测试版
试验雷达 AI
一个试验符合筛选条件
卡片视图
返回搜索

Bone Metabolism in 12-21 Year Olds Undergoing GLP-1 Receptor Agonist Therapy 120 生活方式 饮食

招募中
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT06903923是一项针对Obesity in Children，Bone Strength，GLP - 1，生活方式调整，骨密度，肥胖症的观察研究试验，目前试验状态为招募中。试验始于2025年7月31日，计划招募120名患者。该研究由弗吉尼亚大学主导，预计于2030年4月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月31日。
简要概括

The goal of this clinical trial is to compare bone health markers over 24 months in participants 12 - 21 years of age with obesity who are starting the glucagon-like peptide-1 receptor agonists (GLP-1RAs) as compared to those with similar weight followed by lifestyle management.

Participants will:

  • Take GLP-1RA as prescribed or continue to work on lifestyle management for weight loss
  • Take provided calcium and vi...
显示更多
详细描述
Obesity is now epidemic, and as a consequence, the use of weight loss medications and surgery to manage obesity is increasing. Weight loss surgery is associated with significant bone loss, concerning during the adolescent years of peak bone accrual. With the increasing use of weight loss medications, particularly glucagon-like-peptide 1 receptor agonists (GLP-1 RAs), in adolescents, it is essential to determine wheth...显示更多
官方标题

Bone Metabolism in Adolescents Undergoing GLP-1 Receptor Agonist Therapy

疾病
Obesity in ChildrenBone StrengthGLP - 1生活方式调整骨密度肥胖症
其他研究标识符
NCT编号
NCT06903923
实际开始日期
2025-07-31
最近更新发布
2026-03-31
预计完成日期
2030-04-30
计划入组人数
120
研究类型
观察研究
试验状态
招募中
关键词
obesity
obesity in children
bone strength
GLP-1
Lifestyle modification
bone density
semaglutide
liraglutide
试验组/干预措施
参与者组/试验组干预措施/治疗方法
GLP-1 receptor agonist (RA) + Calcium & Vitamin D
The GLP-1 RA, will be prescribed by the participants' physician for routine clinical care for the management of obesity while the Calcium + Vitamin D will be provided by the research investigator.
GLP-1 receptor agonist
Participants prescribed a GLP-1 receptor agonist by their physician will be enrolled in this arm of the study. All participants will receive study provided calcium \& vitamin D supplement to support bone health and to reduce this as a confounding factor in overall outcomes
Lifestyle Management + Calcium & Vitamin D
The Lifestyle Management will be overseen by the participants' physician for routine clinical care for the management of obesity while Calcium + Vitamin D will be provided by the research investigator.
生活方式管理
Participants receiving usual lifestyle interventions will be enrolled in this arm of the study. All participants will receive study provided calcium \& vitamin D supplement to support bone health and to reduce this as a confounding factor in overall outcomes
主要终点
结果指标度量标准描述时间框架
Change in total volumetric bone mineral density (vBMD) the distal radius measured by HR-pQCT
To assess the effect of GLP-1 RA therapy on vBMD at a non-weight-bearing site (distal radius) in adolescents and young adults with obesity, compared to matched controls receiving lifestyle management.
24 months
次要终点
结果指标度量标准描述时间框架
Change in total volumetric bone mineral density (vBMD) the distal tibia measured by HR-pQCT
24 months
Change in trabecular vBMD of the distal tibia and radius assessed by HR-pQCT
24 months
Change in areal BMD of the lumbar spine and total hip measured by DXA
24 months
Change in estimated bone strength (radius and tibia) using micro finite element analysis (μFEA)
24 months
Change in load-to-strength ratio at the radius and hip
24 months
Change in bone turnover markers (P1NP and CTX)
To assess whether preservation of skeletal integrity is associated with changes in bone formation and resorption markers (P1NP and CTX)
24 months
Change in hormones
Change in hormones known to impact bone (insulin, ghrelin, PYY, oxytocin, estrogens and sclerostin).
24 months
参与助手
资格标准

适龄参与研究
儿童, 成人
最低年龄要求
12 Years
适龄性别
全部
  • • Adolescents and young adults with obesity 12-21 years old starting GLP-1 RA therapy (except for dulaglutide or exenatide) or followed with 'usual' care.
  • Diagnosis of obesity (BMI ≥ 95th percentile for age and sex). The FDA has approved the use of GLP-1 RAs (liraglutide and semaglutide) for adolescents ≥ 12 years old with BMI ≥ 95th percentile for age and sex, and tirzepatide for adults with obesity. Those in the GLP-1 RA arm must have demonstrated efforts at weight loss with 'usual' care, and consistent compliance with appointments and recommendations.
  • Participants must demonstrate sufficient maturity, psychological stability and cognitive capacity to recognize the significance of being on medical therapy and implement required behavioral changes
  • Patients taking orlistat as a precursor to GLP-1 RA therapy due to insurance requirements may be included given minimal effects on weight.
  • Use of the following contraceptive methods is permitted: Combine oral contraceptives (COCs); continuous oral progestin; Progestin-releasing intrauterine device (IUD); Progestin implant; transdermal patch.
  • Patients with celiac disease will be included if the condition is well controlled and they are on a gluten free diet with normal 25(OH)D levels confirmed by clinical labs within 3 months of enrollment in the study. If a patient does not have recent 25(OH)D results, we will add this to the screening labs.

  • • Current or previous history of pregnancy and breast feeding.
  • Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 if in the GLP-1 RA group.
  • > 5 kg weight loss over 3 months given the known impact of significant weight loss on bone density.
  • Use of dulaglutide and exenatide (of the GLP-1 RAs) given minimal weight loss with these drugs.
  • Use of medications such as metformin, phentermine, or topiramate that may cause weight loss, or obesogenic antipsychotic medications if treated for <3 months, or if dosage is not stable for >2 months.
  • Medications other than calcium or vitamin D that affect bone, such as systemic glucocorticoids, phenytoin, phenobarbitone (unless there is a washout period of 3 months prior to enrollment if discontinuation is medically permissible)
  • Female participants on hormonal contraception will be excluded if this involves use of depot medroxyprogesterone acetate (DMPA). DMPA has profound deleterious effect on bone density, which could confound study outcomes related to bone health. Rationale: DMPA has a well-documented deleterious effect on bone density, which could confound study outcomes related to bone health or metabolic parameters.
  • Untreated thyroid dysfunction or on stable dose for <3 months. Primary thyroid dysfunction will be defined as: a TSH ≥ 10 IU/L or low per given reference range with unknown thyroid antibody status, or an abnormal TSH if known positive antibodies. Patients with known hypothyroidism will be included if appropriately treated with levothyroxine and have a normal TSH. For patients with secondary hypothyroidism (deficient production of TSH from the pituitary gland causing hypothyroidism), normal free T4 concentrations (and not TSH alterations) will be used for study inclusion, and recent adjustments in the levothyroxine dose will be permissible as long as free T4 concentrations are in the normal range at dose adjustment (as dose adjustments are often made to get free T4 concentrations in the upper half of the normal range when assessed levels are in the lower half of the normal range). Patients with hyperthyroidism will be excluded given known deleterious effects on both weight and bone metabolism.
  • Medical conditions known to impact weight or bone density, such as chronic gastrointestinal disorders (including inflammatory bowel disease), other inflammatory conditions, such as rheumatoid arthritis or ankylosing spondylitis, untreated thyroid disease, and hypercortisolemia.
  • HbA1C >8% (to avoid deleterious effects on bone from uncontrolled T2DM).
  • Smoking >10 cigarettes/day given deleterious effects on bone; substance abuse per DSM-5.
  • Weight >450 lbs due to limits for DXA scanners.
  • History of metabolic and bariatric surgery.
  • Judged by the investigators to be inappropriate for the study for other reasons not detailed above.
University of Virginia logo弗吉尼亚大学294 个活跃的临床试验可供探索
National Institutes of Health (NIH) logoNational Institutes of Health (NIH)
研究责任方
Madhusmita Misra, 主要研究者, Professor of Pediatrics, University of Virginia
研究中心联系人
联系人: Madhusmita Misra, MD, MPH, 434-924-9141, [email protected]
联系人: Christine Burt Solorzano, MD, 434-924-9084, [email protected]
1 位于 1 个国家/地区的研究中心

Virginia

University of Virginia Medical Center, Charlottesville, Virginia, 22903, United States
Melissa G Gilrain, BS, 联系人, 434-243-6911, [email protected]
联系人, [email protected]
Madhusmita Misra, MD, MPH, 主要研究者
Christine Burt Solorzano, MD, 分研究者
招募中