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

NCT06591104 | Not Yet Recruiting

• 1 other identifier: obesity and DKD in T2DM
• Study Type: observational
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline

Study Arms (4)

metabolically healthy non obesity (MHNO)

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

Diagnostic Test: 24 hour urinary protein

metabolically healthy obesity ( MHO )

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

Diagnostic Test: 24 hour urinary protein

metabolically unhealthy non obsesity ( MUNO )

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

Diagnostic Test: 24 hour urinary protein

metabolically unhealthy obesity ( MUO )

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

Diagnostic Test: 24 hour urinary protein

Interventions

24 hour urinary protein DIAGNOSTIC_TEST

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

Also known as: kidney function test : urea and creatinine, eGFR

metabolically healthy non obesity (MHNO); metabolically healthy obesity ( MHO ); metabolically unhealthy non obsesity ( MUNO ); metabolically unhealthy obesity ( MUO )

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetic adult patients admitted at Assiut university hospital

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Diabetic Nephropathies; Obesity; Metabolic Syndrome; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Central Study Contacts

George Armia Abdelmaseih, MBBCh

CONTACT

01092790414; georgearmia12@gmail.com

Salah Abdel-Azim Argoon, prof dr

CONTACT

01019683366; argoons@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician at Internal Medicine department

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share