Effects of Weight Loss Surgery on Bone Health in Adolescents (NCT02557438) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of Weight Loss Surgery on Bone Health in Adolescents
United States240 participantsStarted 2015-06-01
Plain-language 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.
Who can participate
Age range13 Years – 25 Years
SexALL
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Inclusion criteria
✓. Adolescents with morbid obesity 13-25yo 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 post-operative behavioral changes.
Exclusion criteria
✕. Current pregnancy and 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 mos, or if dosage is not stable for \>2 mos
✕
What they're measuring
1
Baseline to 24 months change in total and trabecular volumetric BMD (vBMD) (distal radius and tibia)