Effect of rhGH Administration on Visceral Adiposity and Markers of Cardiovascular Risk in Obese Adolescent Girls: Phase 2
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months
研究概览
简要总结
Teenagers and adults who are overweight or obese have an increase in fat in the abdomen, which increases their risk for diabetes and heart disease. Reducing abdominal fat is important to reduce risk for diabetes and for heart disease. Overweight teenagers also have low levels of growth hormone compared to normal weight teenagers, and teenagers with the lowest growth hormone levels also have the greatest abdominal fat. In children who are unable to make growth hormone for other reasons, giving back growth hormone leads to a decrease in abdominal fat. We are studying whether giving growth hormone in small doses to overweight teenagers can change body composition. We hypothesize that growth hormone will cause abdominal fat to decrease and reduce the risk markers for diabetes and heart disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adolescent girls 13-21 years old with bone age ≥ 14 years
- •Overweight girls: Body Mass Index (BMI) greater than the 95th percentile for age
- •Waist/Hip ratio ≥ 0.85
- •Insulin Like Growth Factor -1 (IGF-1) below -0.5 standard deviations (SD) for pubertal stage or age
排除标准
- •Pregnancy (positive pregnancy test) prior to enrollment in the study
- •Significant weight gain or loss within 3 months of study (more than 5 kg)
- •Use of medications that affect GH or cortisol levels (such as estrogen including oral contraceptive pills, oral glucocorticoids)
- •Use of medications such as Meridian and Orlistat
- •Presence of diabetes mellitus
- •Uncontrolled Thyroid disorders
- •Chronic renal insufficiency
- •Participation in another simultaneous medical investigation or trial
- •Active neoplasm or history of cancer
- •Prader-Willi syndrome
- •History of scoliosis if bone age is <15 years
- •Hypersensitivity to rhGH or constituents of the injections
研究组 & 干预措施
recombinant human growth hormone
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
干预措施: recombinant human growth hormone (rhGH) (Drug)
Placebo
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months
时间窗: Baseline and 6 months
As a marker of cardiovascular risk, hs-CRP will be assessed at baseline and 6 months to assess the rate at which hs-CRP levels change with rhGH therapy.
Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months
时间窗: Baseline and 6 months
Visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAT) were assessed using single slice MR imaging (MRI)
Changes in Lipid Panel
时间窗: Baseline and 6 months
Lipid profile will be obtained using established methods. Total Cholesterol, Triglycerides, LDL and HDL measurements will be obtained at baseline, and then at the six-month visits to determine the rate at which lipid measures change with rhGH therapy
Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months
时间窗: Baseline and 6 months
Soluble intercellular adhesion molecule-1 (sICAM) was used as a surrogate marker of cardiovascular risk
次要结局
- Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score(Baseline and 6 months)
研究者
Madhusmita Misra
Associate Professor of Pediatrics
Massachusetts General Hospital