Chronic Kidney DiseaseNCT07279922
What is the Role of Triglyceride-glucose Index as a Predictive Marker for Insulin Resistance in Pre Diabetic Chronic Kidney Disease Patients?
An observational study of Chronic Kidney Disease and Pre Diabetes, run by Assiut University.
Trial summary
The aim of this study is to evaluate the role of the triglyceride-glucose (TyG) index as a predictive marker for insulin resistance in pre-diabetic patients with chronic kidney disease (CKD), and to investigate its potential utility as a simple, non-invasive alternative to traditional insulin resistance assessment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Pre Diabetes
- What is being tested?
- Triglyceride-glucose index
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged ≥18 years with medical history free from renal dysfunction or with renal dysfunction (CKD stages 2_5 based on KDIGO guidelines)
Who may be able to join
- Adults aged ≥18 years
- Patients with medical history free from renal dysfunction
- Patients with renal dysfunction (CKD stages 25 based on KDIGO guidelines)
- No previous diagnosis of diabetes mellitus
- Provided informed consent
Who cannot join
- Known type 1 or type 2 diabetes mellitus
- Acute kidney injury
- Use of steroids or medications that affect glucose and lipid metabolism
- Pregnancy
- Active infections
- Malignancy
About this study
Official title: The Role of Triglyceride-glucose Index as a Predictive Marker for Insulin Resistance in Pre Diabetic Chronic Kidney Disease Patients.
The aim of this study is to evaluate the role of the triglyceride-glucose (TyG) index as a predictive marker for insulin resistance in pre-diabetic patients with chronic kidney disease (CKD), and to investigate its potential utility as a simple, non-invasive alternative to traditional insulin resistance assessment methods.
Read the detailed description
Diabetes mellitus remains a major public health challenge worldwide due to its increasing prevalence and associated complications, particularly when undiagnosed in its early stages. Early identification of individuals at high risk is essential for timely intervention to delay or prevent disease onset. Traditional diagnostic tools may miss early metabolic disturbances, necessitating more sensitive and accessible biomarkers.
The triglyceride-glucose (TyG) index, derived from fasting plasma triglycerides and glucose, has recently emerged as a simple, reliable, and cost-effective surrogate marker for insulin resistance. Its utility has been validated in multiple populations, showing strong associations with metabolic dysfunction and future development of diabetes.
Renal dysfunction is frequently associated with alterations in glucose and lipid metabolism, even before overt diabetes develops. However, the diagnostic accuracy of traditional risk markers may be compromised in the context of impaired kidney function. The TyG index offers potential advantages due to its independence from insulin measurements and ease of calculation.
Despite growing evidence on the predictive role of the TyG index, limited data exist regarding its performance across different levels of kidney function. Investigating its diagnostic value in patients with and without renal impairment may provide a valuable tool for early diabetes risk assessment and targeted preventive strategies.
- Conditions
- Chronic Kidney Disease, Pre Diabetes
- Being tested
- Triglyceride-glucose index
- Medical subject headings
- Renal Insufficiency, Chronic, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triglyceride-glucose indexDiagnostic test
Triglyceride-glucose index calculation according to TyG index=In[Triglycerides(mg/dl)×Fasting Glucose(mg/dl)/2]
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of TyG index
Diagnostic performance of TyG index in predicting prediabetics and diabetic patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Osama Ahmed Abd_elsamea, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279922
- Sponsor's protocol ID
- TyG-CKD
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Triglyceride-glucose Index as a Predictive Marker for Insulin Resistance in Pre Diabetic Chronic Kidney Disease Patients.
- ClinicalTrials.gov ID
- NCT07279922
- Acronym / sponsor ID
- TyG-CKD
- Conditions
- Chronic Kidney Disease, Pre Diabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 12 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.
The aim of this study is to evaluate the role of the triglyceride-glucose (TyG) index as a predictive marker for insulin resistance in pre-diabetic patients with chronic kidney disease (CKD), and to investigate its potential utility as a simple, non-invasive alternative to traditional insulin resistance assessment methods.
Detailed description
Diabetes mellitus remains a major public health challenge worldwide due to its increasing prevalence and associated complications, particularly when undiagnosed in its early stages. Early identification of individuals at high risk is essential for timely intervention to delay or prevent disease onset. Traditional diagnostic tools may miss early metabolic disturbances, necessitating more sensitive and accessible biomarkers.
The triglyceride-glucose (TyG) index, derived from fasting plasma triglycerides and glucose, has recently emerged as a simple, reliable, and cost-effective surrogate marker for insulin resistance. Its utility has been validated in multiple populations, showing strong associations with metabolic dysfunction and future development of diabetes.
Renal dysfunction is frequently associated with alterations in glucose and lipid metabolism, even before overt diabetes develops. However, the diagnostic accuracy of traditional risk markers may be compromised in the context of impaired kidney function. The TyG index offers potential advantages due to its independence from insulin measurements and ease of calculation.
Despite growing evidence on the predictive role of the TyG index, limited data exist regarding its performance across different levels of kidney function. Investigating its diagnostic value in patients with and without renal impairment may provide a valuable tool for early diabetes risk assessment and targeted preventive strategies.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged ≥18 years with medical history free from renal dysfunction or with renal dysfunction (CKD stages 2_5 based on KDIGO guidelines)
Key inclusion criteria (5 listed)
- Adults aged ≥18 years
- Patients with medical history free from renal dysfunction
- Patients with renal dysfunction (CKD stages 25 based on KDIGO guidelines)
- No previous diagnosis of diabetes mellitus
- Provided informed consent
Key exclusion criteria (6 listed)
- Known type 1 or type 2 diabetes mellitus
- Acute kidney injury
- Use of steroids or medications that affect glucose and lipid metabolism
- Pregnancy
- Active infections
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 |
|---|---|---|
| Triglyceride-glucose indexTriglyceride-glucose index calculation according to TyG index=In[Triglycerides(mg/dl)×Fasting Glucose(mg/dl)/2] | Diagnostic test | – |
Primary outcome
Diagnostic performance of TyG index
Time frame: 2 years
Diagnostic performance of TyG index in predicting prediabetics and diabetic patients.
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 12 Dec 2025.
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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 Chronic Kidney Disease and Pre Diabetes, 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 5 inclusion and 6 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 12 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?
Diagnostic performance of TyG index (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2025.