
Diagnostic test: Alb/cr ratio
Alb/cr will be measured for all patients to minimize the risk of developing diabetes or its complications
Diagnostic test: serum creatinine .
serum creatinine will be measured for all patients to minimize the risk of developing diabetes or its complications
Diagnostic test: CRP
CRP will be measured for all patients to minimize the risk of developing diabetes or its complications
Diagnostic test: urine analysis
urine analysis will be measured for all patients to minimize the risk of developing diabetes or its complications
Diagnostic test: ECG
ECG will be done for all patients to minimize the risk of developing diabetes or its complications
Diagnostic test: fundus examination
fundus examination will be done for all patients to minimize the risk of developing diabetes or its complications
control group
non prediabetic
Diagnostic test: HbA1c
HbA1c will be measured for all patients to minimize the risk of developing diabetes or its complications .
Diagnostic test: lipid profile
lipid profile will be measured for all patients to minimize the risk of developing diabetes or its complications .
Diagnostic test: CBC
CBC will be measured for all patients to minimize the risk of developing diabetes or its complications
Diagnostic test: Alb/cr ratio
Alb/cr will be measured for all patients to minimize the risk of developing diabetes or its complications
Diagnostic test: serum creatinine .
serum creatinine will be measured for all patients to minimize the risk of developing diabetes or its complications
Diagnostic test: CRP
CRP will be measured for all patients to minimize the risk of developing diabetes or its complications
Diagnostic test: urine analysis
urine analysis will be measured for all patients to minimize the risk of developing diabetes or its complications
Diagnostic test: ECG
ECG will be done for all patients to minimize the risk of developing diabetes or its complications
Diagnostic test: fundus examination
fundus examination will be done for all patients to minimize the risk of developing diabetes or its complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-04-20MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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