Changes in Body Composition Following Bariatric Surgery

NCT02148068 | Completed DMC

• 1 other identifier: 201310819
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

Obesity; Bariatric Surgery; Roux-en-y Gastric Bypass; Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-op, 6 months and 12 months post-op

Secondary Outcomes (3)

• Comorbidity resolution

  pre-op, 6 months post-op, 12 months post-op

• Protein intake and lean tissue mass

  Pre-op, 6 months post-op, 12 months post-op

• Exercise and lean tissue mass preservation

  Pre-op, 6 months post-op, 12 months post-op

Study Arms (2)

Bariatric Surgery - Gastric Bypass

This population will undergo a laparoscopic roux-en-y gastric bypass

Procedure: Bariatric Surgery

Bariatric Surgery - Sleeve Gastrectomy

This group will undergo a laparoscopic sleeve gastrectomy

Procedure: Bariatric Surgery

Interventions

Bariatric Surgery PROCEDURE

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.

Bariatric Surgery - Gastric Bypass; Bariatric Surgery - Sleeve Gastrectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peter Nau: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (15)

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MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Peter N Nau, MD, MS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 28, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)