| CTRI Number |
CTRI/2025/11/097782 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Bariatric Surgery on Body Composition, Basal Metabolic Rates and Muscle functions in Morbid Obese Patient |
|
Scientific Title of Study
|
Impact of BAriatric Surgery on Body COmposition, Basal Metabolic Rates and Muscle functions in Morbid Obese Patient: A Prospective Observational Study |
| Trial Acronym |
BARCOM Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prakash Kumar Sasmal |
| Designation |
Professor, Department of General Surgery, AIIMS Bhubaneswar. |
| Affiliation |
AIIMS bhubaneswar |
| Address |
Room no - 67, General Surgery OPD, AIIMS BHUBANESWAR Bhubaneswar 751019, Odisha
Khordha
ORISSA
751019
India |
| Phone |
9861143399 |
| Fax |
|
| Email |
drpksasmal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Md Shahadat Hussain |
| Designation |
Junior Resident, AIIMS bhubaneswar |
| Affiliation |
AIIMS bhubaneswar |
| Address |
Room no - 67, General Surgery OPD, AIIMS BHUBANESWAR Bhubaneswar 751019, Odisha
Khordha
ORISSA
751019
India |
| Phone |
8405851856 |
| Fax |
|
| Email |
mshussain.aiimsj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Md Shahadat Hussain |
| Designation |
Junior Resident, AIIMS bhubaneswar |
| Affiliation |
AIIMS bhubaneswar |
| Address |
Room no - 67, General Surgery OPD, AIIMS BHUBANESWAR Bhubaneswar 751019, Odisha
Khordha
ORISSA
751019
India |
| Phone |
8405851856 |
| Fax |
|
| Email |
mshussain.aiimsj@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
Sijua, Patrapada, Bhubaneswar, Odisha, India, PIN no - 751019 |
| 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 Shahdat Hussain |
AIIMS Bhubaneswar |
Room no 67 OPD General Surgery
Khordha
ORISSA |
8405851856
mdhussain9631@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z683||Body mass index (BMI) 30-39, adult, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
BMI more than 35 with or without obesity-related comorbidities
Planned for Bariatric and Metabolic Surgery
|
|
| ExclusionCriteria |
| Details |
Known endocrine disorders (Cushing’s and Untreated
hypothyroidism
History of prior bariatric surgery
Inability to comply with follow-up Schedules to follow-up before 3 months post-treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Body Mass Index (BMI) , Waist-Hip Ratio (WHR),
PBF (Percentage Body Fat) – to assess total fat content
SMM (Segmental Muscle Mass) – to evaluate muscle mass in individual limbs and trunk
SFM (Segmental Fat Mass) – to quantify regional fat distribution
SMI (Skeletal Muscle Index) – to assess skeletal muscle mass adjusted for height |
baseline, 3rd month and 6th Month of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in REE and BMR, Change in Muscle strength and muscle performance |
At the time of Surgery, At 3rd month and 6th Month of surgery |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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)
|
02/12/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prospective Observational Cohort study, In this study, morbidly obese patients undergoing bariatric surgery will be assessed at baseline and followed by 3rd and 6 months to evaluate various physiological and biochemical changes. Anthropometric measurements including height, weight, BMI, and waist-hip ratio will be recorded. Body composition will be assessed using Bioelectrical Impedance Analysis (BIA), which will provide data on percentage body fat (PBF), segmental muscle mass (SMM), segmental fat mass (SFM), and skeletal muscle index (SMI). Basal metabolic rate (BMR) will also be measured through BIA. Muscle strength will be evaluated using a hand grip dynamometer, while muscle performance will be assessed via gait speed using the 6-meter walk test. Inflammatory markers such as high-sensitivity C-reactive protein (HsCRP), erythrocyte sedimentation rate (ESR), and interleukin-6 (IL-6) will be analyzed. Additionally, metabolic parameters including thyroid-stimulating hormone (TSH), fasting and postprandial blood glucose, HbA1c, and lipid profile will be measured to understand the systemic effects of the surgery. |