Diabetic Kidney DiseaseNCT06591104
Metabolic Phenotypes of Obesity and Diabetic Kidney Disease in Patients with Type 2 Diabetes Mellitus
An observational study of Diabetic Kidney Disease and Obesity, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Kidney Disease, Obesity, Metabolic Syndrome
- What is being tested?
- 24 hour urinary protein
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetic adult patients admitted at Assiut university hospital
Who may be able to join
- Type 2 diabetic adult patients admitted at Assiut university hospital divided into 4 groups of metabolic phenotypes according to obesity and metabolic status .
Who cannot join
- Age less than 18
- type 1 diabetes
- those with a BMI \<18.5 kg/m2
- co-existing non-diabetic renal disease
- Pregnancy and patients with malignancy
- Urinary tract infection
Trial locations and contacts
No sites are listed yet.
About this study
- Comparison between the 4 groups of metabolic phenotypes of obesity as regard the presence and frequency of DKD
- Relation between DKD , obesity (BMI) and metabolic risk factors in patients with type 2 DM
Read the 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
- Being tested
- 24 hour urinary protein
- Medical subject headings
- Diabetic Nephropathies, Obesity, Metabolic Syndrome, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 hour urinary proteinDiagnostic test
Also called kidney function test : urea and creatinine, eGFR
proteinuria and renal function impairment will be detected in patients of four groups
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: 24 hour urinary protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Armia Ghaly Abdelmaseih, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591104
- Sponsor's protocol ID
- obesity and DKD in T2DM
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24673339Jung 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.
PubMed 35385633Zhao 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.
PubMed 37234807Evangelista 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.
PubMed 29489920
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Phenotypes of Obesity and Diabetic Kidney Disease in Patients with Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06591104
- Acronym / sponsor ID
- obesity and DKD in T2DM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Comparison between the 4 groups of metabolic phenotypes of obesity as regard the presence and frequency of DKD
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| metabolically healthy non obesity (MHNO) | – | Diagnostic Test: 24 hour urinary proteinAccording 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 ) | – | Diagnostic Test: 24 hour urinary proteinAccording 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 ) | – | Diagnostic Test: 24 hour urinary proteinAccording 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 ) | – | Diagnostic Test: 24 hour urinary proteinAccording 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetic adult patients admitted at Assiut university hospital
Key inclusion criteria (1 listed)
- Type 2 diabetic adult patients admitted at Assiut university hospital divided into 4 groups of metabolic phenotypes according to obesity and metabolic status .
Key exclusion criteria (6 listed)
- Age less than 18
- type 1 diabetes
- those with a BMI \<18.5 kg/m2
- co-existing non-diabetic renal disease
- Pregnancy and patients with malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24 hour urinary proteinAlso: kidney function test : urea and creatinine, eGFRproteinuria and renal function impairment will be detected in patients of four groups | Diagnostic test | metabolically healthy non obesity (MHNO), metabolically healthy obesity ( MHO ), metabolically unhealthy non obsesity ( MUNO ), metabolically unhealthy obesity ( MUO ) |
Primary outcome
Conclusion of the relationship between metabolic phenotypes of obesity and Diabetic kidney disease in type 2 diabetes Mellitus patients
Time frame: Baseline
conclusion the relation between metabolic phenotypes of obesity and diabetic kidney disease in type 2 diabetes mellitus patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 24673339Bentata 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.
- Background: PubMed 35385633Jung 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.
- Background: PubMed 37234807Zhao 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.
- Background: PubMed 29489920Evangelista 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Kidney Disease and Obesity, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George Armia Abdelmaseih, MBBCh (01092790414, georgearmia12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conclusion of the relationship between metabolic phenotypes of obesity and Diabetic kidney disease in type 2 diabetes Mellitus patients (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06591104, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.