NCT07259954

Brief Summary

Prediabetes is a major public health problem that increases the risk of developing type 2 diabetes mellitus and cardiovascular complications. Young adults represent an important age group in which early detection and intervention may prevent progression of the disease. The present study aims to identify factors associated with prediabetes and metabolic complications, and classify individuals based on clinical and biochemical profiles according to insulin resistance, dyslipidemia and fatty liver. This is an observational, cross-sectional study that will be conducted at Assiut University Hospital. Data will be collected through clinical examination, laboratory investigations, and assessment of metabolic profiles.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
21mo left

Started Dec 2025

Typical duration for all trials

Status
not yet recruiting

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 Progress20%
Dec 2025Feb 2028

First Submitted

Initial submission to the registry

September 14, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

September 14, 2025

Last Update Submit

November 28, 2025

Conditions

PreDiabetes

Keywords

Predabetes

Outcome Measures

Primary Outcomes (1)

  • Correlation between prediabetes subtypes and metabolic syndrome

    Primary Outcome Title: Correlation between prediabetes phenotypes and metabolic syndrome Outcome Measure: Prevalence (%) of metabolic syndrome within each prediabetes phenotype (IFG, IGT, combined IFG/IGT, elevated HbA1c). Description: Metabolic syndrome will be assessed at baseline according to the IDF definition. Participants will be classified into prediabetes phenotypes, and the proportion of individuals meeting metabolic syndrome criteria within each phenotype will be recorded. Time Frame: Baseline Unit of Measure: Percentage (%)

    At baseline (cross-sectional assessment during enrollment).

Secondary Outcomes (1)

  • Factors affecting the correlation between prediabetes phenotypes and metabolic abnormalities (age, gender, family history, body physique, waist circumference and physical activity.

    At baseline (cross-sectional assessment during enrollment)

Study Arms (1)

Group A impaired glucose tolerance_Group B - Impaired Fasting Glucose Group C - Impaired HbA1c

Other: No intervention

Interventions

No interventionOTHER

Participants will be classified into groups based on impaired fasting glucose, impaired post-prandial glucose, or impaired HbA1c according to ADA criteria

Group A impaired glucose tolerance_Group B - Impaired Fasting Glucose Group C - Impaired HbA1c

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of young adults aged 18-40 years attending outpatient clinics at Assiut University Hospital. Participants will be screened for prediabetes using fasting plasma glucose, 2-hour postprandial glucose, and HbA1c tests. Only individuals diagnosed with prediabetes according to ADA criteria (impaired fasting glucose, impaired glucose tolerance, or elevated HbA1c) will be included

You may qualify if:

  • adults diagnosed with prediabetes

You may not qualify if:

  • previous diagnosis of overt diabetes
  • other causes of CKD (e.g. urinary tract infection)
  • other causes of liver disease (e.g. HBV infection),
  • use of medications that alter glucose or lipid metabolism (e.g. corticosteroids),
  • current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • http://doi.org/10.1007/s00125-013-2902-4

    BACKGROUND

  • http://doi.org/10.1136/bmj.g4485

    BACKGROUND

  • http://doi.org/10.1007/s00125-009-1443-3

    BACKGROUND

  • http://doi.org/10.2337/dc08-1264

    BACKGROUND

  • http://doi.org/10.1016/j.diabres.2007.05.004

    BACKGROUND

  • http://doi.org/10.2337/diabetes.52.6.1475

    BACKGROUND

  • http://doi.org/10.1136/bmj.i5953

    BACKGROUND

  • http://doi.org/10.1056/NEJMoa012512

    BACKGROUND

  • http://doi.org/10.1016/S0140-6736(12)60525-X

    BACKGROUND

  • http://doi.org/10.2337/dc10-0679

    BACKGROUND

  • http://doi.org/10.2337/diacare.2951130

    BACKGROUND

  • http://doi.org/10.2337/dc07-9920

    BACKGROUND

  • http://doi.org/10.1016/S0140-6736(12)60283-9

    BACKGROUND

  • International Diabetes Federation. IDF Diabetes Atlas. 10th ed. Brussels: IDF; 2021. http://www.diabetesatlas.org

    BACKGROUND

Related Links

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal medicine ,assuit university hospital

Study Record Dates

First Submitted

September 14, 2025

First Posted

December 2, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share