ClinicalTrials.gg
Not yet recruitingNCT07737860BARCOMUpdated Jul 30, 2026

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

An observational study in Obesity, Morbid, Obesity; Endocrine and Fat Disorder, sponsored by All India Institute of Medical Sciences, Bhubaneswar. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by All India Institute of Medical Sciences, Bhubaneswar · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
21
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Obesity, Morbid
  • Obesity; Endocrine
  • Fat Disorder

Keywords

  • BMR
  • Fat composition
  • Muscle strength
03

In context

Obesity, Morbid

941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.

This study's planned enrollment of 21 is below the median of 80 across 311 observational studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar is the lead sponsor of 59 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Morbidly obese patients undergoing bariatric / Metabolic surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
21 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Change in Percentage Body Fat

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

    Time frame: Baseline, 3 months, and 6 months

Secondary outcomes

  1. Change in Skeletal Muscle Mass (kg)

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

    Time frame: Baseline, 3 months, and 6 months

  2. Change in Hand Grip Strength

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

    Time frame: Baseline, 3 months, and 6 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.

Of 137 non-industry observational studies under Obesity, Morbid, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 132. This study's planned 9 months is below that.

Counting every sponsor, half of 138 studies reached it within 46 months; a quarter within 16 and three quarters within 132.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2026
First posted
Jul 30, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Jun 2027
CompletionEst.
Dec 2027
Last update
Jul 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07737860
Lead sponsor
All India Institute of Medical Sciences, Bhubaneswar
Responsible party
Dr. Prakash Kumar Sasmal (Professor of General Surgery, All India Institute of Medical Sciences, Bhubaneswar) — Principal investigator
First posted
Jul 30, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 30, 2026

Study contacts

Prakash K Sasmal, MBBS, MS(General Surgery), FMB
Contact
drpksasmal@gmail.com
+919438884255
Shahadat Hussain, MBBS
Contact
mshussain.aiimsj@gmail.com
+918405851856

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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