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Plant Exosomes and Patients Diagnosed With Polycystic Ovary Syndrome (PCOS) 17

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03493984
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Henry Bohler, University of Louisville

Study Description
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Brief Summary:
The purpose of this study is to see if substances contained in ginger or aloe plants, called exosomes, will treat and improve the condition polycystic ovary syndrome

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Other: Ginger exosomes Other: Aloe exosomes Other: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Preliminary Clinical Trial Investigating the Ability of Plant Exosomes to Mitigate Insulin Resistance and Chronic Inflammation in Patients Diagnosed With Polycystic Ovary Syndrome (PCOS)
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Ginger exosomes Other: Ginger exosomes
Naturally occurring plant exosomes from ginger
Experimental: Aloe exosomes Other: Aloe exosomes
Naturally occurring plant exosomes from aloe
Experimental: Ginger and aloe exosomes Other: Ginger exosomes
Naturally occurring plant exosomes from ginger

Other: Aloe exosomes
Naturally occurring plant exosomes from aloe
Placebo Comparator: Placebo Other: Placebo
Exosome placebo tablet


Outcome Measures
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Primary Outcome Measures :
  1. Change in glucose tolerance as measured by a glucose tolerance test [ Time Frame: Baseline, twelve weeks. ]
    A glucose challenge test will be administered after initially obtaining a fasting serum glucose(baseline), then administering a 75 gram glucose load orally, then a serum glucose will be obtained 2 hours later. Serum glucose is measured in mg/dL.


Secondary Outcome Measures :
  1. Change in serum insulin levels during a glucose tolerance test [ Time Frame: Baseline, twelve weeks ]
    Serum insulin levels in multi-international units per litre (mIU/L) will be measured at baseline and after 2 hours during a 2-hour glucose tolerance test

  2. Serum Testosterone [ Time Frame: Baseline, twelve weeks ]
    Serum testosterone in ng/dL Changes in serum testosterone as measured in ng/dL

  3. Sex hormone binding globulin [ Time Frame: Baseline, twelve weeks ]
    Changes in sex hormone binding globulin in nmol/L

  4. Stool sample [ Time Frame: Baseline, twelve weeks ]
    Gut microbiota

  5. Inflammatory marker cluster of differentiation 4 (CD4) [ Time Frame: Baseline, twelve weeks ]
    CD4

  6. Inflammatory marker cluster of differentiation 8 (CD8) [ Time Frame: Baseline, twelve weeks ]
    CD8

  7. Inflammatory marker Foxp3 [ Time Frame: Baseline, twelve weeks ]
    Foxp3

  8. Inflammatory marker cluster of differentiation 11b (CD11b) [ Time Frame: Baseline, twelve weeks ]
    CD11b

  9. Inflammatory marker cluster of differentiation 33 (CD33) [ Time Frame: Baseline, twelve weeks ]
    CD33

  10. Inflammatory marker F4/80 [ Time Frame: Baseline, twelve weeks ]
    F4/80

  11. Inflammatory marker interleukin 10 (IL-10) [ Time Frame: Baseline, twelve weeks ]
    IL-10

  12. Inflammatory marker interleukin 1b (IL-1b) [ Time Frame: Baseline, twelve weeks ]
    IL-1b

  13. Inflammatory marker tumor necrosis factor alpha (TNF-a) [ Time Frame: Baseline, twelve weeks ]
    TNF-a

  14. Inflammatory marker interleukin 6 (IL-6) [ Time Frame: Baseline, twelve weeks ]
    IL-6


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-40 year
  • Patients must have a confirmed diagnosis of PCOS according to the Rotterdam Criteria. At least 2 of the following 3 characteristics must be present: 1. Oligo-anovulation 2. Clinical and/or biochemical signs of androgen excess and 3. Polycystic ovarian morphology (PCOM) (defined by an increased number of small antral follicles [≥12 follicles that were <10 mm in diameter] or an increased individual ovarian volume [>10 cm3] in 1 or both ovaries. Disorders mimicking PCOS must also be excluded, including thyroid dysfunction, hyperprolactinemia, late-onset congenital adrenal hyperplasia, and ovarian or adrenal androgen-producing tumors.
  • Of all subjects screened patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines.
  • Ability to understand and willingness to sign a written informed consent document.
  • Absence of life limiting medical conditions

Exclusion Criteria:

  • • Pregnancy

    • Known HIV
    • Patients receiving immunosuppressive drugs
    • Patients taking confounding medications such as sex steroids, infertility medications or insulin sensitizers or any medication deemed to alter glucose and/or insulin levels
    • Active malignancy in the last 5 years
    • Patients receiving any other investigational agent(s)
    • Ginger and/or aloe allergy
Contacts and Locations
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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): NCT03493984


Contacts
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Contact: Henry Bohler, MD 502-588-7660 hcbohl01@exchange.louisville.edu
Contact: Huange-Ge Zhang, Ph.D. 502-852-8623 h0zhan17@louisville.edu

Locations
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United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Henry Bohler, M.D.    502-727-9384    h.bohler@louisville.edu   
Contact: Huang-Ge Zhang, Ph.D.    502-852-8623    h0zhan17@louisville.edu   
Sponsors and Collaborators
University of Louisville
Investigators
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Principal Investigator: Henry Bohler, MD University of Louisville
More Information
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Responsible Party: Henry Bohler, Associate Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT03493984    
Other Study ID Numbers: 17.1114
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
 Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases