Effects of Weight Loss Surgery on Bone Health in Adolescents

NCT02557438 | Active Not Recruiting DMC

• 1 other identifier: 2015P000360
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Surgery

Keywords

Bone; Child Health; Nutrition

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (2)

• Baseline to 24 month change in bone turnover markers (P1NP and CTX)

  2 years

• Baseline to 24 month change in estimated strength measures (FEA of distal radius and tibia)

  2 years

Study Arms (3)

Roux-en-Y Gastric Bypass

Males and females aged 13-25 undergoing Roux-en-Y gastric bypass (RYGB) surgery

Procedure: Roux-en-Y Gastric Bypass

Vertical Sleeve Gastrectomy

Males and females aged 13-25 undergoing vertical sleeve gastrectomy (VSG) surgery

Procedure: Vertical Sleeve Gastrectomy

Non-surgical Obese Controls

Males and females aged 13-25 who are obese and not undergoing weight loss surgery

Interventions

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

Also known as: RYGB

Roux-en-Y Gastric Bypass

Vertical Sleeve Gastrectomy PROCEDURE

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

Also known as: VSG

Vertical Sleeve Gastrectomy

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents and young adults 13-25 years old with obesity undergoing RYGB or VSG and non-surgical controls.

You may qualify if:

• 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.

You may not qualify if:

• 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
• Untreated thyroid dysfunction or on stable dose for \<3 mos
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (8)

• Tuli S, Lopez Lopez AP, Nimmala S, Pedreira CC, Singhal V, Bredella MA, Misra M. Two-Year Study on the Impact of Sleeve Gastrectomy on Depressive and Anxiety Symptoms in Adolescents and Young Adults with Moderate to Severe Obesity. Obes Surg. 2024 Feb;34(2):568-575. doi: 10.1007/s11695-023-07025-z. Epub 2024 Jan 4.

  PMID: 38177554 DERIVED

• Mitchell DM, Singhal V, Nimmala S, Lauze M, Bouxsein ML, Misra M, Bredella MA. Risk of wrist fracture, estimated by the load-to-strength ratio, declines following sleeve gastrectomy in adolescents and young adults. Osteoporos Int. 2024 Feb;35(2):285-291. doi: 10.1007/s00198-023-06941-1. Epub 2023 Oct 21.

  PMID: 37864596 DERIVED

• Kaur S, Nimmala S, Singhal V, Mitchell DM, Pedreira CC, Lauze M, Lee H, Stanford FC, Bouxsein ML, Bredella MA, Misra M. Bone changes post-sleeve gastrectomy in relation to body mass and hormonal changes. Eur J Endocrinol. 2023 Sep 1;189(3):346-354. doi: 10.1093/ejendo/lvad121.

  PMID: 37633255 DERIVED

• Kaur S, Bredella MA, Misra M, Singhal V. Trajectory of Gonadal Hormones in Adolescent Males up to 2 Years After Sleeve Gastrectomy. Obes Surg. 2023 Oct;33(10):3323-3326. doi: 10.1007/s11695-023-06759-0. Epub 2023 Aug 10.

  PMID: 37561269 DERIVED

• Lopez Lopez AP, Tuli S, Lauze M, Becetti I, Pedreira CC, Huber FA, Omeroglu E, Singhal V, Misra M, Bredella MA. Changes in Hepatic Fat Content by CT 1 Year After Sleeve Gastrectomy in Adolescents and Young Adults With Obesity. J Clin Endocrinol Metab. 2023 Nov 17;108(12):e1489-e1495. doi: 10.1210/clinem/dgad390.

  PMID: 37403207 DERIVED

• Huber FA, Singhal V, Tuli S, Becetti I, Lopez Lopez AP, Bouxsein ML, Misra M, Bredella MA. Two-year Skeletal Effects of Sleeve Gastrectomy in Adolescents with Obesity Assessed with Quantitative CT and MR Spectroscopy. Radiology. 2023 Jun;307(5):e223256. doi: 10.1148/radiol.223256.

  PMID: 37310246 DERIVED

• Mitchell DM, Singhal V, Animashaun A, Bose A, Carmine B, Stanford FC, Inge TH, Kelsey MM, Lee H, Bouxsein ML, Yu EW, Bredella MA, Misra M. Skeletal Effects of Sleeve Gastrectomy in Adolescents and Young Adults: A 2-Year Longitudinal Study. J Clin Endocrinol Metab. 2023 Mar 10;108(4):847-857. doi: 10.1210/clinem/dgac634.

  PMID: 36314507 DERIVED

• Nimmala S, Kaur S, Singhal V, Mitchell DM, Stanford FC, Bouxsein ML, Lauze M, Huynh C, Pedreira CC, Lee H, Bredella MA, Misra M. Changes in Sex Steroids and Enteric Peptides After Sleeve Gastrectomy in Youth in Relation to Changes in Bone Parameters. J Clin Endocrinol Metab. 2022 Aug 18;107(9):e3747-e3758. doi: 10.1210/clinem/dgac361.

  PMID: 35689793 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, fecal samples

MeSH Terms

Conditions

Obesity

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Madhu Misra, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Miriam Bredella, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 23, 2015
• Study Start: June 1, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

US (1)