| CTRI Number |
CTRI/2018/12/016699 [Registered on: 18/12/2018] Trial Registered Prospectively |
| Last Modified On: |
12/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Sarcopenia in Liver Cirrhosis – A cross-sectional study |
|
Scientific Title of Study
|
Prevalence and factors associated with Sarcopenia in Liver Cirrhosis – A cross-sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neil Palkhiwala |
| Designation |
DM Registrar Department of Gastroenterology and Hepatology |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Gastroenterology and Hepatology
Kasturba Hospital
Kasturba Medical College Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9099941005 |
| Fax |
|
| Email |
npalkhiwala7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Pai C |
| Designation |
Professor and HOD, Department of Gastroenterology and Hepatology |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Gastroenterology and Hepatology
Kasturba Hospital
Kasturba Medical College Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945376424 |
| Fax |
|
| Email |
cg.pai@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Neil Palkhiwala |
| Designation |
DM Registrar Department of Gastroenterology and Hepatology |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Gastroenterology and Hepatology
Kasturba Hospital
Kasturba Medical College Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9099941005 |
| Fax |
|
| Email |
npalkhiwala7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education (MAHE) university
Manipal
Udupi
Karnataka |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Manipal Academy of Higher Education
Manipal
Udupi 576104
Karnataka |
| 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 |
| Neil Palkhiwala |
Kasturba Hospital |
4th floor, OPD block
Department Gastroeneterology & Hepatology
Kasturba Medical College
Manipal
Udupi
Udupi
KARNATAKA |
9099941005
npalkhiwala7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with biochemical, radiologic or histopathologic evidence (wherever available) of liver cirrhosis |
|
| ExclusionCriteria |
| Details |
Patients with other conditions that can cause muscle wasting like chronic renal failure, malignancy, chronic inflammatory / infectious diseases [HIV, TB, HCC, chronic pancreatitis and with long standing Diabetes Mellitus [ >10 years]
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of Sarcopenia in Liver cirrhosis in this subgroup of patients
Assessment of reliable factors associated with development of Sarcopenia in Liver cirrhosis
|
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of Sarcopenia with consequences and complications of liver cirrhosis and portal hypertension, also with CTP and MELD-Na scores |
6 months |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
20/12/2018 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Sarcopenia is defined as poor muscle health, in terms of mass as well as function. It is one of the common complications of liver cirrhosis however frequently goes
unrecognized, despite it negatively impacting survival, quality of life, and
prognosis post liver transplant. There is
evidence to show that skeletal muscle abnormalities are related to poor outcome
in cirrhosis as well as after liver transplantation. Several established
prognostic models of cirrhosis such as Child–Pugh and MELD scores do not
include objective nutritional assessment. There have been no studies measuring
the prevalence of Sarcopenia in coastal Karnataka, and hence this study aims to
ascertain the prevalence and also to test for predictors of Sarcopenia, so as
to guide future studies involving intervention in the form nutritional build-up
before undergoing liver transplantation. |