Diabetes Mellitus, Type 2NCT05602532
Triglyceride-Glucose Index in Diabetic Nephropathy in Type 2diaberes Mellitus Patients
An observational study of Diabetes Mellitus, Type 2, run by Assiut University.
Trial summary
The aim of the present study is to investigate the associations between the TyG index and diabetic nephropathy in patients with type2 DM . Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 25 to 75 years
- All sexes
- Adult, Older adult
Study population: There will be no risk for the patients during the study Confidentiality will be assured. The participants will be informed about the research and they will hsve the right to refuse to participate. Written consents will be obtained from all the participants; illiterate participants will give their consent by fingerprints.
Who may be able to join
- patients with type 2 DM
Who cannot join
- (1) Individuals with obstructive uropathy, severe heart failure, stroke, liver disease, cancer, autoimmune disease (2) Pregnant woman. (3)End stage renal disease patients on dialysis ( glomerular filtration rate <15 mL/min/1.73 m2) or renal transplantation.
- Type 1 Diabetic patient. (5) Albuminuria due to non-diabetic renal disease
Trial locations and contacts
No sites are listed yet.
About this study
The aim of the present study is to investigate the associations between the TyG index and diabetic nephropathy in patients with type2 DM .
Read the detailed description
the triglyceride-glucose (TyG) index was proposed as a simple and reliable surrogate marker of IR, and it has been reported to be closely correlated with the HOMA-IR index. The TyG index has the advantage of being applicable in clinical practice since both triglyceride and glucose levels are routinely measured and the cost of these measurements is low.
- Conditions
- Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
TyG index in type 2diaberes Mellitus
Detecting the association between the TyG index and diabetic nephropathy in type 2 diabetes
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Abo Elyosr Garhey Yonis, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602532
- Sponsor's protocol ID
- TYG index in DN in type 2 DM
- Status last verified
- Oct 2022
- First submitted
- 28 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zheng Y, Ley SH, Hu FB. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nat Rev Endocrinol. 2018 Feb;14(2):88-98. doi: 10.1038/nrendo.2017.151. Epub 2017 Dec 8.
PubMed 29219149Beckman JA, Creager MA, Libby P. Diabetes and atherosclerosis: epidemiology, pathophysiology, and management. JAMA. 2002 May 15;287(19):2570-81. doi: 10.1001/jama.287.19.2570.
PubMed 12020339Yamagishi S, Imaizumi T. Diabetic vascular complications: pathophysiology, biochemical basis and potential therapeutic strategy. Curr Pharm Des. 2005;11(18):2279-99. doi: 10.2174/1381612054367300.
PubMed 16022668Liang S, Cai GY, Chen XM. Clinical and pathological factors associated with progression of diabetic nephropathy. Nephrology (Carlton). 2017 Dec;22 Suppl 4:14-19. doi: 10.1111/nep.13182.
PubMed 29155497Lee MY, Hsiao PJ, Huang JC, Hsu WH, Chen SC, Chang JM, Shin SJ. ASSOCIATIONS BETWEEN TRIGLYCERIDE/HIGH-DENSITY LIPOPROTEIN CHOLESTEROL RATIO AND MICRO- AND MACROANGIOPATHIES IN TYPE 2 DIABETES MELLITUS. Endocr Pract. 2018 Jul;24(7):615-621. doi: 10.4158/EP-2017-0254.
PubMed 30048164
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triglyceride-Glucose Index in Diabetic Nephropathy in Type 2diaberes Mellitus Patients
- ClinicalTrials.gov ID
- NCT05602532
- Acronym / sponsor ID
- TYG index in DN in type 2 DM
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 2 Nov 2022 (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 the present study is to investigate the associations between the TyG index and diabetic nephropathy in patients with type2 DM .
Detailed description
the triglyceride-glucose (TyG) index was proposed as a simple and reliable surrogate marker of IR, and it has been reported to be closely correlated with the HOMA-IR index. The TyG index has the advantage of being applicable in clinical practice since both triglyceride and glucose levels are routinely measured and the cost of these measurements is low.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- There will be no risk for the patients during the study Confidentiality will be assured. The participants will be informed about the research and they will hsve the right to refuse to participate. Written consents will be obtained from all the participants; illiterate participants will give their consent by fingerprints.
Key inclusion criteria (1 listed)
- patients with type 2 DM
Key exclusion criteria (2 listed)
- (1) Individuals with obstructive uropathy, severe heart failure, stroke, liver disease, cancer, autoimmune disease (2) Pregnant woman. (3)End stage renal disease patients on dialysis ( glomerular filtration rate <15 mL/min/1.73 m2) or renal transplantation.
- Type 1 Diabetic patient. (5) Albuminuria due to non-diabetic renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TyG index in type 2diaberes Mellitus
Time frame: Baseline
Detecting the association between the TyG index and diabetic nephropathy in type 2 diabetes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Background: PubMed 29219149Zheng Y, Ley SH, Hu FB. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nat Rev Endocrinol. 2018 Feb;14(2):88-98. doi: 10.1038/nrendo.2017.151. Epub 2017 Dec 8.
- Background: PubMed 12020339Beckman JA, Creager MA, Libby P. Diabetes and atherosclerosis: epidemiology, pathophysiology, and management. JAMA. 2002 May 15;287(19):2570-81. doi: 10.1001/jama.287.19.2570.
- Background: PubMed 16022668Yamagishi S, Imaizumi T. Diabetic vascular complications: pathophysiology, biochemical basis and potential therapeutic strategy. Curr Pharm Des. 2005;11(18):2279-99. doi: 10.2174/1381612054367300.
- Background: PubMed 29155497Liang S, Cai GY, Chen XM. Clinical and pathological factors associated with progression of diabetic nephropathy. Nephrology (Carlton). 2017 Dec;22 Suppl 4:14-19. doi: 10.1111/nep.13182.
- Background: PubMed 30048164Lee MY, Hsiao PJ, Huang JC, Hsu WH, Chen SC, Chang JM, Shin SJ. ASSOCIATIONS BETWEEN TRIGLYCERIDE/HIGH-DENSITY LIPOPROTEIN CHOLESTEROL RATIO AND MICRO- AND MACROANGIOPATHIES IN TYPE 2 DIABETES MELLITUS. Endocr Pract. 2018 Jul;24(7):615-621. doi: 10.4158/EP-2017-0254.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, 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 2 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya Abo Eyosr Garhey (01092606888, Ayayosry285@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TyG index in type 2diaberes Mellitus (time frame: Baseline). 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 NCT05602532, which also lists 5 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 Nov 2022.