| CTRI Number |
CTRI/2023/06/054199 [Registered on: 20/06/2023] Trial Registered Prospectively |
| Last Modified On: |
20/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Liver Stiffness in non- obese patient with type 2 diabetes |
|
Scientific Title of Study
|
Assessment of hepatic fibrosis in non- obese patient with type 2 diabetes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr ANOOP MISRA |
| Designation |
Chairman |
| Affiliation |
Fortis CDOC Hospital |
| Address |
Room No 1, Diabetes and Endocrine department
Fortis C-DOC Hospital
B-16 Chirag Enclave Opp Devika Tower, Nehru Place
B-16 Chirag Enclave Opp Devika Tower, Nehru Place
South
DELHI
110048
India |
| Phone |
01149101222 |
| Fax |
|
| Email |
anoopmisra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANOOP MISRA |
| Designation |
Chairman |
| Affiliation |
Fortis CDOC Hospital |
| Address |
Room No 1, Diabetes and Endocrine department
Fortis C-DOC Hospital
B-16 Chirag Enclave Opp Devika Tower, Nehru Place
B-16 Chirag Enclave Opp Devika Tower, Nehru Place
DELHI
110048
India |
| Phone |
01149101222 |
| Fax |
|
| Email |
anoopmisra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANOOP MISRA |
| Designation |
Chairman |
| Affiliation |
Fortis CDOC Hospital |
| Address |
Room No 1, Diabetes and Endocrine department
Fortis C-DOC Hospital
B-16 Chirag Enclave Opp Devika Tower, Nehru Place
B-16 Chirag Enclave Opp Devika Tower, Nehru Place
DELHI
110048
India |
| Phone |
01149101222 |
| Fax |
|
| Email |
anoopmisra@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| KANIKA TYAGI |
Fortis CDOC Hospital |
B-16 Chirag Enclave Opp Devika Tower, Nehru Place
South
DELHI |
01149101222
tyg_knk@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with T2DM (up to 15 years Duration)
2. Age 25 to 60 years
3. BMI < 25 kg/m²
4. Gender- Both
5. USG finding showing definitive fatty liver |
|
| ExclusionCriteria |
| Details |
1. Chronic significant alcohol intake (> 20 gm/day)
2. BMI > 25 kg/m²
3. Congestive heart disease
4. Positive hepatitis B or hepatitis C, secondary causes of fatty liver (eg, consumption of
amiodarone and tamoxifen) and congestive hepatopathy.
5. Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy,
major systemic illness etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses hepatic fat (by CAP) and hepatic fibrosis (by kPA) in Non obese patient with T2DM. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess Liver fibrosis in non-obese type 2 diabetes patients |
6 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)
|
15/07/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The development of type 2 diabetes mellitus (T2DM) is a major public health problem in Asian
Indians. Asian Indians develop T2DM at a younger age, and progresses faster than in other ethnic
groups. As a result, many diabetes complications are more prevalent and in more advanced stages
in Asian countries than in other regions. Asian Indians have one of the highest incidence rates of
pre-diabetes and T2DM among all major ethnic groups, and the conversion from pre-diabetes to
T2DM occurs more rapidly in this population (1). According to the Indian Council of Medical
Research-India diabetes study (n 57117), the prevalence of prediabetes in all 15 states was 7·3%
(1).
Non-alcoholic fatty liver disease (NAFLD) is accumulation of fat in liver in absence of significant
alcohol consumption and other causes of liver diseases. It is estimated that 5-32% Asian Indian
adult population have NAFLD (2). NAFLD is forerunner to obesity, prediabetes and T2DM. The
prevalence rate of NAFLD in T2DM was 12.5%-87.5% in India (3).
Patients with T2DM are at increased risk of NAFLD and have a higher rate of mortality and
progression to cirrhosis (4). Further, high proportion of patients with NAFLD remain
asymptomatic for long periods of time with normal liver tests, non-invasive procedures for early
identification of severe steatosis and advanced fibrosis / cirrhosis are necessary in T2DM
population. Limited number of studies have indicated that liver elastography is a valuable
screening tool for evaluating liver stiffness (5). In the present study we aim to examine the impact
of diabetes on liver fibrosis and to see whether diabetes is a major cause for exacerbating the
incidence of steatohepatitis and liver fibrosis.
This prospective observational study will be of 6 months’ duration where 100 T2DM patients from
urban areas of Delhi will be randomly screened. The population will be representative of different
socio-economic strata of the society. Importantly, large cross sectional and prospective strategies
for prevention of T2DM in Asian Indian population should focus on prediabetes, metabolic
syndrome and NAFLD.
Objectives: To assess Liver fibrosis in non-obese type 2 diabetes patients
Inclusion Criteria:
1. Patients with T2DM (up to 15 years Duration)
2. Age 25 to 60 years
3. BMI < 25 kg/m²
4. Gender- Both
5. USG finding showing definitive fatty liver
Exclusion Criteria:
1. Chronic significant alcohol intake (> 20 gm/day)
2. BMI > 25 kg/m²
3. Congestive heart disease
4. Positive hepatitis B or hepatitis C, secondary causes of fatty liver (eg, consumption of
amiodarone and tamoxifen) and congestive hepatopathy.
5. Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy,
major systemic illness etc. |