An observational study in Obesity, sponsored by Peter Nau. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-20.
Sponsored by Peter Nau · Observational
Obesity is an important public health issue worldwide. In the United States, the percentage of overweight and obese adults increased from 47 and 15%, respectively, to 69 and 36% in the last 40 years. Medically supervised attempts at weight loss are fraught with failures and recidivism. Surgical approaches to this important issue are both durable and effective. The gold standard approach to the surgical treatment of obesity and the attendant medical comorbidities is the laparoscopic roux-en-y gastric bypass (RYGB) and the laparoscopic sleeve gastrectomy (LSG). The mechanisms by which these two operations work and the associated side effects are not completely understood. It is established that the RYGB induces changes in both the fatty tissue mass (FTM) and lean body mass (LBM) post-operatively. This is associated with decreases in bone mineral density, basal metabolic rate, and potentially the ability to maintain weight loss. There is only incomplete information on the influence that the LSG has on body composition. This study proposes an evaluation of the changes in body composition that occurs following these two disparate operations. Using serial measurements by the BodPod and collecting information on the patients' dietary intake, exercise habits and comorbidity resolution, this study will help to better define the influence that the LSG has on body composition. It is hypothesized that the addition of a malabsorptive component will result in increased speed weight loss and overall weight loss which will have a negative impact in the preservation of lean tissue mass for the patient. This information can then be used by bariatric surgeons to better cater the surgical procedure and post-operative plan to the patient's body make up and medical comorbidities.
Procedures
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 136 is close to the median of 135 across 1,283 observational studies indexed under Obesity.
Browse Obesity studies →This is the only study on the registry with Peter Nau as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The population consists of individuals who meet the NIH consensus statement for the surgical treatment of obesity. These individuals will have a BMI greater than 35 kg/m2 and a medical comorbidity or 40 kg/m2. These subjects will have voluntarily initiated a consultation for bariatric surgery and completed the pre-bariatric surgery weight management program. After failing this program, the patients will undergo surgical consultation for bariatric surgery. It is only after this consultation that the subjects will be approached for enrollement in the study.
Exclusion Criteria:
This population will undergo a laparoscopic roux-en-y gastric bypass
Procedure: Bariatric Surgery
This group will undergo a laparoscopic sleeve gastrectomy
Procedure: Bariatric Surgery
Patients enrolled will undergo either a laparoscopic Roux-en-y Gastric Bypass or laparoscopic Sleeve Gastrectomy. The determination of which operation performed will be made independent of patients' enrollment in the study.
Body Composition
Using the BodPod machine produced by Cosmed, changes in lean tissue mass and fatty tissue mass following either the laparoscopic roux-en-y gastric bypass or the laparoscopic sleeve gastrectomy will be assessed.
Time frame: Pre-op, 6 months and 12 months post-op
Comorbidity resolution
Assess for correlations between the changes in body composition and the resolution of medical comorbidities when comparing the LSG and RYGB. This will be done using changes in medication regimen and changes in physical findings and laboratory values such as blood pressure and HbA1c.
Time frame: pre-op, 6 months post-op, 12 months post-op
Protein intake and lean tissue mass
Assess for correlation between the preservation of lean tissue mass and daily protein intake and whether the type of operation (roux-en-y gastric bypass and sleeve gastrectomy) plays a role.
Time frame: Pre-op, 6 months post-op, 12 months post-op
Exercise and lean tissue mass preservation
Test for a correlation between the changes in body composition and the amount of physical activity the patient takes part in and whether this is influenced by the type of procedure the patient had (roux-en-y gastric bypass versus sleeve gastrectomy).
Time frame: Pre-op, 6 months post-op, 12 months post-op
Plan to share: No
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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