| 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
|
|
|
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
|
|
|
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 |