We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of an Amino-Acid-Based Blend on Human Growth Hormone (hGH) and Fibromyalgia (FM) Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04510181
Recruitment Status : Unknown
Verified August 2020 by Pekarovics, Susan, MD.
Recruitment status was:  Recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Pekarovics, Susan, MD

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Dietary Supplement: amino acid-based blend Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Amino acid-based blend
The amino acid-based blend will be administered PO daily for the study duration
 Dietary Supplement: amino acid-based blend
blended (listed in descending order) L-lysine, L-arginine, oxo-proline, N-acetyl-l-cysteine, L-glutamine, and Schizonepeta tenuifolia


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in IGF-1 [ Time Frame: 24 weeks, 52 weeks ]
    change from baseline in IGF-1, a surrogate marker of hGH


Secondary Outcome Measures :
  1. Fibromyalgia symptoms [ Time Frame: 24 weeks, 52 weeks ]
    Change from baseline in score on the Revised Fibromyalgia Impact Questionnaire (FIQR, a 21-item self-report measure that estimates the severity and impact of FM. Score ranges from 0-100 with higher scores indicating greater severity/impact of FM)

  2. Stress symptoms [ Time Frame: 24 weeks, 52 weeks ]
    Change from baseline in score of the Perceived Stress Scale (PSS, a 10-item self-report measure that assesses the perception of stress. Total score ranges from 0-40 with higher scores indicating greater perceived stress)

  3. Insulin-like growth factor binding protein-3 (IGFBP-3), an indicator of IGF-1 bioavailability [ Time Frame: 24 weeks, 52 weeks ]
    Change from baseline

  4. body weight (kg) [ Time Frame: 24 weeks, 52 weeks ]
    Change from baseline

  5. body mass index (BMI) [ Time Frame: 24 weeks, 52 weeks ]
    Change from baseline

  6. Blood pressure (systolic and diastolic) [ Time Frame: 24 weeks, 52 weeks ]
    Change from baseline

  7. HbA1c [ Time Frame: 24 weeks, 52 weeks ]
    Change from baseline

  8. Fasting total cholesterol [ Time Frame: 24 weeks, 52 weeks ]
    Change from baseline

  9. Fasting HDL cholesterol [ Time Frame: 24 weeks, 52 weeks ]
    Change from baseline

  10. Fasting LDL cholesterol [ Time Frame: 24 weeks, 52 weeks ]
    Change from baseline

  11. Fasting triglycerides [ Time Frame: 24 weeks, 52 weeks ]
    Change from baseline

  12. Fasting glucose [ Time Frame: 24 weeks, 52 weeks ]
    Change from baseline


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510181


Contacts
Layout table for location contacts
Contact: Kati Kareki 323-951-4916 kati.kereki@gmail.com

Locations
Layout table for location information
United States, California
Private Medical Practics of Susan Pekarovics, MD Recruiting
Los Angeles, California, United States, 90048
Contact: Kati Kareki    323-951-4916    kati.kereki@gmail.com   
Principal Investigator: Susan Pekarovics, MD         
Sponsors and Collaborators
Pekarovics, Susan, MD
Investigators
Layout table for investigator information
Principal Investigator: Susan Pekarovics, MD Pekarovics, Susan, MD
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Pekarovics, Susan, MD
ClinicalTrials.gov Identifier: NCT04510181    
Other Study ID Numbers: SePe-03-2020
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized dataset of selected variables that underlie results in a publication. Some data may not be amenable to complete anonymization and will not be shared to ensure appropriate confidentiality of participant's data.
Supporting Materials: Study Protocol
Time Frame: Beginning 6 months after publication
Access Criteria: Upon appropriate data request by other scientists

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases