Obesity Clinical Trial - Effects of Weight Loss Surgery on Bone Health in

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to examine the impact of weight-loss surgery (Roux-en-Y gastric bypass or Vertical Sleeve Gastrectomy) on bone outcomes in girls and boys ages 13-21. This study will also examine a group of overweight boys and girls who are not scheduled or planned for surgery for comparison of these outcomes. Obese adults who undergo weight-loss surgery are at risk for bone loss and decreased bone strength. The investigators do not know the effects of such surgery on bone in teenagers and young adults. The purpose of this study is to find out how different types of weight loss surgery affect bone density and strength in teenagers and young adults and compare these results to obese teenagers and young adults who are not undergoing weight-loss surgery.

Clinical Trial Description

Our overall hypothesis is that both Roux-en-Y Gastric Bypass (RYGB) and vertical sleeve gastrectomy (VSG) in adolescents with morbid obesity will lead to a reduction in areal and volumetric BMD, and deterioration in bone structure and estimated bone strength, and an increase in marrow adiposity. We further hypothesize that these effects will be due in part to a decrease in lean mass, changes in enteric peptide hormones and reduced estrogen levels. We will enroll 120 participants 13-21 years old for this two-year longitudinal study (36 in each of the surgical groups and 48 non-surgical controls with obesity). We will screen up to 240 subjects to find these 120 eligibile subjects. Areal bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry (DXA), volumetric BMD by quantitative computed tomography (QCT), bone structure and strength using high resolution peripheral QCT and finite element analysis, and marrow fat using magnetic resonance spectroscopy. Body composition will also be assessed. Adolescence is a critical time for bone accrual and the use of bariatric procedures is increasing in teenagers. This study will provide novel data needed to establish effects of RYGB vs. VSG on bone in adolescents and will begin to delineate underlying mechanisms. Clarifying these mechanisms will identify therapeutic targets to optimize bone accrual in adolescents undergoing bariatric surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02557438
Study type	Observational
Source	Massachusetts General Hospital
Contact
Status	Active, not recruiting
Phase
Start date	June 1, 2015
Completion date	March 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effects of Weight Loss Surgery on Bone Health in Adolescents

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms