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临床试验/NCT00516386
NCT00516386已完成1 期

Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
16
试验地点
1
主要终点
Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa

研究概览

简要总结

The purpose of this study was to determine whether giving insulin like growth factor-I (IGF-I) to adolescent low weight girls is safe and whether this increases levels of bone formation markers.

详细描述

Adolescents with anorexia nervosa (AN) are at high risk for low bone mineral density at a time when healthy adolescents are rapidly accruing bone, with implications for peak bone mass and fracture risk in later life. They are also deficient in insulin-like growth factor I (IGF-I), the bone trophic factor made in the liver in response to growth hormone (GH), despite elevated levels GH. It is possible that deficiency of IGF-I, a hormone very important for the maintenance of skeletal integrity, may contribute to the severe osteopenia seen in AN. The physiologic effects of rhIGF-I treatment in adolescents with AN had not been studied. The goal of this proposal was to investigate the acute effects of rhIGF-I on bone metabolism in adolescent girls with AN.

Specific Aim: It was hypothesized that adolescent AN patients, being IGF-I deficient, would respond to exogenously administered rhIGF-I with elevations in biochemical indices of bone turnover. Therefore, rhIGF-I was administered to AN patients by subcutaneous injection over 10 days with concomitant measurement of indices of bone turnover, and calcium regulatory hormones.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Adolescent girls with anorexia nervosa 12-18 years old

排除标准

  • Pregnancy or nursing
  • Hematocrit < 30%, K < 3 mmol/L
  • Any illness (other than anorexia nervosa) known to affect bone and mineral metabolism such as diabetes, alcoholism, untreated hypo- or hyperthyroidism, or hyperparathyroidism
  • History of use of any medicine, such as corticosteroids, known to affect bone density. Subjects who were on estrogen were still eligible to participate in the study.

研究组 & 干预措施

Insulin like growth factor- 1 (IGF-1)

Experimental

Adolescent girls with AN meeting inclusion criteria were administered recombinant human (rh) rhIGF-1 at a dose of 35-40 mcg/k twice daily by subcutaneous injections for a 7-10 day period.

干预措施: RhIGF-1 (Drug)

结局指标

主要结局

Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa

时间窗: Baseline and 7-10 days

次要结局

  • Change in Levels of N-terminal Propeptide of Type 1 Procollagen (P1NP) Following rhIGF-1 Administration in Girls With Anorexia Nervosa(Baseline and 7-10 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Madhusmita Misra

Associate Professor of Pediatrics

Massachusetts General Hospital

研究点 (1)

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