| CTRI Number |
CTRI/2014/07/004725 [Registered on: 10/07/2014] Trial Registered Retrospectively |
| Last Modified On: |
17/11/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Distribution and treatment of non alcoholic fatty liver disease in Indian people with diabetes and obesity related conditions |
|
Scientific Title of Study
|
The Epidemiology and Treatment of Non-Alcoholic Fatty Liver Disease In Indian Population with Diabetes And Metabolic Syndrome. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Kumar Sahay |
| Designation |
Professor of Endocrinology |
| Affiliation |
Osmania Medical College and Osmania General Hospital |
| Address |
Osmania General Hospital
Afzalgunj Hyderabad Andhra Pradesh
Hyderabad
ANDHRA PRADESH
500012
India |
| Phone |
|
| Fax |
|
| Email |
sahayrk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohammed Alim |
| Designation |
Research Fellow |
| Affiliation |
Osmania Medical College and Hospital |
| Address |
George Institute for Global Health.#839 C Rd No 44A, Hyderabad.
Hyderabad
ANDHRA PRADESH
500033
India |
| Phone |
|
| Fax |
|
| Email |
mohdalim786@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Kumar Sahay |
| Designation |
Professor of Endocrinology |
| Affiliation |
Osmania Medical College and Osmania General Hospital |
| Address |
Osmania General Hospital
Afzalgunj Hyderabad Andhra Pradesh
Hyderabad
ANDHRA PRADESH
500012
India |
| Phone |
|
| Fax |
|
| Email |
sahayrk@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Osmania General Hospital |
| Address |
Afzalgunj Hyderabad |
| Type of Sponsor |
Government 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 |
| Dr Rakesh Kumar Sahay |
Osmania General Hospital |
Department of Endocrinology, 2nd Floor, Golden Jubilee Block and Department of Gastroenterology. Afzalgunj Hyderabad Andhra Pradesh
Hyderabad
ANDHRA PRADESH |
9849597507
sahayrk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Scientific Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Non Alcoholic Fatty Liver Disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with Type II Diabetes Mellitus and Metabolic Syndrome
a. Fasting Blood Sugar >120 mg/dL
b. Metabolic Syndrome diagnosed as per NCEP- ATP III criteria.
2. Patients with age ≥18 years.
3. Patient with stable dose of diabetic medication for last three months.
4. Alcohol intake of < 21 units/week for men and < 14 units/week for women.
|
|
| ExclusionCriteria |
| Details |
1. Patient taking Thiazolidinedione’s
2. Patients with cirrhosis.
3. Patients with NYHA class III-IV.
4. Patients having neurological disease.
5. Patient with uncontrolled blood pressure( 3 antihypertensive medication)
6. Patients on Drugs known to induce fatty liver such as methotrexate, estrogens, tamoxifen and amiodarone.
7. Unable to be followed for the duration of the clinical trial
8. Inability to obtain informed consent
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
a)To assess the prevalence and incidence of Non-Alcoholic Fatly Liver Disease (NAFLD) in patients with Diabetes and Metabolic Syndrome.
b) Anthropometric measures. |
From enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| AST aspartate aminotransferase at the end of three months of treatment. |
from enrollment to 3 months |
| ALT alanine aminotransferase at the end of three months of treatment. |
From enrollment to 3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
26/05/2014 |
| 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) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an observational study that will determine the prevalence and incidence of Non Alcoholic Fatty Liver Disease (NAFLD) in Patients with Diabetes and Metabolic syndrome.This study will also follow up with patients receiving treatment for NAFLD as per current guidelines and standard of care. |