NCT06563791

Brief Summary

Assessment of the association between visceral obesity and the progression of diabetic nephropathy

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

August 6, 2024

Last Update Submit

August 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • \- 1. Diabetic patients either type 1 or type 2 diabetes aged \> 18 years whether known to have diabetic nephropathy or not.
  • \. BMI is ≥ 25 kg/m2

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

  • Boutari 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.

  • Wan 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.

  • Bullen 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.

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Central Study Contacts

Radwa awad

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 6, 2024

First Posted

August 21, 2024

Study Start

September 1, 2024

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

August 21, 2024

Record last verified: 2024-08