| CTRI Number |
CTRI/2020/10/028460 [Registered on: 19/10/2020] Trial Registered Prospectively |
| Last Modified On: |
16/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic
Other (Specify) [Biopsy] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Molecular and structural characters of body fat in obese person |
|
Scientific Title of Study
|
Molecular and morphological characterization of superficial, deep and visceral adipose tissue in human obesity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Veena L Karanth |
| Designation |
Professor and Unit Chief |
| Affiliation |
Kasturba Medical college and Hospital |
| Address |
Kasturba Medical College and Hospital, Manipal, Udupi- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845417715 |
| Fax |
|
| Email |
veena.karanth@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena L Karanth |
| Designation |
Professor and Unit Chief |
| Affiliation |
Kasturba Medical college and Hospital |
| Address |
Kasturba Medical College and Hospital, Manipal, Udupi- 576104
KARNATAKA
576104
India |
| Phone |
9845417715 |
| Fax |
|
| Email |
veena.karanth@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena L Karanth |
| Designation |
Professor and Unit Chief |
| Affiliation |
Kasturba Medical college and Hospital |
| Address |
Kasturba Medical College and Hospital, Manipal, Udupi- 576104
KARNATAKA
576104
India |
| Phone |
9845417715 |
| Fax |
|
| Email |
veena.karanth@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, Manipal- 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College and Hospital |
| Address |
Kasturba Medical College and Hospital, Manipal, Udupi- 576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MAHE intramural fund through seed money and Dr TMA Pai Endowment Chair |
Kasturba Medical College and Hospital, Manipal, Udupi- 576104 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr L Veena Karanth |
Kasturba Medical College and Hospital |
Department of Surgery and Molecular neuroscience, Kasturba Medical College and Hospital, Manipal, Udupi- 576104
Udupi
KARNATAKA |
9845417715
veena.karanth@manipal.edu |
|
|
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: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nonobese patient |
Includes female patients who are non obese (BMI24.9 kg/m2) and undergoing surgery at surgery Unit 2 |
| Intervention |
obese patients |
Female patients who are obese (BMI30 kg/m2) and undergoing surgery at surgery Unit 2. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Includes female patients who are obese (BMI>30 kg/m2) and undergoing surgery at surgery Unit 2.
2. Includes female patients who are non-obese (BMI<24.9 kg/m2) and undergoing surgery at surgery Unit 2.
3. Females who are 20-40 years of age. |
|
| ExclusionCriteria |
| Details |
1. Those who have HIV, COVID 19 etc and potential pathogens requiring BSL2 handling procedures.
2. The subjects undergoing any form of hormonal therapy at the time of surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Molecular and morphological differences in adipose tissue among obese and nonobese will help to modify the treatment modalities among obes |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Molecular and morphological differences in adipose tissue among obese and non obese will help to modify the treatment modalities among obese and identify the associated comorbidity due to obesity. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
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)
|
19/10/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Obesity has reached ‘epidemic’ levels across the world, challenging healthcare systems and economies in developed and developing countries. The national prevalence of obesity is 3.4%. Worldwide there are 4% of diabetes cases, 23%of ischemic heart disease, and 7–41% of certain cancers attributable to overweight and obesity. This occurs, at least partially, because of the obesity-induced insulin resistance. Adipose tissue is not only an energy reservoir but also a secretory endocrine organ of cytokines, hormones, and proteins that affect the functionality of cells and tissues all over the body. The role of SAT sub compartments is not well understood. SAT, conventionally regarded as a homogenous compartment, is anatomically separated by a stromal fascia into superficial (sSAT) and deep subcutaneous adipose tissue (dSAT). Adipose tissue can affect other tissues via endocrine, paracrine, and autocrine signals. Visceral Adipose tissue (VAT) accumulation has unique biochemical characteristics that influence several normal and pathological processes in the human body. VAT and SAT depots, show subject-to-subject variation, dependent on age, gender, ethnicity, nutritional intake, and the autonomic regulation of energy homeostasis. The increasing evidence of the complexity of fat metabolic patterns emphasizes the importance of studying adipose tissue at anatomic, cellular and molecular levels. In this study, RNA sequencing techniques will be employed for better investigation of the 3 specimens of fat in severely obese patients and non obese patients, aiming to further identify their specific molecular and morphological signatures. This will help us identify molecular genetic targets and/or pathways that are altered in obese individuals as compared to normative controls. differences. |