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

NCT07737860 | Not Yet Recruiting

• 1 other identifier: AIIMSBBSR/PGThesis/2025-26/27
• Study Type: observational
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

1. 1.To assess changes in BMR in obese patients following bariatric surgery
2. 2.To evaluate muscles strength and muscle performance parameters in obese patients following bariatric surgery
3. 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.

Conditions

Obesity, Morbid; Obesity; Endocrine; Fat Disorder

Keywords

BMR; Fat composition; Muscle strength

Outcome Measures

Primary Outcomes (1)

• Change in Percentage Body Fat

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

  Baseline, 3 months, and 6 months

Secondary Outcomes (2)

• Change in Skeletal Muscle Mass (kg)

  Baseline, 3 months, and 6 months

• Change in Hand Grip Strength

  Baseline, 3 months, and 6 months

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Morbidly obese patients undergoing bariatric / Metabolic surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metabolic Diseases

Central Study Contacts

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

CONTACT

+919438884255; drpksasmal@gmail.com

Shahadat Hussain, MBBS

CONTACT

+918405851856; mshussain.aiimsj@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General Surgery

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07