Plant Exosomes and Patients Diagnosed With Polycystic Ovary Syndrome (PCOS) 17
- Conditions
- Polycystic Ovary Syndrome
- Interventions
- Other: Aloe exosomesOther: Ginger exosomesOther: Placebo
- Registration Number
- NCT03493984
- Lead Sponsor
- University of Louisville
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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
-
• 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aloe exosomes Aloe exosomes - Ginger and aloe exosomes Aloe exosomes - Ginger exosomes Ginger exosomes - Ginger and aloe exosomes Ginger exosomes - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change in glucose tolerance as measured by a glucose tolerance test 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
Name Time Method Inflammatory marker Foxp3 Baseline, twelve weeks Foxp3
Inflammatory marker interleukin 10 (IL-10) Baseline, twelve weeks IL-10
Inflammatory marker interleukin 1b (IL-1b) Baseline, twelve weeks IL-1b
Change in serum insulin levels during a glucose tolerance test 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
Stool sample Baseline, twelve weeks Gut microbiota
Inflammatory marker cluster of differentiation 4 (CD4) Baseline, twelve weeks CD4
Inflammatory marker cluster of differentiation 11b (CD11b) Baseline, twelve weeks CD11b
Inflammatory marker F4/80 Baseline, twelve weeks F4/80
Inflammatory marker cluster of differentiation 33 (CD33) Baseline, twelve weeks CD33
Inflammatory marker tumor necrosis factor alpha (TNF-a) Baseline, twelve weeks TNF-a
Sex hormone binding globulin Baseline, twelve weeks Changes in sex hormone binding globulin in nmol/L
Inflammatory marker cluster of differentiation 8 (CD8) Baseline, twelve weeks CD8
Inflammatory marker interleukin 6 (IL-6) Baseline, twelve weeks IL-6
Serum Testosterone Baseline, twelve weeks Serum testosterone in ng/dL Changes in serum testosterone as measured in ng/dL
Trial Locations
- Locations (1)
University of Louisville
🇺🇸Louisville, Kentucky, United States