Clinical trial NCT03493984: Plant Exosomes and Patients Diagnosed With Polycystic Ovary Syndrome (PCOS) 17
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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change in glucose tolerance as measured by a glucose tolerance test
timeFrame: Baseline, twelve weeks.
Secondary outcomes:
measure: Change in serum insulin levels during a glucose tolerance test
timeFrame: Baseline, twelve weeks
measure: Serum Testosterone
timeFrame: Baseline, twelve weeks
measure: Sex hormone binding globulin
timeFrame: Baseline, twelve weeks
measure: Stool sample
timeFrame: Baseline, twelve weeks
measure: Inflammatory marker cluster of differentiation 4 (CD4)
timeFrame: Baseline, twelve weeks
measure: Inflammatory marker cluster of differentiation 8 (CD8)
timeFrame: Baseline, twelve weeks
measure: Inflammatory marker Foxp3
timeFrame: Baseline, twelve weeks
measure: Inflammatory marker cluster of differentiation 11b (CD11b)
timeFrame: Baseline, twelve weeks
measure: Inflammatory marker cluster of differentiation 33 (CD33)
timeFrame: Baseline, twelve weeks
measure: Inflammatory marker F4/80
timeFrame: Baseline, twelve weeks
measure: Inflammatory marker interleukin 10 (IL-10)
timeFrame: Baseline, twelve weeks
measure: Inflammatory marker interleukin 1b (IL-1b)
timeFrame: Baseline, twelve weeks
measure: Inflammatory marker tumor necrosis factor alpha (TNF-a)
timeFrame: Baseline, twelve weeks
measure: Inflammatory marker interleukin 6 (IL-6)
timeFrame: Baseline, twelve weeks
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Henry Bohler, MD
role: PRINCIPAL_INVESTIGATOR
References: