Diabetic NephropathiesNCT06563791
Assessment of the Association Between Visceral Obesity and the Progression of Diabetic Nephropathy
An observational study of Diabetic Nephropathies, run by Assiut University.
Trial summary
Assessment of the association between visceral obesity and the progression of diabetic nephropathy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Nephropathies
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Oct 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic patients either type 1 or type 2 diabetes aged > 18 years whether known to have diabetic nephropathy or not with BMI is ≥ 25 kg/m2
Who may be able to join
- 1. Diabetic patients either type 1 or type 2 diabetes aged > 18 years whether known to have diabetic nephropathy or not.
- 2. BMI is ≥ 25 kg/m2
Who cannot join
- 1. Patients age < 18 years. 2. BMI < 25 kg/m2 3. Nondiabetic patients 4. Patients with non-diabetic kidney disease. 5. Patients with AKI 6. Patients with CKD stage 5 either on dialysis or not.
Trial locations and contacts
No sites are listed yet.
Radwa awad contact
About this study
Assessment of the association between visceral obesity and the progression of diabetic nephropathy
Read the detailed description
Type 2 diabetes mellitus is a disorder of diverse aetiology characterised by hyperglycemia resulting from abnormalities of insulin action, insulin production, or both, and the global population with diabetes mellitus is expected to be around 439 million by 2030 . Diabetic nephropathy is the most prevalent microvascular consequence of DM. It develops in around 40% of DM patients.
Obesity, which has now reached pandemic ratios, is frequently accompanied by diabetes mellitus type 2 because they share common pathophysiological pathways . Abdominal obesity is found to be a negligent form of obesity with dangerous consequences. It has been identified as potentially hazardous factor for diabetic complications. Several abdominal obesity measures have been developed including the visceral adiposity index (VAI) , lipid accumulation product (LAP) , neck circumference (NC), waist-to-hip ratio (WHR) Lipid accumulation product (LAP) and visceral adiposity index (VAI) are new, non-imaging indicators of visceral adiposity measured using body mass index (BMI), waist circumference (WC), and serum lipid profile. It was predicted in some studies that LAP and VAI have a stronger association with poor renal outcomes than BMI and WC.
- Conditions
- Diabetic Nephropathies
- Medical subject headings
- Diabetic Nephropathies
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the association between visceral obesity and the progression of diabetic nephropathy
Assessment of visceral obesity new measures as (the visceral adiposity index (VAI) , lipid accumulation product (LAP) , neck circumference (NC), waist-to-hip ratio (WHR) ) as a risk factor for the progression of diabetic nephropathy and poor renal outcome.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathiesStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Mohamed Ehab Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563791
- Sponsor's protocol ID
- Visceral obesity and DN
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thipsawat S. Early detection of diabetic nephropathy in patient with type 2 diabetes mellitus: A review of the literature. Diab Vasc Dis Res. 2021 Nov-Dec;18(6):14791641211058856. doi: 10.1177/14791641211058856.
PubMed 34791910Boutari C, DeMarsilis A, Mantzoros CS. Obesity and diabetes. Diabetes Res Clin Pract. 2023 Aug;202:110773. doi: 10.1016/j.diabres.2023.110773. Epub 2023 Jun 23.
PubMed 37356727Wan H, Wang Y, Xiang Q, Fang S, Chen Y, Chen C, Zhang W, Zhang H, Xia F, Wang N, Lu Y. Associations between abdominal obesity indices and diabetic complications: Chinese visceral adiposity index and neck circumference. Cardiovasc Diabetol. 2020 Jul 31;19(1):118. doi: 10.1186/s12933-020-01095-4.
PubMed 32736628Bullen AL, Katz R, Kumar U, Gutierrez OM, Sarnak MJ, Kramer HJ, Shlipak MG, Ix JH, Judd SE, Cushman M, Garimella PS. Lipid accumulation product, visceral adiposity index and risk of chronic kidney disease. BMC Nephrol. 2022 Dec 15;23(1):401. doi: 10.1186/s12882-022-03026-9.
PubMed 36522626
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Association Between Visceral Obesity and the Progression of Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT06563791
- Acronym / sponsor ID
- Visceral obesity and DN
- Conditions
- Diabetic Nephropathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 21 Aug 2024 (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.
Assessment of the association between visceral obesity and the progression of diabetic nephropathy
Detailed description
Type 2 diabetes mellitus is a disorder of diverse aetiology characterised by hyperglycemia resulting from abnormalities of insulin action, insulin production, or both, and the global population with diabetes mellitus is expected to be around 439 million by 2030 . Diabetic nephropathy is the most prevalent microvascular consequence of DM. It develops in around 40% of DM patients.
Obesity, which has now reached pandemic ratios, is frequently accompanied by diabetes mellitus type 2 because they share common pathophysiological pathways . Abdominal obesity is found to be a negligent form of obesity with dangerous consequences. It has been identified as potentially hazardous factor for diabetic complications. Several abdominal obesity measures have been developed including the visceral adiposity index (VAI) , lipid accumulation product (LAP) , neck circumference (NC), waist-to-hip ratio (WHR) Lipid accumulation product (LAP) and visceral adiposity index (VAI) are new, non-imaging indicators of visceral adiposity measured using body mass index (BMI), waist circumference (WC), and serum lipid profile. It was predicted in some studies that LAP and VAI have a stronger association with poor renal outcomes than BMI and WC.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients either type 1 or type 2 diabetes aged > 18 years whether known to have diabetic nephropathy or not with BMI is ≥ 25 kg/m2
Key inclusion criteria (2 listed)
- 1. Diabetic patients either type 1 or type 2 diabetes aged > 18 years whether known to have diabetic nephropathy or not.
- 2. BMI is ≥ 25 kg/m2
Key exclusion criteria (1 listed)
- 1. Patients age < 18 years. 2. BMI < 25 kg/m2 3. Nondiabetic patients 4. Patients with non-diabetic kidney disease. 5. Patients with AKI 6. Patients with CKD stage 5 either on dialysis or not.
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
Assessment of the association between visceral obesity and the progression of diabetic nephropathy
Time frame: Baseline
Assessment of visceral obesity new measures as (the visceral adiposity index (VAI) , lipid accumulation product (LAP) , neck circumference (NC), waist-to-hip ratio (WHR) ) as a risk factor for the progression of diabetic nephropathy and poor renal outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Results publication: PubMed 34791910Thipsawat S. Early detection of diabetic nephropathy in patient with type 2 diabetes mellitus: A review of the literature. Diab Vasc Dis Res. 2021 Nov-Dec;18(6):14791641211058856. doi: 10.1177/14791641211058856.
- Results publication: PubMed 37356727Boutari C, DeMarsilis A, Mantzoros CS. Obesity and diabetes. Diabetes Res Clin Pract. 2023 Aug;202:110773. doi: 10.1016/j.diabres.2023.110773. Epub 2023 Jun 23.
- Results publication: PubMed 32736628Wan H, Wang Y, Xiang Q, Fang S, Chen Y, Chen C, Zhang W, Zhang H, Xia F, Wang N, Lu Y. Associations between abdominal obesity indices and diabetic complications: Chinese visceral adiposity index and neck circumference. Cardiovasc Diabetol. 2020 Jul 31;19(1):118. doi: 10.1186/s12933-020-01095-4.
- Results publication: PubMed 36522626Bullen AL, Katz R, Kumar U, Gutierrez OM, Sarnak MJ, Kramer HJ, Shlipak MG, Ix JH, Judd SE, Cushman M, Garimella PS. Lipid accumulation product, visceral adiposity index and risk of chronic kidney disease. BMC Nephrol. 2022 Dec 15;23(1):401. doi: 10.1186/s12882-022-03026-9.
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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. This study is not recruiting at the moment.
Radwa awad contact
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathies, 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 2 inclusion and 1 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 21 Aug 2024. 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 Nourhan Mohamed Ehab (+201062839349, mohamedehabahmed204@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the association between visceral obesity and the progression of diabetic nephropathy (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 NCT06563791, which also lists 4 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 21 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.