| CTRI Number |
CTRI/2019/08/020734 [Registered on: 16/08/2019] Trial Registered Prospectively |
| Last Modified On: |
16/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Relationship between Metabolic Syndrome and Chronic Kidney disease in South India |
|
Scientific Title of Study
|
Association between metabolic syndrome and Chronic Kidney disease: a study in South India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hannah Mathew |
| Designation |
Medical student |
| Affiliation |
KMC MANIPAL |
| Address |
Department of Pathology, Centre for Basic Sciences, KMC, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
8111920582 |
| Fax |
|
| Email |
h2mathew@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mary Mathew |
| Designation |
Professor |
| Affiliation |
KMC MANIPAL |
| Address |
Department of Pathology,
Centre for Basic Sciences, KMC, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9845678806 |
| Fax |
|
| Email |
marymathew883@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hannah Mathew |
| Designation |
Medical student |
| Affiliation |
KMC MANIPAL |
| Address |
Department of Pathology, Centre for Basic Sciences, KMC, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
8111920582 |
| Fax |
|
| Email |
h2mathew@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
ICMR HEADQUARTERS DETAIL. INDIAN COUNCIL OF MEDICAL RESEARCH , ANSARI NAGAR, NEW DELHI-110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Hannah Mathew |
Kasturba Medical College Hospital |
Nephrology OPD,
Nephrology department,
Kasturba Hospital,
Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
8111920582
h2mathew@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Physical and laboratory investigations |
Physical intervention includes measuring of waist girth and blood pressure.
Laboratory investigations such as Serum TG, Serum HDL, Fasting blood glucose(if needed) will be performed if not done in the recent past. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients diagnosed with CKD of both genders. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between Metabolic Syndrome and Chronic Kidney Disease. Number of CKD patients( out of sample size of 200) who also have metabolic syndrome will be noted, noting the stage of CKD and Metabolic syndrome, to associate the two. |
Kidney failure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| correlation of non-modifiable parameters such as age and BMI with modified NCEP- ATP III diagnostic criteria |
End Stage Renal Disease |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "194"
Final Enrollment numbers achieved (India)="194" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/08/2019 |
| Date of Study Completion (India) |
10/08/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/08/2019 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The prevalence of Metabolic Syndrome in this
study population was high compared to the estimated prevalence in the general
Indian population. However, there was no significant correlation between CKD
and the various parameters of MetS. A significant association was found between
increasing age and BMI with Metabolic Syndrome and between cardiovascular
events and MetS with CKD. In view of the high incidence in the Indian
population screening and counselling on a large scale would be beneficial and
more studies are required bridge the gaps in the knowledge of MetS and chronic
kidney disease.
|