NCT05864183

Brief 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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

April 19, 2023

Last Update Submit

May 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

case group

prediabetic

Diagnostic Test: HbA1cDiagnostic Test: lipid profileDiagnostic Test: CBCDiagnostic Test: Alb/cr ratioDiagnostic Test: serum creatinine .Diagnostic Test: CRPDiagnostic Test: urine analysisDiagnostic Test: ECGDiagnostic Test: fundus examination

control group

non prediabetic

Diagnostic Test: HbA1cDiagnostic Test: lipid profileDiagnostic Test: CBCDiagnostic Test: Alb/cr ratioDiagnostic Test: serum creatinine .Diagnostic Test: CRPDiagnostic Test: urine analysisDiagnostic Test: ECGDiagnostic Test: fundus examination

Interventions

HbA1cDIAGNOSTIC_TEST

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

case groupcontrol group
lipid profileDIAGNOSTIC_TEST

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

case groupcontrol group
CBCDIAGNOSTIC_TEST

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

case groupcontrol group
Alb/cr ratioDIAGNOSTIC_TEST

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

case groupcontrol group
serum creatinine .DIAGNOSTIC_TEST

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

case groupcontrol group
CRPDIAGNOSTIC_TEST

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

case groupcontrol group
urine analysisDIAGNOSTIC_TEST

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

case groupcontrol group
ECGDIAGNOSTIC_TEST

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

case groupcontrol group
fundus examinationDIAGNOSTIC_TEST

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

case groupcontrol group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Adult patient above 18 years old .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

  • 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.

    PMID: 22683128BACKGROUND
  • 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.

    PMID: 31766914BACKGROUND
  • 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.

MeSH Terms

Conditions

Prediabetic State

Interventions

UrinalysisElectrocardiography

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalInvestigative TechniquesHeart Function TestsDiagnostic Techniques, CardiovascularElectrodiagnosis

Central Study Contacts

Nermeen F Ezzat, resident

CONTACT

Adel A El sayed, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
internal medicine resident at faculty of medicine Sohag university

Study Record Dates

First Submitted

April 19, 2023

First Posted

May 18, 2023

Study Start

April 15, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

May 18, 2023

Record last verified: 2023-05

Locations