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
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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NOT_YET_RECRUITING
71 participants
OBSERVATIONAL
2024-10-31
2025-10-31
Brief Summary
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2. Relation between DKD , obesity (BMI) and metabolic risk factors in patients with type 2 DM
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Detailed Description
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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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Study Design
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OTHER
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
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
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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George Armia Ghaly Abdelmaseih
Resident physician at Internal Medicine department
Central Contacts
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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.
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.
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.
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.
Other Identifiers
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obesity and DKD in T2DM
Identifier Type: -
Identifier Source: org_study_id
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