Effect of an Orally Administered Amino Acid-Based Blend on Human Growth Hormone (hGH) Levels and Fibromyalgia (FM) Symptoms: A Prospective, Open-Label, Single-Arm, Observational 24-Week Study in Adults With Poorly Controlled FM and Low hGH
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in IGF-1
研究概览
简要总结
The purpose of the study is to investigate the effect of the amino acid-based blend on growth hormone levels (measured by IGF-1) and clinical symptoms in individuals with treatment-resistant FM and low-normal hGH.
详细描述
Low hGH levels have been observed in approximately 1/3 of individuals with FM. Low hGH levels are hypothesized to contribute to inadequate treatment outcomes in many individuals with FM and several studies have demonstrated symptom improvement in individuals with FM and low hGH who received rhGH therapy. The amino acid-based blend represents a novel mechanism for increasing endogenous hGH production. It has been shown to produce an increase in endogenous hGH levels in healthy individuals by attenuating the inhibitory effect of somatostatin on hGH release. The amino acid-based blend may be a safe and effective treatment for FM in individuals with poorly controlled FM and low-normal hGH.
This study will investigate the effect of taking the amino acid blend on IGF-1 levels (a surrogate marker of the body's growth hormone levels), fibromyalgia symptoms, stress symptoms, body weight, and other cardiometabolic biomarkers in individuals with treatment-resistant FM and low-normal hGH.
After being informed about the study and potential risks, all eligible participants giving written informed consent will administer the amino acid-based blend daily. Standard care for fibromyalgia will continue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a clinical diagnosis of FM for at least 10 years, poorly controlled FM symptom, and receiving standard of care treatment at the Private Medical Practice of Susan Pekarovics, MD
- •Have low to normal levels of hGH (screening IGF-1 levels between the 15th and 50th percentile for age-appropriate levels)
- •Female participants of childbearing potential will agree to avoid pregnancy during the study.
- •Capable of giving signed informed consent
排除标准
- •Human growth hormone deficiency (GHD)
- •Individuals with a total score of ≥15 (indicating the presence of moderately severe major depression) or a score of >0 on Item 9 (suicidal ideation) on the Patient Health Questionnaire-9 (PHQ-9)
- •Pregnant women or women who wish to become pregnant
- •History of substance abuse
- •Previous treatment with recombinant human growth hormone (rhGH)
- •Individuals belonging to the following vulnerable populations: people with disabilities, people who cannot read, educationally disadvantaged, individuals with a serious or life threatening illness, prisoners, non-English speakers, economically disadvantaged individuals, employees of the study sponsor/site.
结局指标
主要结局
Change in IGF-1
时间窗: 24 weeks, 52 weeks
change from baseline in IGF-1, a surrogate marker of hGH
次要结局
- Stress symptoms(24 weeks, 52 weeks)
- Fibromyalgia symptoms(24 weeks, 52 weeks)
- Insulin-like growth factor binding protein-3 (IGFBP-3), an indicator of IGF-1 bioavailability(24 weeks, 52 weeks)
- body mass index (BMI)(24 weeks, 52 weeks)
- HbA1c(24 weeks, 52 weeks)
- Fasting total cholesterol(24 weeks, 52 weeks)
- Fasting HDL cholesterol(24 weeks, 52 weeks)
- Fasting glucose(24 weeks, 52 weeks)
- Blood pressure (systolic and diastolic)(24 weeks, 52 weeks)
- Fasting triglycerides(24 weeks, 52 weeks)
- body weight (kg)(24 weeks, 52 weeks)
- Fasting LDL cholesterol(24 weeks, 52 weeks)