Body Composition Outcomes in MS Patients

NCT07530718 | Not Yet Recruiting

• 1 other identifier: 2025-012
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives The objective of this project is to generate pilot data substantiating our hypothesis that advanced body composition measurement tools will provide more accurate and clinically relevant data on the outcomes of metabolic surgery (MS) in patients with severe obesity compared to traditional methods. To achieve this objective, the investigators propose the following aims: Aim 1: Evaluate the effectiveness of different body composition measurement tools in assessing outcomes in patients with severe obesity undergoing MS. Aim 2: Assess the changes in body composition and muscle strength following MS. Aim 3: Compare body compositions changes between SG and RYGB patients.

Conditions

Obesity

Keywords

Obesity; Bariatric surgery; skeletal muscle; adipose tissue; weight loss

Outcome Measures

Primary Outcomes (20)

• Evaluate the effectiveness of Bioimpedance Analysis (BIA) in assessing outcomes in patients with severe obesity undergoing metabolic surgery (MS).

  Measurement of weight in kilograms

  Baseline and 6 months

• Evaluate the effectiveness of Leg Strength and Endurance Testing in assessing outcomes in patients with severe obesity undergoing MS.

  Leg muscle strength measured in in Newton-meters (Nm)

  Baseline and 6 months

• Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS

  height in meters

  Baseline and 6 months

• Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS

  weight and height will be combined to report BMI in kg/m\^2

  Baseline and 6 months

• Evaluate the effectiveness Body MRI in assessing outcomes of body composition in assessing outcomes in patients with severe obesity undergoing MS

  Measure skeletal muscle mass volume in cm\^3

  Baseline and 6 months

• Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS

  body fat percentage in %

  Baseline and 6 months

• Evaluate the effectiveness of anthropometric measurement tool in assessing outcomes in patients with severe obesity undergoing MS

  Measure waist circumference in cm

  Baseline and 6 months

• Evaluate the effectiveness of anthropometric measurement tool in assessing outcomes in patients with severe obesity undergoing MS

  Mid-thigh circumference in cm

  Baseline and 6 months

• Evaluate the effectiveness of BIA measurement tool in assessing outcomes in patients with severe obesity undergoing MS

  weight and height will be combined to report BMI in kg/m\^2

  Baseline and 6 months

• Evaluate the effectiveness of anthropometric measurement tools in assessing outcomes in patients with severe obesity undergoing MS

  Hip circumference in cm

  Baseline and 6 months

• Evaluate the effectiveness Body MRI in assessing outcomes of body composition in assessing outcomes in patients with severe obesity undergoing MS

  Measure visceral adipose tissue volume in cm\^3

  Baseline and 6 months

• Evaluate the effectiveness Body MRI in assessing outcomes of body composition in assessing outcomes in patients with severe obesity undergoing MS

  Measure subcutaneous adipose tissue volume in cm\^3

  Baseline and 6 months

• Evaluate the effectiveness of Six-Minute Walk testing in assessing outcomes in patients with severe obesity undergoing MS.

  Physical endurance will be measured by the distance walked during a 6-minute walk test in meter

  Baseline and 6 months

• Evaluate the effectiveness of 3D Optical Imaging in assessing outcomes in patients with severe obesity undergoing MS.

  Measure body volume in cm\^3

  Baseline and 6 months

• Evaluate the effectiveness of BodPod (Air Displacement Plethysmography) in assessing outcomes in patients with severe obesity undergoing MS

  Measure body volume in liters

  Baseline and 6 months

• Evaluate the effectiveness of BodPod in assessing outcomes in patients with severe obesity undergoing MS.

  Measure body density in kilograms per cubic meter (kg/m\^3)

  Baseline and 6 months

• Evaluate the effectiveness of Dual Energy X ray Absorptiometry (DXA) in assessing outcomes in patients with severe obesity undergoing MS

  Measure total fat mass in kg

  Baseline and 6 months

• Evaluate the effectiveness of DXA in assessing outcomes in patients with severe obesity undergoing MS

  Measure lean mass /fat free mass in kg

  Baseline and 6 months

• Evaluate the effectiveness of Deuterium & Bromide Dilution in assessing outcomes in patients with severe obesity undergoing metabolic surgery (MS).

