Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2
NCT03638843
Bariatric Surgery Candidate, Body Weight
Baltimore, Maryland, United States
View Trial DetailsNCT Number: NCT07737860
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.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Observational
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
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
Measured using BIA, Resting energy expenditure will be measured using an indirect colorimeter if feasible.
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
Interleukin 6 (IL 6) High sensitivity C reactive protein (Hs CRP) Erythrocyte Sedimentation Rate (ESR)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline, 3 months, and 6 months
Percentage body fat will be measured using Bioelectrical Impedance Analysis (BIA).
Time frame: Baseline, 3 months, and 6 months
Skeletal Muscle Index will be calculated as appendicular skeletal muscle mass divided by height squared.
Time frame: Baseline, 3 months, and 6 months
Hand grip strength will be measured using a calibrated hand dynamometer.
Contact information is provided by the study sponsor or research team.
Prakash K Sasmal, MBBS, MS(General Surgery), FMB
CONTACT
Shahadat Hussain, MBBS
CONTACT
All India Institute of Medical Sciences, Bhubaneswar
Other
Impact of Bariatric Surgery on Body Composition, Basal Metabolic Rates and Muscle Functions in Morbid Obese Patients: A Prospective Observational Study
Acronym: BARCOM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03638843
Bariatric Surgery Candidate, Body Weight
Baltimore, Maryland, United States
View Trial DetailsNCT03526263
Bariatric Surgery Candidate, Body Weight
Baltimore, Maryland, United States
View Trial DetailsNCT06299644
Body Weight, Body Weight Changes
Boston, Massachusetts, United States
View Trial DetailsNCT06287307
Body Weight, Body Weight Changes
View Trial Details