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
• Interventions: Diagnostic Test: 24 hour urinary protein

• 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

Arm && Interventions

Group	Intervention	Description
metabolically healthy non obesity (MHNO)	24 hour urinary protein	According to the NCEP ATP III definition, metabolic syndrome is present if three or more of the following five criteria are met: waist circumference over 40 inches (men) or 35 inches (women), blood pressure over 130/85 mmHg, fasting triglyceride (TG) level over 150 mg/dl, fasting high-density lipoprotein (HDL) cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women) and fasting blood sugar over 100 mg/dl. Obesity was defined as a BMI of ≥ 25.0 kg/m2 . Patients with a BMI of 18.5-\<23.0 were considered normal weight; for those with a BMI of 23.0-\<25.0 were overweight. The patients with normal weight and those who were overweight were collapsed into the non-obesity group. so this group of patients are metabolically healthy and non obese with BMI 18.5 - \<25
metabolically healthy obesity ( MHO )	24 hour urinary protein	According to the NCEP ATP III definition, metabolic syndrome is present if three or more of the following five criteria are met: waist circumference over 40 inches (men) or 35 inches (women), blood pressure over 130/85 mmHg, fasting triglyceride (TG) level over 150 mg/dl, fasting high-density lipoprotein (HDL) cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women) and fasting blood sugar over 100 mg/dl. Obesity was defined as a BMI of ≥ 25.0 kg/m2 . Patients with a BMI of 18.5-\<23.0 were considered normal weight; for those with a BMI of 23.0-\<25.0 were overweight. The patients with normal weight and those who were overweight were collapsed into the non-obesity group. so this group of patients are metabolically healthy but they are obese with BMI of ≥ 25.0 kg/m2
metabolically unhealthy non obsesity ( MUNO )	24 hour urinary protein	According to the NCEP ATP III definition, metabolic syndrome is present if three or more of the following five criteria are met: waist circumference over 40 inches (men) or 35 inches (women), blood pressure over 130/85 mmHg, fasting triglyceride (TG) level over 150 mg/dl, fasting high-density lipoprotein (HDL) cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women) and fasting blood sugar over 100 mg/dl. Obesity was defined as a BMI of ≥ 25.0 kg/m2 . Patients with a BMI of 18.5-\<23.0 were considered normal weight; for those with a BMI of 23.0-\<25.0 were overweight. The patients with normal weight and those who were overweight were collapsed into the non-obesity group. so this group of patients are metabolically unhealthy ( have three or more of metabolic syndrome criteria) and non obese with BMI 18.5 - \<25
metabolically unhealthy obesity ( MUO )	24 hour urinary protein	According to the NCEP ATP III definition, metabolic syndrome is present if three or more of the following five criteria are met: waist circumference over 40 inches (men) or 35 inches (women), blood pressure over 130/85 mmHg, fasting triglyceride (TG) level over 150 mg/dl, fasting high-density lipoprotein (HDL) cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women) and fasting blood sugar over 100 mg/dl. Obesity was defined as a BMI of ≥ 25.0 kg/m2 . Patients with a BMI of 18.5-\<23.0 were considered normal weight; for those with a BMI of 23.0-\<25.0 were overweight. The patients with normal weight and those who were overweight were collapsed into the non-obesity group. so this group of patients are metabolically unhealthy but they are obese with BMI of ≥ 25.0 kg/m2

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