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NCT02148068 · ClinicalTrials.gov registry record
Changes in Body Composition Following Bariatric Surgery
A clinical trial of Obesity, sponsored by Peter Nau.
- Completed
- Registry status
- 136
- Enrollment target
- 1
- Study location
NCT02148068: Completed study of Obesity, sponsored by Peter Nau.
NCT02148068 is a study of Obesity that has completed, run by Peter Nau. The registered enrollment target is 136 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02148068, a study of Obesity, has completed, sponsored by Peter Nau.
- COMPLETED
- Registry status
- 136 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Bariatric Surgery
Study Locations (1)
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2014-05 |
| Est. Completion | 2018-10 |
What the finished NCT02148068 record still lists
NCT02148068 is an observational study that tracks outcomes without assigning an intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Bariatric Surgery is the first listed.
NCT02148068 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT02148068 about?
NCT02148068 is a clinical study titled "Changes in Body Composition Following Bariatric Surgery". 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 appr...
What is the current status of trial NCT02148068?
This trial is currently completed. The enrollment target is 136 participants. The study started on 2014-05. Estimated completion is 2018-10.
What conditions does trial NCT02148068 study?
This clinical trial studies the following conditions: Obesity.
What interventions are being tested in trial NCT02148068?
The interventions under investigation include: Bariatric Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT02148068?
This trial is sponsored by Peter Nau, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02148068 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02148068's enrollment target sits among peer trials
136 407th of 1053 higher than 641 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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