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

Not yet recruiting

• Conditions: Diabetic Kidney Disease; Obesity; Metabolic Syndrome; Diabetes Mellitus, Type 2

• Registration Number: NCT06591104
• Lead Sponsor: Assiut University

Brief Summary

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

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-09
• Study First Submitted QC: 2024-09-07
• Last Update Submitted: 2024-09-07
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11
• Study Start: 2024-10
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 71

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

1. Age less than 18
2. type 1 diabetes
3. those with a BMI <18.5 kg/m2
4. co-existing non-diabetic renal disease
5. Pregnancy and patients with malignancy
6. Urinary tract infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Conclusion of the relationship between metabolic phenotypes of obesity and Diabetic kidney disease in type 2 diabetes Mellitus patients	Baseline	conclusion the relation between metabolic phenotypes of obesity and diabetic kidney disease in type 2 diabetes mellitus patients