Clinical trial NCT06563791: Assessment of the Association Between Visceral Obesity and the Progression of Diabetic Nephropathy
Official title: Assessment of the Association Between Visceral Obesity and the Progression of Diabetic Nephropathy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetic Nephropathies
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Assessment of the association between visceral obesity and the progression of diabetic nephropathy
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.