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Not yet recruiting NCT06591104

Metabolic Phenotypes of Obesity and Diabetic Kidney Disease in Patients with Type 2 Diabetes Mellitus

Observational Diabetic Kidney Disease Obesity Metabolic Syndrome Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 24 hour urinary protein.
Who it may be relevant to
Registry conditions: Diabetic Kidney Disease, Obesity, Metabolic Syndrome, Diabetes Mellitus, Type 2. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

1. Comparison between the 4 groups of metabolic phenotypes of obesity as regard the presence and frequency of DKD 2. Relation between DKD , obesity (BMI) and metabolic risk factors in patients with type 2 DM

Detailed description

Diabetes is the major cause of chronic kidney disease in industrialized countries. Individuals with diabetes and CKD are at a higher risk of developing End Stage Renal Disease and experiencing cardiovascular death. Type 2 DM complications are predicted by low estimated glomerular filtration rate and high urine albumin excretion(1).

Diabetic kidney disease is the primary cause of kidney failure globally, affecting 25% to 40% of persons with diabetes mellitus . Early diagnosis of high-risk patients is crucial due to the high-risk of progressive deterioration of kidney function leading to end-stage kidney disease, which ultimately requires kidney replacement therapy (2).

DKD risk factors include non modifiable factors like age , gender , race , genetics and modifiable factors like obesity and lifestyle. Obesity is typically associated with metabolic diseases such as hyperglycemia, dyslipidemia, and high blood pressure. Obesity's impact on renal insufficiency is debated ,and may be influenced by other metabolic abnormalities(3).

Metabolic phenotypes of obesity based on the BMI-based categories (non-obesity, obesity) and metabolic status (metabolically healthy status or metabolically unhealthy status): metabolically Healthy non-obesity (MHNO), metabolically healthy obesity (MHO), metabolically unhealthy non-obesity (MUNO) and metabolically unhealthy obesity (MUO)(3).

There is a strong correlation between obesity and the onset and course of chronic kidney disease, according to a number of population-based studies. the investigators think there are still unsolved issues about the connection between obesity and CKD(4).

so the study is concerned about detection of the relation between metabolic phenotypes of obesity and Diabetic kidney disease

Interventions

  • Diagnostic test 24 hour urinary protein
    proteinuria and renal function impairment will be detected in patients of four groups

Primary outcome measures

  • Conclusion of the relationship between metabolic phenotypes of obesity and Diabetic kidney disease in type 2 diabetes Mellitus patients [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Type 2 diabetic adult patients admitted at Assiut university hospital divided into 4 groups of metabolic phenotypes according to obesity and metabolic status .

Exclusion criteria

  • Age less than 18
  • type 1 diabetes
  • those with a BMI \<18.5 kg/m2
  • co-existing non-diabetic renal disease
  • Pregnancy and patients with malignancy
  • Urinary tract infection

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Bentata Y, Latrech H, Abouqal R. Does body mass index influence the decline of glomerular filtration rate in diabetic type 2 patients with diabetic nephropathy in a developing country? Ren Fail. 2014 Jul;36(6):838-46. doi: 10.3109/0886022X.2014.899472. Epub 2014 Mar 27. PMID 24673339
  • Jung CY, Yoo TH. Pathophysiologic Mechanisms and Potential Biomarkers in Diabetic Kidney Disease. Diabetes Metab J. 2022 Mar;46(2):181-197. doi: 10.4093/dmj.2021.0329. Epub 2022 Mar 24. PMID 35385633
  • Zhao L, Zou Y, Wu Y, Cai L, Zhao Y, Wang Y, Xiao X, Yang Q, Yang J, Ren H, Tong N, Liu F. Metabolic phenotypes and risk of end-stage kidney disease in patients with type 2 diabetes. Front Endocrinol (Lausanne). 2023 May 10;14:1103251. doi: 10.3389/fendo.2023.1103251. eCollection 2023. PMID 37234807
  • Evangelista LS, Cho WK, Kim Y. Obesity and chronic kidney disease: A population-based study among South Koreans. PLoS One. 2018 Feb 28;13(2):e0193559. doi: 10.1371/journal.pone.0193559. eCollection 2018. PMID 29489920

Identifiers

NCT: NCT06591104 · obesity and DKD in T2DM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