| CTRI Number |
CTRI/2022/11/047422 [Registered on: 18/11/2022] Trial Registered Prospectively |
| Last Modified On: |
19/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
ASSOCIATION BETWEEN OBESITY PHENOTYPES, METABOLIC HEALTH AND NAFLD |
|
Scientific Title of Study
|
Association between different obesity phenotypes, liver steatosis and fibrosis and metabolic health in adult patients with Non-alcoholic fatty liver disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naval K Vikram |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
A-209, 2nd Floor, New RAK OPD, AIIMS, Delhi All India Institute of Medical Science, Delhi, Ansari Nagar, Aurobindo Marg, New Delhi - 110029, India New Delhi DELHI 110029 India |
| Phone |
9810007331 |
| Fax |
|
| Email |
navalvikram@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Naval K Vikram |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
A-209, 2nd Floor, New RAK OPD, AIIMS, Delhi All India Institute of Medical Science, Delhi, Ansari Nagar, Aurobindo Marg, New Delhi - 110029, India New Delhi DELHI 110029 India |
| Phone |
9810007331 |
| Fax |
|
| Email |
navalvikram@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Naval K Vikram |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
A-209, 2nd Floor, New RAK OPD, AIIMS, Delhi All India Institute of Medical Science, Delhi, Ansari Nagar, Aurobindo Marg, New Delhi - 110029, India New Delhi DELHI 110029 India |
| Phone |
9810007331 |
| Fax |
|
| Email |
navalvikram@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Ansari Nagar, New Delhi, Delhi 110029
|
| 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 |
| Naval K Vikram |
AIIMS Delhi |
Room A-209, Department of Medicine, New RAK OPD, Ansari Nagar, New Delhi, Delhi 110029
New Delhi DELHI |
9810007331
navalvikram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, AIIMS, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
OBSERVATIONAL STUDY |
| Comparator Agent |
NIL |
OBSERVATIONAL STUDY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-60 years
Diagnosed with non- alcoholic fatty liver disease
BMI above 18.5 kg/m2
|
|
| ExclusionCriteria |
| Details |
Known case or recently diagnosed diabetes mellitus
Acute infection and advanced end organ damage
History of pancreatitis
Participants undergone any recent surgery
On any medication within last one month which could potentially influence insulin secretion, insulin sensitivity
Pregnancy and lactation at the time of study.
Chronic heart disease and chronic kidney disease
Acute and chronic hepatitis
Excessive alcohol use (>20 g a day for women and >30 g for men)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Liver steatosis, liver fibrosis, biochemical and metabolic parameters (lipid profile, liver health markers and anthropometric parameters) |
One Time (At baseline only) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ASCVD risk score, FIB-4 Score, NFS Score, Muscle strength, quality of life and sleep quality |
One Time (At Baseline only) |
|
|
Target Sample Size
|
Total Sample Size="400" Sample Size from India="400"
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)
|
01/12/2022 |
| 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="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response (Others) -
- Who will be able to view these files?
Response (Others) -
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-09-2022 and end date provided 01-09-2027?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - None
|
|
Brief Summary
|
Non-alcoholic fatty liver disease (NAFLD) represents a major global healthcare challenge in the twenty first century. NAFLD has emerged as one of the leading causes of cirrhosis, hepatocellular carcinoma and liver transplant in India. Prevalence of the disease is estimated to be around 9-32% in the general Indian population, with a higher incidence rate amongst obese and diabetic patients. Researchers have suggested that NAFLD can be regarded as hepatic manifestation of metabolic syndrome. Overweight and obesity are the main drivers of metabolic disease and NAFLD. Nevertheless, not all obese are metabolically unhealthy, neither all normal weight /lean are metabolically healthy. Being normal weight with metabolic abnormalities was also associated with risk of NAFLD. The link between NAFLD and metabolic syndrome is more complex that previously thought. Indeed the metabolic syndrome shows mutual and bi-directional associations with NAFLD such that NAFLD is now considered to be both a cause and consequence of metabolic syndrome. Future research is required to better understand the association between NAFLD, obesity phenotypes and metabolic syndrome. So, The present study will aim to find the association between NAFLD and different obesity phenotypes (Metabolically healthy non obese (MHNO), Metabolically healthy obese (MHO), Metabolically unhealthy non obese (MUNO), Metabolically unhealthy obese (MUO) among study population. This will be a cross sectional observational study, all the patients attending Out Patient Department (OPD) of Tertiary Care Hospital in Delhi will be screened for inclusion and exclusion criteria. Both male and female aged between 18-60 years and are diagnosed with fatty liver with a BMI above 18.5 kg/m2 will be recruited in the study and the patients diagnosed with diabetes mellitus, have any end organ damage, or have any history of pancreatitis will be excluded from the study. Approval from Institutional Ethical Committee (IEC) from Lady Irwin college and tertiary care hospital will be obtained before conducting the study. A written consent will be obtained and study information sheet will be given to each participant. Different tools and techniques will be used for data collection. All the participants will undergo fibroscan analysis for NAFLD diagnosis, clinical, anthropometry, biochemical and dietary data will also be obtained. Proir to data collection, pilot testing of all the tools will be done. All the data obtained through questionnaire, anthropometric measurement and dietary intake will be cleaned, coded and computerized using Microsoft Excel 2007 and SPSS software (version 24.0). Missing data will be checked to prevent errors. The qualitative data will be treated to obtain frequencies and percentages. Mean, median, standard deviation and range will be obtained using quantitative data. Karl pearson’s correlation test will be used to find association between different variables. Dietary data will entered in Diet Cal software and will be compared with the recommendations given by ICMR. |