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NCT07737860
Impact of MBS on Body Composition, Basal Metabolic Rates and Muscle Functions in Morbid Obese Patients
Conditions: Obesity, Morbid, Obesity; Endocrine, Fat Disorder
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Enrollment: 21
Sponsor: All India Institute of Medical Sciences, Bhubaneswar
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.
Eligibility Criteria
Inclusion Criteria:
* BMI \> 35 with or without obesity-related comorbidities Planned for Bariatric and Metabolic Surgery
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
Source: ClinicalTrials.gov (NCT07737860). StuddyBuddy aggregates publicly available trial information.