- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07922694
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity-Related Indices in Association With Albuminuria Level in Patients With Type 2 Diabetes Mellitus
This cross-sectional study aims to evaluate obesity-related indices and albuminuria levels in patients with type 2 diabetes mellitus.
Study Overview
Status
Conditions
Detailed Description
Type 2 diabetes mellitus is a leading cause of chronic kidney disease. Obesity-related indices such as body mass index, waist-to-height ratio, body roundness index, visceral adiposity index, and triglyceride-glucose index are simple measures of body composition and metabolic status.
This observational study will calculate multiple obesity-related indices and measure urine albumin-to-creatinine ratio in adult patients with type 2 diabetes mellitus.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mahmoud M Sadek, Resident
- Phone Number: 01550428880
- Email: Mahmud.18313212@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Adult patients aged 18 years or older with established type 2 diabetes mellitus attending Assiut University Hospitals.
Description
Inclusion Criteria:
- - Age 18 years or older
- Established diagnosis of type 2 diabetes mellitus
- Ability to provide written informed consent
Exclusion Criteria:
- - Type 1 diabetes mellitus
- Pregnancy
- Acute kidney injury
- Known primary glomerular disease
- Active urinary tract infection
- Decompensated liver disease or active malignancy
- Advanced chronic kidney disease (eGFR <60 mL/min/1.73m²)
- Conditions preventing reliable anthropometric assessment
Study Plan
How is the study designed?
Design Details
- Observational Models: CASE_ONLY
- Time Perspectives: CROSS_SECTIONAL
Cohorts and Interventions
Group / Cohort |
|---|
|
Patients with Type 2 Diabetes Mellitus
Adult patients with established type 2 diabetes mellitus who will undergo anthropometric measurements and laboratory assessment of albuminuria. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urine albumin-to-creatinine ratio
Time Frame: Baseline
|
Mean urine albumin-to-creatinine ratio in milligrams per gram. |
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimated glomerular filtration rate
Time Frame: Baseline
|
Mean estimated glomerular filtration rate calculated by the CKD-EPI 2021 equation in milliliters per minute per 1.73 square meters. |
Baseline
|
|
Body mass index
Time Frame: Baseline
|
Mean body mass index calculated as weight in kilograms divided by height in meters squared. |
Baseline
|
|
Waist-to-height ratio
Time Frame: Baseline
|
Mean waist-to-height ratio calculated as waist circumference divided by height. |
Baseline
|
|
Body roundness index
Time Frame: Baseline
|
Mean body roundness index calculated from waist circumference and height. |
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Manal E EzzEl-dine Abdel-Mooty, prof, Internal Medicine Department, Assiut University Hospitals
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Endocrine System Diseases
- Nutrition Disorders
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Metabolic Diseases
- Overnutrition
- Body Weight
- Urination Disorders
- Urological Manifestations
- Glucose Metabolism Disorders
- Overweight
- Proteinuria
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Diabetes Mellitus, Type 2
- Diabetes Mellitus
- Albuminuria
Other Study ID Numbers
- Obesity-Indices-T2DM-Assiut
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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