Body Composition Outcomes in MS Patients
ConditionObesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPennington Biomedical Research Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Bariatric surgery patients with BMI 40 or more
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 2 trial groupsGroup A: Cohort 1
Group B: Cohort 2
Trial outcomes
Primary outcomes
1
Evaluate the effectiveness of Bioimpedance Analysis (BIA) in assessing outcomes in patients with severe obesity undergoing metabolic surgery (MS).
Measurement of weight in kilograms
Time frame
Baseline and 6 months2
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)
Time frame
Baseline and 6 months3
Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS
height in meters
Time frame
Baseline and 6 months4
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
Time frame
Baseline and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Pennington Biomedical Research Center
Lead sponsor
Our Lady of the Lake Hospital
Collaborator
Source ClinicalTrials.gov