PreDiabetesNCT07259954
Prediabetes and Metabolic Parameters Among Young Adults at Assiut University Hospital
An observational study of PreDiabetes, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- adults diagnosed with prediabetes
Who cannot join
- 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
About this study
Official title: Prediabetes Among Young Adults and Its Relation to Metabolic Parameters in Persons Attending Assuit University Hospital
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.
- Conditions
- PreDiabetes
- Being tested
- No intervention
- Keywords
- Predabetes
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Participants will be classified into groups based on impaired fasting glucose, impaired post-prandial glucose, or impaired HbA1c according to ADA criteria
| Study group | Role | What they receive |
|---|---|---|
| Group A impaired glucose tolerance_Group B - Impaired Fasting Glucose Group C - Impaired HbA1c | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: 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.
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
Measured: At baseline (cross-sectional assessment during enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Gamal Ali Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259954
- Sponsor's protocol ID
- AUH-MED-PREDIAB-2025
- Status last verified
- Nov 2025
- First submitted
- 14 Sep 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediabetes Among Young Adults and Its Relation to Metabolic Parameters in Persons Attending Assuit University Hospital
- ClinicalTrials.gov ID
- NCT07259954
- Acronym / sponsor ID
- AUH-MED-PREDIAB-2025
- Conditions
- PreDiabetes
- Keywords
- Predabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A impaired glucose tolerance_Group B - Impaired Fasting Glucose Group C - Impaired HbA1c | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- adults diagnosed with prediabetes
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionParticipants will be classified into groups based on impaired fasting glucose, impaired post-prandial glucose, or impaired HbA1c according to ADA criteria | Other | Group A impaired glucose tolerance_Group B - Impaired Fasting Glucose Group C - Impaired HbA1c |
Primary outcome
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 (%)
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Backgroundhttp://doi.org/10.1007/s00125-013-2902-4
- Backgroundhttp://doi.org/10.1136/bmj.g4485
- Backgroundhttp://doi.org/10.1007/s00125-009-1443-3
- Backgroundhttp://doi.org/10.2337/dc08-1264
- Backgroundhttp://doi.org/10.1016/j.diabres.2007.05.004
- Backgroundhttp://doi.org/10.2337/diabetes.52.6.1475
- Backgroundhttp://doi.org/10.1136/bmj.i5953
- Backgroundhttp://doi.org/10.1056/NEJMoa012512
- Backgroundhttp://doi.org/10.1016/S0140-6736(12)60525-X
- Backgroundhttp://doi.org/10.2337/dc10-0679
- Backgroundhttp://doi.org/10.2337/diacare.2951130
- Backgroundhttp://doi.org/10.2337/dc07-9920
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of PreDiabetes, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between prediabetes subtypes and metabolic syndrome (time frame: At baseline (cross-sectional assessment during enrollment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07259954, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.