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AzTrials

Obesity, MorbidBARCOMNCT07737860

Impact of MBS on Body Composition, Basal Metabolic Rates and Muscle Functions in Morbid Obese Patients

An observational study of Obesity, Morbid and Obesity; Endocrine, run by All India Institute of Medical Sciences, Bhubaneswar.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

PRIMARY OBJECTIVE To evaluate the changes in body composition in morbid obese patients following bariatric and metabolic surgery Secondary Objectives: 1. To assess changes in BMR in obese patients following bariatric surgery 2. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity, Morbid, Obesity; Endocrine, Fat Disorder
How many people
21 participants
Where
No sites listed yet
Study dates
1 Sep 2026to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Morbidly obese patients undergoing bariatric / Metabolic surgery

Who may be able to join

  • BMI > 35 with or without obesity-related comorbidities Planned for Bariatric and Metabolic Surgery

Who cannot join

  • Known endocrine disorders (Cushing's and Untreated hypothyroidism)
  • History of prior bariatric surgery
  • Inability to comply with follow-up scheduleLost to follow-up before 3 months post-treatment

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Prakash K Sasmal, MBBS, MS(General Surgery), FMB contact

+919438884255

drpksasmal@gmail.com

Shahadat Hussain, MBBS contact

+918405851856

mshussain.aiimsj@gmail.com

About this study

Official title: Impact of Bariatric Surgery on Body Composition, Basal Metabolic Rates and Muscle Functions in Morbid Obese Patients: A Prospective Observational Study

PRIMARY OBJECTIVE To evaluate the changes in body composition in morbid obese patients following bariatric and metabolic surgery

Secondary Objectives:

  1. To assess changes in BMR in obese patients following bariatric surgery
  2. To evaluate muscles strength and muscle performance parameters in obese patients following bariatric surgery
  3. To assess change in inflammatory and metabolic parameters following bariatric surgery 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.
Read the detailed description

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

  1. Anthropometric Measurements: Height (Ht) - measured using a stadiometer Weight (Wt) - measured using a digital weighing scale Body Mass Index (BMI) - calculated as Weight/(Height)2. Kg/m² Waist-Hip Ratio (WHR) - using a measuring tape to assess fat distribution
  2. Body Composition Analysis. Body composition analysis will be done using multi-frequency BIA (model InBody370S). Cases will be asked to ensure sufficient hydration before undergoing BIA and patients with electrical implants will be refrained from using BIA. The machine will provide following parameter 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
  3. Basal Metabolic Rate (BMR): Measured using BIA, Resting energy expenditure will be measured using an indirect colorimeter if feasible.
  4. Muscle Function Assessment: Muscle Strength: Upper limbs muscle strength will be assessed by using Hand held dynamometer, which will measure hand grip strength(HGS).Three readings will be taken at an interval of 1 minute of rest. The average of 3 readings will be taken as HGS for each arm.A value of less than 28 in men and less than 18 in women will be considered as low HGS(6). Muscle Performance: A 6 meter walk test is a reliable test to assess muscle function or physical performance. A gait speed of less than 1 metre/second will be considered as reduced physical performance
  5. Inflammatory Markers: Interleukin 6 (IL 6) High sensitivity C reactive protein (Hs CRP) Erythrocyte Sedimentation Rate (ESR)
  6. Metabolic Parameters:

In this study, a comprehensive panel of metabolic and biochemical parameters will be assessed to evaluate the systemic effects of bariatric surgery. Glycemic control will be monitored through FBS, PPBS and HbA1c. Thyroid function will be evaluated by measuring thyroid stimulating hormone (TSH). Renal function will be assessed using serum urea and creatinine levels, urine ACR, while liver function will be evaluated through total bilirubin, AST, ALT, ALP estimation. Lipid metabolism will be examined by measuring total cholesterol, triglycerides, LDLand HDL. Additionally, serum calcium, VitD3 will be included to monitor bone and mineral metabolism, which may be affected by significant weight loss or changes in nutritional status postoperatively. These parameters will provide a holistic view of the physiological changes and health improvements resulting from bariatric surgery.

Follow-up: 3 and 6 months postoperative

Statistical analysis plan:

Data will be managed in Microsoft Excel and analysed using SPSS version 26. Numerical data like BMR, fat mass, etc., will be shown as mean ± SD or median with range.Categorical values like gender and type of surgery will be expressed as percentages.Kolmogorov-Smirnov test will be used to check for normality of continuous variables.Depending on data type, either parametric or non-parametric tests will be applied. All final outcomes will be shown with 95% confidence intervals.A p-value of <0.05 will be kept as a significant threshold.

Keywords
BMR, Fat composition, Muscle strength
Medical subject headings
Obesity, Morbid, Obesity, Lipid Metabolism Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Percentage Body Fat

    Percentage body fat will be measured using Bioelectrical Impedance Analysis (BIA).

    Measured: Baseline, 3 months, and 6 months

Secondary outcomes (2)
  1. Change in Skeletal Muscle Mass (kg)

    Skeletal Muscle Index will be calculated as appendicular skeletal muscle mass divided by height squared.

    Measured: Baseline, 3 months, and 6 months

  2. Change in Hand Grip Strength

    Hand grip strength will be measured using a calibrated hand dynamometer.

    Measured: Baseline, 3 months, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07737860
Sponsor's protocol ID
AIIMSBBSR/PGThesis/2025-26/27
Acronym
BARCOM
Status last verified
Jul 2026
First submitted
16 Feb 2026
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, Morbid and Obesity; Endocrine, run by All India Institute of Medical Sciences, Bhubaneswar.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Prakash K Sasmal, MBBS, MS(General Surgery), FMB (+919438884255, drpksasmal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Percentage Body Fat (time frame: Baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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