Clinical trial NCT04510181: Effect of an Amino-Acid-Based Blend on Human Growth Hormone (hGH) and Fibromyalgia (FM) Symptoms
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Pekarovics, Susan, MD
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Have low to normal levels of hGH (screening IGF-1 levels between the 15th and 50th percentile for age-appropriate levels)
3. Female participants of childbearing potential will agree to avoid pregnancy during the study.
4. Capable of giving signed informed consent

Exclusion Criteria:

1. Human growth hormone deficiency (GHD)
2. 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)
3. Pregnant women or women who wish to become pregnant
4. History of substance abuse
5. Previous treatment with recombinant human growth hormone (rhGH)
6. 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.

Primary outcomes:
measure: Change in IGF-1
timeFrame: 24 weeks, 52 weeks
Secondary outcomes:
measure: Fibromyalgia symptoms
timeFrame: 24 weeks, 52 weeks
measure: Stress symptoms
timeFrame: 24 weeks, 52 weeks
measure: Insulin-like growth factor binding protein-3 (IGFBP-3), an indicator of IGF-1 bioavailability
timeFrame: 24 weeks, 52 weeks
measure: body weight (kg)
timeFrame: 24 weeks, 52 weeks
measure: body mass index (BMI)
timeFrame: 24 weeks, 52 weeks
measure: Blood pressure (systolic and diastolic)
timeFrame: 24 weeks, 52 weeks
measure: HbA1c
timeFrame: 24 weeks, 52 weeks
measure: Fasting total cholesterol
timeFrame: 24 weeks, 52 weeks
measure: Fasting HDL cholesterol
timeFrame: 24 weeks, 52 weeks
measure: Fasting LDL cholesterol
timeFrame: 24 weeks, 52 weeks
measure: Fasting triglycerides
timeFrame: 24 weeks, 52 weeks
measure: Fasting glucose
timeFrame: 24 weeks, 52 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Private Medical Practics of Susan Pekarovics, MD
state: California
Study officials:
affiliation: Pekarovics, Susan, MD
name: Susan Pekarovics, MD
role: PRINCIPAL_INVESTIGATOR
References: