Diabetic NephropathyNCT07476248
The Non-high-density Lipoprotein Cholesterol (Non-HDL-C) to High-density Lipoprotein Cholesterol (HDL-C) Ratio (NHHR) and Its Association With Occurrence of Diabetic Nephropathy in Patients With Diabetes Mellitus
An observational study of Diabetic Nephropathy and Dyslipidemia, run by Assiut University.
Trial summary
The study aims to examine the relationship between the non-high-density lipoprotein cholesterol-to-high-density lipoprotein cholesterol ratio (NHHR) and CKD in patients with DM. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Nephropathy, Dyslipidemia
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with DM attending the internal medicine outpatient clinics and inpatient department.
Who may be able to join
- Adults aged ≥18 years
- Diagnosed cases of diabetes mellitus (Type 1 or Type 2), with or without diabetic nephropathy
- Willingness to participate and provide informed consent
Who cannot join
- Known non-diabetic causes of chronic kidney disease
- Acute kidney injury
- Chronic inflammatory or autoimmune diseases
- Current use of medications known to significantly alter lipid metabolism (other than standard lipid-lowering therapy, if applicable)
- End-stage renal disease patients on dialysis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The study aims to examine the relationship between the non-high-density lipoprotein cholesterol-to-high-density lipoprotein cholesterol ratio (NHHR) and CKD in patients with DM.
Read the detailed description
The study will include adult participants recruited from outpatient clinics and inpatient departments. Participants will be classified into the following groups:
- Diabetes Mellitus without Diabetic Nephropathy (DM group) : Patients with diabetes mellitus who have no evidence of diabetic nephropathy will be defined by a normal urinary albumin-to-creatinine ratio (UACR) and preserved renal function.
- Diabetic Nephropathy group (DN group) :
Patients with diabetes mellitus and diabetic nephropathy will be defined by the presence of elevated UACR and/or impaired renal function as assessed by estimated glomerular filtration rate (eGFR).
Subgroup Analysis :
Within the diabetic nephropathy group, further subgroup analyses will be performed to assess differences in NHHR according to:
Type of diabetes (Type 1 vs. Type 2 diabetes mellitus) Stages of chronic kidney disease (CKD) are classified based on KDIGO definitions of CKD based on estimated GFR and albuminuria.
Type of the study: Comparative cross-sectional study
- Conditions
- Diabetic Nephropathy, Dyslipidemia
- Keywords
- Chronic kidney disease ( CKD ), Diabetes mellitus type 1, Diabetes mellitus type 2
- Medical subject headings
- Diabetic Nephropathies, Dyslipidemias, Renal Insufficiency, Chronic, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Mellitus without Diabetic Nephropathy (DM group) | Patients with diabetes mellitus who have no evidence of diabetic nephropathy will be defined by a normal urinary albumin-to-creatinine ratio (UACR) and preserved renal function. | |
| Diabetic Nephropathy group (DN group) | Patients with diabetes mellitus and diabetic nephropathy will be defined by the presence of elevated UACR and/or impaired renal function as assessed by estimated glomerular filtration rate (eGFR). And within the diabetic nephropathy group, further subgroup analyses will be performed to assess differences in NHHR according to: 1. Type of diabetes (Type 1 vs. Type 2 diabetes mellitus) 2. Stages of chronic kidney disease (CKD) are classified based on KDIGO definitions of CKD based on estimated GFR and albuminuria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between the non-high-density lipoprotein cholesterol-to-high-density lipoprotein cholesterol ratio (NHHR) and the presence of diabetic nephropathy.
Diabetic nephropathy defined as urinary albumin-to-creatinine ratio (UACR) ≥30 mg/g and/or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m², measured at enrollment. The non-HDL cholesterol to HDL cholesterol ratio (NHHR) will be calculated from fasting lipid profile obtained at the same visit.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathyStudies 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragaey Edward Riad, Assiut University
- Investigators
- Ahmed Mohamed Ashmawy, Professor, Principal investigator, Assiut UniversityNoha Gamal Abdel-Malek, Assistant lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476248
- Sponsor's protocol ID
- NHHR in Diabetic nephropathy
- Status last verified
- Feb 2026
- First submitted
- 12 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang L, Fan D, Zhu T, Geng L, Gan L, Ou S, Yin D. The ratio of non-high-density lipoprotein cholesterol to high-density lipoprotein cholesterol is associated with diabetic kidney disease: A cross-sectional study. PLoS One. 2024 Nov 27;19(11):e0311620. doi: 10.1371/journal.pone.0311620. eCollection 2024.