  Measure total body water in liter

  Baseline and 6 months

• Evaluate the effectiveness of Deuterium & Bromide Dilution in assessing outcomes in patients with severe obesity undergoing MS.

  Measure extracellular water in liters

  Baseline and 6 months

Study Arms (2)

Cohort 1

Roux-en-Y gastric bypass surgery

Cohort 2

Sleeve Gastrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bariatric surgery patients with BMI 40 or more

You may qualify if:

• Being either male or female
• Being an adult greater or equal to 18 years of age
• BMI ≥40 kg/m2
• Weigh less than 440 pounds
• Being willing to comply with the study procedures
• Being scheduled for primary metabolic surgery (either Sleeve Gastrectomy or Roux-en-Y Gastric bypass)

You may not qualify if:

• Previous bariatric surgery or other complex abdominal surgery
• Poorly controlled medical or psychiatric disorders
• For women in child-bearing ages, being pregnant or attempting to become pregnant or currently breastfeeding
• Having metal-containing objects in their body that may cause artifact on MRI
• Having medical implants such as a pacemaker or metal joint replacements
• Having a body weight greater than 440 pounds
• Comorbid conditions that may affect body composition measurements, such as advanced liver disease or severe cardiovascular disease.
• Cannot understand risks, benefits, and compliance required to participate.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Our Lady of the Lake Hospital: collaborator

Study Sites (1)

Pennington Biomedical Resarch Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

• 1. Eisenberg D, Shikora SA, Aarts E, Aminian A, Angrisani L, Cohen RV, De Luca M, Faria SL, Goodpaster KP, Haddad A, Himpens JM. 2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) indications for metabolic and bariatric surgery. 2. Courcoulas AP, Daigle CR, Arterburn DE. Long term outcomes of metabolic/bariatric surgery in adults. BMJ. 2023 Dec 18;383. 3. Pareek M, Schauer PR, Kaplan LM, Leiter LA, Rubino F, Bhatt DL. Metabolic surgery: weight loss, diabetes, and beyond. Journal of the American College of Cardiology. 2018 Feb 13;71(6):670-87. 4. Hanipah ZN, Schauer PR. Bariatric surgery as a long-term treatment for type 2 diabetes/metabolic syndrome. Annual review of medicine. 2020 Jan 27;71(1):1-5. 5. Emmerich SD, Fryar CD, Stierman B, Ogden CL. Obesity and Severe Obesity Prevalence in Adults: United States, August 2021-August 2023. 6. Zhao L, Park S, Ward ZJ, Cradock AL, Gortmaker SL, Blanck HM. Peer Reviewed: State-Specific Prevalence of Severe Obesity Among Adults in the US Using Bias Correction of Self-Reported Body Mass Index. Preventing Chronic Disease. 2023;20. 7. Das SK, Roberts SB, Kehayias JJ, Wang J, Hsu LG, Shikora SA, Saltzman E, McCrory MA. Body composition assessment in extreme obesity and after massive weight loss induced by gastric bypass surgery. American Journal of Physiology-Endocrinology and Metabolism. 2003 Jun 1;284(6):E1080-8. 8. Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. International Journal of Obesity. 2000;24(1):38-48. 9. Meule A, Hermann T, Kübler A. A short version of the Food Cravings Questionnaire-Trait: the FCQ-T-reduced. Frontiers in Psychology. 2014;5:190. 10. Diktas HE, Cardel MI, Foster GD, LeBlanc MM, Dickinson SL, Ables EM, Martin CK. Development and validation of the Food Noise Questionnaire. Obesity. 2

  RESULT

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zubaidah Nor Hanipah, MD

CONTACT

225-763-2831; zubaidah.norhanipah@pbrc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: April 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 17, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)