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Changes in Body Composition Following Bariatric Surgery

19 novembre 2018 aggiornato da: Peter Nau

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

136

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Iowa
      • Iowa City, Iowa, Stati Uniti, 52242
        • University of Iowa Hospitals and Clinics

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Bariatric Surgery - Gastric Bypass
This population will undergo a laparoscopic roux-en-y gastric bypass
Procedura: 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.
Bariatric Surgery - Sleeve Gastrectomy
This group will undergo a laparoscopic sleeve gastrectomy
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Body Composition
Lasso di tempo: Pre-op, 6 months and 12 months post-op
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Comorbidity resolution
Lasso di tempo: pre-op, 6 months post-op, 12 months post-op
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.
pre-op, 6 months post-op, 12 months post-op
Protein intake and lean tissue mass
Lasso di tempo: Pre-op, 6 months post-op, 12 months post-op
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.
Pre-op, 6 months post-op, 12 months post-op
Exercise and lean tissue mass preservation
Lasso di tempo: Pre-op, 6 months post-op, 12 months post-op
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).
Pre-op, 6 months post-op, 12 months post-op

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Peter Nau

Investigatori

  • Investigatore principale: Peter N Nau, MD, MS, University of Iowa

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2014

Completamento primario (Effettivo)

1 ottobre 2018

Completamento dello studio (Effettivo)

1 ottobre 2018

Date di iscrizione allo studio

Primo inviato

22 maggio 2014

Primo inviato che soddisfa i criteri di controllo qualità

22 maggio 2014

Primo Inserito (Stima)

28 maggio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 novembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 novembre 2018

Ultimo verificato

1 novembre 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 201310819

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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