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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  
AIIMS New Delhi 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Ansari Nagar, New Delhi, Delhi 110029  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response (Others) - 

  2. What additional supporting information will be shared?
    Response (Others) - 
  3. Who will be able to view these files?
    Response (Others) - 

  4. For what types of analyses will this data be available?
    Response (Others) - 

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-09-2022 and end date provided 01-09-2027?
    Response (Others) - 

  7. 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.

 
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