The purpose of this study is to examine the effects of weight-loss surgery (specifically Roux-en-Y gastric bypass or Vertical Sleeve Gastrectomy) on bone health in adolescents ages 13-21. It is known that obese adults who undergo weight-loss surgery are at risk for bone loss and decreased bone strength, but the effects of such surgery on bone health in teenagers and young adults is currently unknown. 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.
This is an observational, longitudinal two-year study involving 120 13-21 years olds. Up to 240 subjects will be screened to find these 120 eligible participants. The study began in June 2015 and is estimated to be completed in December 2020.
- Adolescents with morbid obesity 13-21yo undergoing RYGB (n=36) or VSG (n=36), or being followed without surgical intervention (usual care) (n=48).
- 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 postoperative behavioral changes.
- Currently pregnant or breast-feeding
- 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)
- Use of antipsychotic medications that cause weight gain if treated for <6 months, or if dosage is not stable for >2 months
- Untreated thyroid dysfunction or on stable dose for <3 months
- HbA1C>8% (to avoid deleterious effects on bone from uncontrolled T2DM)
- Smoking >10 cigarettes/day; substance abuse per Diagnostic and Statistical Manual (DSM) V
- Metal implants, intracranial surgical clips or pacemakers
- Weight >450 lbs due to limits for MRI and CT.
This study is taking place in Massachusetts General Hospital, Boston, Massachusetts, United States, 02114. For further information, please contact Amita Bose, BS on 617-724-6046 or at ABOSE1@MGH.HARVARD.EDU. You may also contact Madhu Misra, MD, MPH on 617-726-5602 or at email@example.com.
Sponsors / Collaborators
This study is sponsored by Massachusetts General Hospital. The Principal Investigators are Madhu Misra, MD, MPH and Miriam Bredella, MD.
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