- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07259954
Prediabetes and Metabolic Parameters Among Young Adults at Assiut University Hospital
Prediabetes Among Young Adults and Its Relation to Metabolic Parameters in Persons Attending Assuit University Hospital
Study Overview
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- adults diagnosed with prediabetes
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group A impaired glucose tolerance_Group B - Impaired Fasting Glucose Group C - Impaired HbA1c
|
Participants will be classified into groups based on impaired fasting glucose, impaired post-prandial glucose, or impaired HbA1c according to ADA criteria
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between prediabetes subtypes and metabolic syndrome
Time Frame: At baseline (cross-sectional assessment during enrollment).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Factors affecting the correlation between prediabetes phenotypes and metabolic abnormalities (age, gender, family history, body physique, waist circumference and physical activity.
Time Frame: At baseline (cross-sectional assessment during enrollment)
|
Secondary Outcome 1 Title: Age Description: Participant age in years.
Unit of Measure: Years Time Frame: Baseline Secondary Outcome 2 Title: Sex Description: Participant sex as recorded at baseline.
Unit of Measure: Categorical Time Frame: Baseline Secondary Outcome 3 Title: Family history of diabetes Description: Presence of family history of diabetes in first-degree relatives.
Unit of Measure: Yes/No Time Frame: Baseline Secondary Outcome 4 Title: Weight Description: Body weight measured using a calibrated scale.
Unit of Measure: Kilograms Time Frame: Baseline Secondary Outcome 5 Title: Height Description: Participant height measured using a stadiometer.
Unit of Measure: Centimeters Time Frame: Baseline Secondary Outcome 6 Title: Body Mass Index (BMI) Description: BMI calculated as weight (kg) divided by height squared (m²).
Unit of Measure: kg/m² Time Frame: Baseline Secondary Outcome 7 Title: Waist circumference Description: Waist circumference measured using a non-stretchab
|
At baseline (cross-sectional assessment during enrollment)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- http://doi.org/10.1007/s00125-013-2902-4
- http://doi.org/10.1136/bmj.g4485
- http://doi.org/10.1007/s00125-009-1443-3
- http://doi.org/10.2337/dc08-1264
- http://doi.org/10.1016/j.diabres.2007.05.004
- http://doi.org/10.2337/diabetes.52.6.1475
- http://doi.org/10.1136/bmj.i5953
- http://doi.org/10.1056/NEJMoa012512
- http://doi.org/10.1016/S0140-6736(12)60525-X
- http://doi.org/10.2337/dc10-0679
- http://doi.org/10.2337/diacare.2951130
- http://doi.org/10.2337/dc07-9920
- http://doi.org/10.1016/S0140-6736(12)60283-9
- International Diabetes Federation. IDF Diabetes Atlas. 10th ed. Brussels: IDF; 2021. http://www.diabetesatlas.org
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUH-MED-PREDIAB-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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