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Effects of Weight Loss Surgery on Bone Health in Adolescents

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ClinicalTrials.gov Identifier: NCT02557438
Recruitment Status : Recruiting
First Posted : September 23, 2015
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Madhusmita Misra, Massachusetts General Hospital

Brief 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.


Condition or disease Intervention/treatment
Obesity Surgery Procedure: Roux-en-Y Gastric Bypass Procedure: Vertical Sleeve Gastrectomy

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bone Metabolism in Adolescents Undergoing Bariatric Surgery
Actual Study Start Date : June 2015
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Roux-en-Y Gastric Bypass
Males and females aged 13-21 undergoing Roux-en-Y gastric bypass (RYGB) surgery
Procedure: Roux-en-Y Gastric Bypass
Determination of the kind of surgery will be made by the participant's providers and not by study staff
Other Name: RYGB

Vertical Sleeve Gastrectomy
Males and females aged 13-21 undergoing vertical sleeve gastrectomy (VSG) surgery
Procedure: Vertical Sleeve Gastrectomy
Determination of the kind of surgery will be made by the participant's providers and not by study staff
Other Name: VSG

Non-surgical Obese Controls
Males and females aged 13-21 who are obese and not undergoing weight loss surgery



Primary Outcome Measures :
  1. Baseline to 24 months change in total and trabecular volumetric BMD (vBMD) (distal radius and tibia) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Baseline to 24 month change in bone turnover markers (P1NP and CTX) [ Time Frame: 2 years ]
  2. Baseline to 24 month change in estimated strength measures (FEA of distal radius and tibia) [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Blood samples, fecal samples


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Obese adolescents and young adults 13-21 years old undergoing RYGB or VSG and non-surgical controls.
Criteria

Inclusion Criteria:

  1. Adolescents with morbid obesity 13-21yo undergoing RYGB (n=36) or VSG (n=36), or being followed without surgical intervention (usual care) (n=48).
  2. Eligibility criteria for weight loss surgery used at the Weight Center include BMI>40 or BMI>35kg/m2 with major comorbidities. A BMI>35 in adolescents reflects a BMI>99th percentile. In order to be considered appropriate surgical candidates, children must have a bone age of ≥14y (F) or ≥16y (M), and ≥1 co-morbidity of obesity. They must have demonstrated efforts at non-surgical weight loss, and consistent compliance with appointments and recommendations. Patients must demonstrate sufficient maturity, psychological stability and cognitive capacity to recognize the significance of the procedure and implement required post-operative behavioral changes.

Exclusion Criteria:

  1. Current pregnancy and breast feeding
  2. Medications other than calcium or vitamin D that affect bone, such as glucocorticoids, phenytoin, phenobarbitone (washout of 3 months prior to enrollment if discontinuation is medically permissible)
  3. Use of antipsychotic medications that cause weight gain if treated for <6 mos, or if dosage is not stable for >2 mos
  4. Untreated thyroid dysfunction or on stable dose for <3 mos
  5. HbA1C>8% (to avoid deleterious effects on bone from uncontrolled T2DM)
  6. Smoking >10 cigarettes/day; substance abuse per Diagnostic and Statistical Manual (DSM) V
  7. Metal implants, intracranial surgical clips or pacemakers
  8. Weight >450 lbs due to limits for MRI and CT.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557438


Contacts
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Contact: Amita Bose, BS 617-724-6046 ABOSE1@MGH.HARVARD.EDU
Contact: Madhu Misra, MD, MPH 617-726-5602 mmisra@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Madhusmita Misra, MD    617-726-3870    mmisra@mgh.harvard.edu   
Contact: Miriam Bredella, MD    617-726-7717    mbredella@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Madhu Misra, MD, MPH Massachusetts General Hospital
Principal Investigator: Miriam Bredella, MD Massachusetts General Hospital
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Responsible Party: Madhusmita Misra, Professor of Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02557438    
Other Study ID Numbers: 2015P000360
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019
Keywords provided by Madhusmita Misra, Massachusetts General Hospital:
Bone
Child Health
Nutrition