PubMed 39602386Tan MY, Weng L, Yang ZH, Zhu SX, Wu S, Su JH. The association between non-high-density lipoprotein cholesterol to high-density lipoprotein cholesterol ratio with type 2 diabetes mellitus: recent findings from NHANES 2007-2018. Lipids Health Dis. 2024 May 21;23(1):151. doi: 10.1186/s12944-024-02143-8.
PubMed 38773578Su X, Rao H, Zhao C, Wu J, Zhang X, Li D. Association between the non-high-density lipoprotein cholesterol to high-density lipoprotein cholesterol ratio and mortality among hypertension patients. Sci Rep. 2025 Feb 19;15(1):6012. doi: 10.1038/s41598-025-88539-7.
PubMed 39972003Pan X, Lin X, Huang X, Xu J, Ye L, Zhang T, Hu S, Jiang H, Ren Y, Shan PF. The Burden of Diabetes-Related Chronic Kidney Disease in China From 1990 to 2019. Front Endocrinol (Lausanne). 2022 Jun 15;13:892860. doi: 10.3389/fendo.2022.892860. eCollection 2022.
PubMed 35784566Lokpo SY, Laryea R, Osei-Yeboah J, Owiredu WKBA, Ephraim RKD, Adejumo EN, Ametepe S, Appiah M, Peter N, Affrim P, Kwadzokpui PK, Abeka OK. The pattern of dyslipidaemia and factors associated with elevated levels of non-HDL-cholesterol among patients with type 2 diabetes mellitus in the Ho municipality: A cross sectional study. Heliyon. 2022 Aug 17;8(8):e10279. doi: 10.1016/j.heliyon.2022.e10279. eCollection 2022 Aug.
PubMed 36046539Liu C, Dhindsa D, Almuwaqqat Z, Ko YA, Mehta A, Alkhoder AA, Alras Z, Desai SR, Patel KJ, Hooda A, Wehbe M, Sperling LS, Sun YV, Quyyumi AA. Association Between High-Density Lipoprotein Cholesterol Levels and Adverse Cardiovascular Outcomes in High-risk Populations. JAMA Cardiol. 2022 Jul 1;7(7):672-680. doi: 10.1001/jamacardio.2022.0912.
PubMed 35583863Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.
PubMed 19414839ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 1. Improving Care and Promoting Health in Populations: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Supple 1):S10-S18. doi: 10.2337/dc23-S001.
PubMed 36507639Chen X, Liang M, Zhang J, Xu C, Chen L, Hu R, Zhong J. The Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) to HDL-C Ratio (NHHR) and Its Association with Chronic Kidney Disease in Chinese Adults with Type 2 Diabetes: A Preliminary Study. Nutrients. 2025 Mar 24;17(7):1125. doi: 10.3390/nu17071125.
PubMed 40218883Chan JCN, Lim LL, Wareham NJ, Shaw JE, Orchard TJ, Zhang P, Lau ESH, Eliasson B, Kong APS, Ezzati M, Aguilar-Salinas CA, McGill M, Levitt NS, Ning G, So WY, Adams J, Bracco P, Forouhi NG, Gregory GA, Guo J, Hua X, Klatman EL, Magliano DJ, Ng BP, Ogilvie D, Panter J, Pavkov M, Shao H, Unwin N, White M, Wou C, Ma RCW, Schmidt MI, Ramachandran A, Seino Y, Bennett PH, Oldenburg B, Gagliardino JJ, Luk AOY, Clarke PM, Ogle GD, Davies MJ, Holman RR, Gregg EW. The Lancet Commission on diabetes: using data to transform diabetes care and patient lives. Lancet. 2021 Dec 19;396(10267):2019-2082. doi: 10.1016/S0140-6736(20)32374-6. Epub 2020 Nov 12. No abstract available.
PubMed 33189186Achila OO, Fessahye N, Mengistu ST, Habtemikael NT, Werke WY, Zemichael FT, Leghese HN, Weldegegish TA, Tekeste TH, Garoy EY. A community based cross sectional study on the prevalence of dyslipidemias and 10 years cardiovascular risk scores in adults in Asmara, Eritrea. Sci Rep. 2022 Apr 2;12(1):5567. doi: 10.1038/s41598-022-09446-9.
PubMed 35368036
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Non-high-density Lipoprotein Cholesterol (Non-HDL-C) to High-density Lipoprotein Cholesterol (HDL-C) Ratio (NHHR) and Its Association With Occurrence of Diabetic Nephropathy in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07476248
- Acronym / sponsor ID
- NHHR in Diabetic nephropathy
- Conditions
- Diabetic Nephropathy, Dyslipidemia
- Keywords
- Chronic kidney disease ( CKD ), Diabetes mellitus type 1, Diabetes mellitus type 2
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Mar 2026 (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 study aims to examine the relationship between the non-high-density lipoprotein cholesterol-to-high-density lipoprotein cholesterol ratio (NHHR) and CKD in patients with DM.
Detailed description
The study will include adult participants recruited from outpatient clinics and inpatient departments. Participants will be classified into the following groups:
- Diabetes Mellitus without Diabetic Nephropathy (DM group) : Patients with diabetes mellitus who have no evidence of diabetic nephropathy will be defined by a normal urinary albumin-to-creatinine ratio (UACR) and preserved renal function.
- Diabetic Nephropathy group (DN group) :
Patients with diabetes mellitus and diabetic nephropathy will be defined by the presence of elevated UACR and/or impaired renal function as assessed by estimated glomerular filtration rate (eGFR).
Subgroup Analysis :
Within the diabetic nephropathy group, further subgroup analyses will be performed to assess differences in NHHR according to:
Type of diabetes (Type 1 vs. Type 2 diabetes mellitus) Stages of chronic kidney disease (CKD) are classified based on KDIGO definitions of CKD based on estimated GFR and albuminuria.
Type of the study: Comparative cross-sectional study
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Mellitus without Diabetic Nephropathy (DM group) | – | –Patients with diabetes mellitus who have no evidence of diabetic nephropathy will be defined by a normal urinary albumin-to-creatinine ratio (UACR) and preserved renal function. |
| Diabetic Nephropathy group (DN group) | – | –Patients with diabetes mellitus and diabetic nephropathy will be defined by the presence of elevated UACR and/or impaired renal function as assessed by estimated glomerular filtration rate (eGFR). And within the diabetic nephropathy group, further subgroup analyses will be performed to assess differences in NHHR according to: 1. Type of diabetes (Type 1 vs. Type 2 diabetes mellitus) 2. Stages of chronic kidney disease (CKD) are classified based on KDIGO definitions of CKD based on estimated GFR and albuminuria. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with DM attending the internal medicine outpatient clinics and inpatient department.
Key inclusion criteria (3 listed)
- Adults aged ≥18 years
- Diagnosed cases of diabetes mellitus (Type 1 or Type 2), with or without diabetic nephropathy
- Willingness to participate and provide informed consent
Key exclusion criteria (5 listed)
- Known non-diabetic causes of chronic kidney disease
- Acute kidney injury
- Chronic inflammatory or autoimmune diseases
- Current use of medications known to significantly alter lipid metabolism (other than standard lipid-lowering therapy, if applicable)
- End-stage renal disease patients on dialysis
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
Association between the non-high-density lipoprotein cholesterol-to-high-density lipoprotein cholesterol ratio (NHHR) and the presence of diabetic nephropathy.
Time frame: At baseline
Diabetic nephropathy defined as urinary albumin-to-creatinine ratio (UACR) ≥30 mg/g and/or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m², measured at enrollment. The non-HDL cholesterol to HDL cholesterol ratio (NHHR) will be calculated from fasting lipid profile obtained at the same visit.
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 17 Mar 2026.
- Background: PubMed 39602386Zhang L, Fan D, Zhu T, Geng L, Gan L, Ou S, Yin D. The ratio of non-high-density lipoprotein cholesterol to high-density lipoprotein cholesterol is associated with diabetic kidney disease: A cross-sectional study. PLoS One. 2024 Nov 27;19(11):e0311620. doi: 10.1371/journal.pone.0311620. eCollection 2024.
- Background: PubMed 38773578Tan MY, Weng L, Yang ZH, Zhu SX, Wu S, Su JH. The association between non-high-density lipoprotein cholesterol to high-density lipoprotein cholesterol ratio with type 2 diabetes mellitus: recent findings from NHANES 2007-2018. Lipids Health Dis. 2024 May 21;23(1):151. doi: 10.1186/s12944-024-02143-8.
- Background: PubMed 39972003Su X, Rao H, Zhao C, Wu J, Zhang X, Li D. Association between the non-high-density lipoprotein cholesterol to high-density lipoprotein cholesterol ratio and mortality among hypertension patients. Sci Rep. 2025 Feb 19;15(1):6012. doi: 10.1038/s41598-025-88539-7.
- Background: PubMed 35784566Pan X, Lin X, Huang X, Xu J, Ye L, Zhang T, Hu S, Jiang H, Ren Y, Shan PF. The Burden of Diabetes-Related Chronic Kidney Disease in China From 1990 to 2019. Front Endocrinol (Lausanne). 2022 Jun 15;13:892860. doi: 10.3389/fendo.2022.892860. eCollection 2022.
- Background: PubMed 36046539Lokpo SY, Laryea R, Osei-Yeboah J, Owiredu WKBA, Ephraim RKD, Adejumo EN, Ametepe S, Appiah M, Peter N, Affrim P, Kwadzokpui PK, Abeka OK. The pattern of dyslipidaemia and factors associated with elevated levels of non-HDL-cholesterol among patients with type 2 diabetes mellitus in the Ho municipality: A cross sectional study. Heliyon. 2022 Aug 17;8(8):e10279. doi: 10.1016/j.heliyon.2022.e10279. eCollection 2022 Aug.
- Background: PubMed 35583863Liu C, Dhindsa D, Almuwaqqat Z, Ko YA, Mehta A, Alkhoder AA, Alras Z, Desai SR, Patel KJ, Hooda A, Wehbe M, Sperling LS, Sun YV, Quyyumi AA. Association Between High-Density Lipoprotein Cholesterol Levels and Adverse Cardiovascular Outcomes in High-risk Populations. JAMA Cardiol. 2022 Jul 1;7(7):672-680. doi: 10.1001/jamacardio.2022.0912.
- Background: PubMed 19414839Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.
- Background: PubMed 36507639ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 1. Improving Care and Promoting Health in Populations: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Supple 1):S10-S18. doi: 10.2337/dc23-S001.
- Background: PubMed 40218883Chen X, Liang M, Zhang J, Xu C, Chen L, Hu R, Zhong J. The Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) to HDL-C Ratio (NHHR) and Its Association with Chronic Kidney Disease in Chinese Adults with Type 2 Diabetes: A Preliminary Study. Nutrients. 2025 Mar 24;17(7):1125. doi: 10.3390/nu17071125.
- Background: PubMed 33189186Chan JCN, Lim LL, Wareham NJ, Shaw JE, Orchard TJ, Zhang P, Lau ESH, Eliasson B, Kong APS, Ezzati M, Aguilar-Salinas CA, McGill M, Levitt NS, Ning G, So WY, Adams J, Bracco P, Forouhi NG, Gregory GA, Guo J, Hua X, Klatman EL, Magliano DJ, Ng BP, Ogilvie D, Panter J, Pavkov M, Shao H, Unwin N, White M, Wou C, Ma RCW, Schmidt MI, Ramachandran A, Seino Y, Bennett PH, Oldenburg B, Gagliardino JJ, Luk AOY, Clarke PM, Ogle GD, Davies MJ, Holman RR, Gregg EW. The Lancet Commission on diabetes: using data to transform diabetes care and patient lives. Lancet. 2021 Dec 19;396(10267):2019-2082. doi: 10.1016/S0140-6736(20)32374-6. Epub 2020 Nov 12. No abstract available.
- Background: PubMed 35368036Achila OO, Fessahye N, Mengistu ST, Habtemikael NT, Werke WY, Zemichael FT, Leghese HN, Weldegegish TA, Tekeste TH, Garoy EY. A community based cross sectional study on the prevalence of dyslipidemias and 10 years cardiovascular risk scores in adults in Asmara, Eritrea. Sci Rep. 2022 Apr 2;12(1):5567. doi: 10.1038/s41598-022-09446-9.
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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.
Ahmed Mohamed Ashmawy, Professor principal investigator
Assiut University
Noha Gamal Abdel-Malek, Assistant lecturer principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathy and Dyslipidemia, 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 3 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 17 Mar 2026. 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?
Contact Ragaey Edward Riad (+20 1206503994, ragaeyedward@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between the non-high-density lipoprotein cholesterol-to-high-density lipoprotein cholesterol ratio (NHHR) and the presence of diabetic nephropathy. (time frame: At 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 NCT07476248, which also lists 11 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 17 Mar 2026.