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CTRI Number  CTRI/2024/06/069362 [Registered on: 21/06/2024] Trial Registered Prospectively
Last Modified On: 11/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Role of microalbuminuria and creatinine in fatty and non-fatty person 
Scientific Title of Study   Role of microalbuminuria and creatinine in the obese and non-obese subject 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saurabh Anil Vighe 
Designation  Post Graduate Medical Laboratory Technology 
Affiliation  Jawaharlal Nehru Medical College Sawangi  
Address  Department of Pathology Jawaharlal Nehru Medical College DMIHER Sawangi Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  8767084017  
Fax    
Email  saurabhvighe2001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrAnjali V Manglaram Vagga 
Designation  Associate professor Department of Biochemistry 
Affiliation  Jawaharlal Nehru Medical College Sawangi  
Address  Department of Pathology Jawaharlal Nehru Medical College DMIHER Sawangi Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9970001431  
Fax    
Email  anjali.biochemistry@dmiher.edu.in  
 
Details of Contact Person
Public Query
 
Name  DrAnjali V Manglaram Vagga 
Designation  Associate professor Department of Biochemistry 
Affiliation  Jawaharlal Nehru Medical College Sawangi  
Address  Department of Pathology Jawaharlal Nehru Medical College DMIHER Sawangi Wardha


MAHARASHTRA
442001
India 
Phone  9970001431  
Fax    
Email  anjali.biochemistry@dmiher.edu.in  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Datta Meghe Institute of Higher Education and Research Sawangi Wardha 442001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Saurabh Anil Vighe  Datta Meghe Institute of Higher Education and Research  Dept of Biochemistry, Ground Floor, JNMC building Sawangi
Wardha
MAHARASHTRA 
8767084017

saurabhvighe2001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Datta Meghe Institute of Higher Education and Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N08||Glomerular disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NA 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.This research will includes total 78 patients. 2.Subjects of both sexes will be include.
3.All patients, regardless of age or gender.
4.Who present with symptoms of microalbuminuria and creatinine will be included.
5.The waist circumference of the young, obese patients—90 cm for men and 82 cm for women was used to determine their selection.
 
 
ExclusionCriteria 
Details  1.History and /or laboratory data suggestive of Chronic kidney diseases.
2. Patients will be excluded if they are symptoms of urinary tract infection (UTI).
3.Patient will be exclude if presence of leucocytes, nitrites, and blood found in urine. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
All early renal failure patients expected to have their microalbuminuria levels checked, and these levels expected to be significantly greater in early renal failure patients.  assessment will be done at the end of 12 month 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NA 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction : : Microalbuminuria refers to an elevated excretion rate of albumin in the urine, ranging from 30 to 299 mg/g creatinine in measurement. It raises the chances of heart disease and death and shows issues with how the blood vessels function. Serum creatinine is a commonly studied substance in clinical chemistry labs worldwide. Assessing kidney function is aided by the creatinine test, while obesity raises the likelihood of developing CKD. Need of the study :  To enhance patient care and results, it is crucial to examine the levels of microalbuminuria and creatinine in obese and non-obese patients. These researches can provide significant understanding of kidney health, metabolic function, and cardiovascular risk.

Aim: To study the role of microalbuminuria and creatinine in obese and non-obese subjects. Material and method : This protocol for study will be conducted in the Central Clinical Laboratory at the Biochemistry division of Department of Biochemistry of Acharya Vinoba Bhave Rural Hospital associated with Jawaharlal Nehru medical college situated in the state of Maharashtra,in india from November 2023 to October 2024. Patient between the age group of 10 years to 80 years will be taken. Total 78 patient will be taken ,39 will be a obese population and 39 will be a non-obese. 18 patients of microalbuminuria will be taken as cases and 17 creatinine were taken as controls. Before and throughout the trial, all ethical procedures were followed and written agreement was obtained. Patients with kidney disease bought to be considered for the trial. All Patients regardless of age or gender, who present with symptoms of microalbuminuria and creatinine will be included. The waist circumference of the young, obese patients—90 cm for men and 82 cm for women was used to determine their selection

 
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