Recruiting

Body Composition Measurement

Sponsor:

Pennington Biomedical Research Center

Code:

NCT07530718

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07530718

Start date

Apr 14, 2026

Status verified date

Nov, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Roux-en-Y gastric bypass surgery

Cohort 2

Sleeve Gastrectomy

Primary outcome measure

  • Evaluate the effectiveness of Bioimpedance Analysis (BIA) in assessing outcomes in patients with severe obesity undergoing metabolic surgery (MS). [ Time Frame: Baseline and 6 months ]
  • Evaluate the effectiveness of Leg Strength and Endurance Testing in assessing outcomes in patients with severe obesity undergoing MS. [ Time Frame: Baseline and 6 months ]
  • Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS [ Time Frame: Baseline and 6 months ]
  • Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS [ Time Frame: 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 [ Time Frame: Baseline and 6 months ]
  • Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS [ Time Frame: Baseline and 6 months ]
  • Evaluate the effectiveness of anthropometric measurement tool in assessing outcomes in patients with severe obesity undergoing MS [ Time Frame: Baseline and 6 months ]
  • Evaluate the effectiveness of anthropometric measurement tool in assessing outcomes in patients with severe obesity undergoing MS [ Time Frame: Baseline and 6 months ]
  • Evaluate the effectiveness of BIA measurement tool in assessing outcomes in patients with severe obesity undergoing MS [ Time Frame: Baseline and 6 months ]
  • Evaluate the effectiveness of anthropometric measurement tools in assessing outcomes in patients with severe obesity undergoing MS [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline and 6 months ]
  • Evaluate the effectiveness of Six-Minute Walk testing in assessing outcomes in patients with severe obesity undergoing MS. [ Time Frame: Baseline and 6 months ]
  • Evaluate the effectiveness of 3D Optical Imaging in assessing outcomes in patients with severe obesity undergoing MS. [ Time Frame: Baseline and 6 months ]
  • Evaluate the effectiveness of BodPod (Air Displacement Plethysmography) in assessing outcomes in patients with severe obesity undergoing MS [ Time Frame: Baseline and 6 months ]
  • Evaluate the effectiveness of BodPod in assessing outcomes in patients with severe obesity undergoing MS. [ Time Frame: Baseline and 6 months ]
  • Evaluate the effectiveness of Dual Energy X ray Absorptiometry (DXA) in assessing outcomes in patients with severe obesity undergoing MS [ Time Frame: Baseline and 6 months ]
  • Evaluate the effectiveness of DXA in assessing outcomes in patients with severe obesity undergoing MS [ Time Frame: Baseline and 6 months ]
  • Evaluate the effectiveness of Deuterium & Bromide Dilution in assessing outcomes in patients with severe obesity undergoing metabolic surgery (MS). [ Time Frame: Baseline and 6 months ]
  • Evaluate the effectiveness of Deuterium & Bromide Dilution in assessing outcomes in patients with severe obesity undergoing MS. [ Time Frame: Baseline and 6 months ]

Central Contacts and Locations

Central contacts

Zubaidah Nor Hanipah, MD

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

Locations

Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Zubaidah Nor Hanipah, MD

2257632831Zubaidah.Norhanipah@pbrc.edu

More Information

Sponsor

Pennington Biomedical Research Center

Last update posted

Jun 17, 2026

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pennington Biomedical Research Center on 2026-06-17.