Clinical trial

Effects of Weight Loss Surgery on Bone Health in Adolescents

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT02557438

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age13 Years to 25 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Surgery

Full registry criteria

Inclusion Criteria: 1. Adolescents with morbid obesity 13-25yo 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.

Treatments and study arms

Roux-en-Y Gastric Bypass

Procedure

Determination of the kind of surgery will be made by the participant's providers and not by study staff

Vertical Sleeve Gastrectomy

Procedure

Determination of the kind of surgery will be made by the participant's providers and not by study staff

Primary outcomes

Baseline to 24 months change in total and trabecular volumetric BMD (vBMD) (distal radius and tibia)2 years

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Massachusetts General Hospital🇺🇸 Boston, Massachusetts, United States