Changes in Body Composition Following Bariatric Surgery
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/22/2018 |
| Start Date: | May 2014 |
| End Date: | October 2018 |
Roux-en-y Gastric Bypass Versus Sleeve Gastrectomy - Analysis of the Disparate Effects on Body Composition and Associated Comorbidity Resolution
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.
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
- All patients will undergo a bariatric surgery. The decision to undergo weight loss
surgery and the operation chosen will both occur independent of and prior to enrollment
in the study. The University of Iowa is a Bariatric Center of Excellence with three
active, board-certified bariatric surgeons.
- Serial BodPod examinations will be performed on each patient. The BodPod is a
commercially available device produced by Cosmed. It uses whole-body densitometry to
determine body composition. To do this, it takes small changes in the volume of air in
the BodPod chamber and records the associated changes in pressure. The pressure change
typically goes unnoticed and is equivalent to the change in pressure while moving from
the first floor to the second floor in an elevator. The entire process takes
approximately five minutes with two minutes spent within the machine. The computer will
then use mathematical formulas to calculate various body composition values.
- Laboratory analysis - There is a battery of labs that are ordered in both the
pre-operative and post-operative time frame. These labs are ordered independent of the
patient's participation in the study. These labs are ordered to assist in the management
of the patient's medical comorbidities and to assess for adequate nutritional intake.
These labs will also be recorded in the research database to assist in quantifying the
degree of resolution of medical comorbidities.
- Queries on nutritional intake and exercise will be made at each post-operative
appointment. The intake of protein is an important variable and may influence
maintenance of lean tissue mass. Exercise is an important component of the
post-bariatric weight loss program. This also will influence the changes in lean tissue
mass.
- All patients will undergo a bariatric surgery. The decision to undergo weight loss
surgery and the operation chosen will both occur independent of and prior to enrollment
in the study. The University of Iowa is a Bariatric Center of Excellence with three
active, board-certified bariatric surgeons.
- Serial BodPod examinations will be performed on each patient. The BodPod is a
commercially available device produced by Cosmed. It uses whole-body densitometry to
determine body composition. To do this, it takes small changes in the volume of air in
the BodPod chamber and records the associated changes in pressure. The pressure change
typically goes unnoticed and is equivalent to the change in pressure while moving from
the first floor to the second floor in an elevator. The entire process takes
approximately five minutes with two minutes spent within the machine. The computer will
then use mathematical formulas to calculate various body composition values.
- Laboratory analysis - There is a battery of labs that are ordered in both the
pre-operative and post-operative time frame. These labs are ordered independent of the
patient's participation in the study. These labs are ordered to assist in the management
of the patient's medical comorbidities and to assess for adequate nutritional intake.
These labs will also be recorded in the research database to assist in quantifying the
degree of resolution of medical comorbidities.
- Queries on nutritional intake and exercise will be made at each post-operative
appointment. The intake of protein is an important variable and may influence
maintenance of lean tissue mass. Exercise is an important component of the
post-bariatric weight loss program. This also will influence the changes in lean tissue
mass.
Inclusion Criteria:
- Individuals will have a BMI greater than 35 kg/m2 and a medical comorbidity or 40
kg/m2
- Individuals must have voluntarily initiated a surgical consultation for weight loss
surgery
- Individuals must have completed a medical supervised weight loss program
Exclusion Criteria:
- Failure to adequately complete the pre-screening and educational program necessary to
proceed with bariatric surgery
- Those who are or become pregnant
- Individuals with severe claustrophobia.
We found this trial at
1
site
200 Hawkins Dr,
Iowa City, Iowa 52242
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Peter N Nau, MD, MS
Phone: 319-356-7675
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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