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.
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.
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:
- To assess changes in BMR in obese patients following bariatric surgery
- To evaluate muscles strength and muscle performance parameters in obese patients following bariatric surgery
- 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
- 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
- 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
- Basal Metabolic Rate (BMR): Measured using BIA, Resting energy expenditure will be measured using an indirect colorimeter if feasible.
- 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
- Inflammatory Markers: Interleukin 6 (IL 6) High sensitivity C reactive protein (Hs CRP) Erythrocyte Sedimentation Rate (ESR)
- 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.
- Conditions
- Obesity, Morbid, Obesity; Endocrine, Fat Disorder
- 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.
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)
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
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.
- First posted30 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Prakash Kumar Sasmal, All India Institute of Medical Sciences, Bhubaneswar
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bariatric Surgery on Body Composition, Basal Metabolic Rates and Muscle Functions in Morbid Obese Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07737860
- Acronym / sponsor ID
- BARCOM / AIIMSBBSR/PGThesis/2025-26/27
- Conditions
- Obesity, Morbid, Obesity; Endocrine, Fat Disorder
- Keywords
- BMR, Fat composition, Muscle strength
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PRIMARY OBJECTIVE To evaluate the changes in body composition in morbid obese patients following bariatric and metabolic surgery
Secondary Objectives:
- To assess changes in BMR in obese patients following bariatric surgery
- To evaluate muscles strength and muscle performance parameters in obese patients following bariatric surgery
- 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.
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
- 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
- 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
- Basal Metabolic Rate (BMR): Measured using BIA, Resting energy expenditure will be measured using an indirect colorimeter if feasible.
- 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
- Inflammatory Markers: Interleukin 6 (IL 6) High sensitivity C reactive protein (Hs CRP) Erythrocyte Sedimentation Rate (ESR)
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Morbidly obese patients undergoing bariatric / Metabolic surgery
Key inclusion criteria (1 listed)
- BMI > 35 with or without obesity-related comorbidities Planned for Bariatric and Metabolic Surgery
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Percentage Body Fat
Time frame: Baseline, 3 months, and 6 months
Percentage body fat will be measured using Bioelectrical Impedance Analysis (BIA).
2 secondary outcomes
Change in Skeletal Muscle Mass (kg)
Time frame: Baseline, 3 months, and 6 months
Change in Hand Grip Strength
Time frame: Baseline, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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.