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NCT Number: NCT06591104

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

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

24 hour urinary protein

Diagnostic Test

proteinuria and renal function impairment will be detected in patients of four groups

Other names: kidney function test : urea and creatinine, eGFR

Primary outcomes

  1. Conclusion of the relationship between metabolic phenotypes of obesity and Diabetic kidney disease in type 2 diabetes Mellitus patients

    Time frame: Baseline

    conclusion the relation between metabolic phenotypes of obesity and diabetic kidney disease in type 2 diabetes mellitus patients

Study contacts

Contact information is provided by the study sponsor or research team.

George Armia Abdelmaseih, MBBCh

CONTACT

[email protected]

01092790414

Salah Abdel-Azim Argoon, prof dr

CONTACT

[email protected]

01019683366

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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