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

NCT ID: NCT06591104

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-10-31

Brief Summary

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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

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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

Conditions

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Diabetic Kidney Disease Obesity Metabolic Syndrome Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

24 hour urinary protein

Intervention Type DIAGNOSTIC_TEST

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

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

24 hour urinary protein

Intervention Type DIAGNOSTIC_TEST

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

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

24 hour urinary protein

Intervention Type DIAGNOSTIC_TEST

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

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

24 hour urinary protein

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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24 hour urinary protein

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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kidney function test : urea and creatinine eGFR

Eligibility Criteria

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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 \&lt;18.5 kg/m2
4. co-existing non-diabetic renal disease
5. Pregnancy and patients with malignancy
6. Urinary tract infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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George Armia Ghaly Abdelmaseih

Resident physician at Internal Medicine department

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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George Armia Abdelmaseih, MBBCh

Role: CONTACT

01092790414

Salah Abdel-Azim Argoon, prof dr

Role: CONTACT

01019683366

References

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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.

Reference Type BACKGROUND
PMID: 24673339 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35385633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37234807 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29489920 (View on PubMed)

Other Identifiers

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obesity and DKD in T2DM

Identifier Type: -

Identifier Source: org_study_id

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