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Trial record 16 of 37 for:    idiopathic intracranial hypertension

Astronaut Vision Issues in a Ground Analog Population: Polycystic Ovary Syndrome (PCOS)

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ClinicalTrials.gov Identifier: NCT02896452
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : October 8, 2018
Sponsor:
Collaborators:
University of Texas
Mayo Clinic
University of Florida
University of North Carolina
Coastal Eye Associates
Information provided by (Responsible Party):
Scott M. Smith, National Aeronautics and Space Administration (NASA)

Brief Summary:
The investigators have documented a genetic predisposition for some astronauts to develop ophthalmologic issues (e.g., choroidal folds, cotton wool spots, optic disc edema). Women with polycystic ovary syndrome (PCOS) have several characteristics similar to those described in astronauts, including: higher homocysteine concentrations, increased incidence of intracranial hypertension, increased retinal nerve fiber layer thickness, increased incidence of white matter hyperintensities on MRI, increased androgen concentrations (or androgen responses to space flight), and indices of altered carbohydrate metabolism. Women with PCOS have not been evaluated in detail regarding the occurrence of other anomalies observed in astronauts including choroidal folds, optic disc edema and cotton wool spots as well as changes in cycloplegic refraction, and optic nerve sheath diameter. While researchers have evaluated one-carbon metabolism pathway polymorphisms re: PCOS, and initial studies show an association with certain one-carbon polymorphisms, none have looked at the complete set of SNPs proposed here. This study will evaluate women with PCOS and/or idiopathic intracranial hypertension (IIH) to assess one-carbon biochemistry and genetics and their possible correlation with ophthalmologic findings. The investigators aim to clarify the relationship of one carbon metabolism and ophthalmic findings in astronauts and patients with PCOS and/or IIH.

Condition or disease
Polycystic Ovarian Syndrome Idiopathic Intracranial Hypertension

Detailed Description:

Evidence from initial analysis of 5 SNPs in the one-carbon metabolism pathway suggests that one-carbon pathway genes may predict risk of ocular changes and possible vision impairment during and after long-duration space flight. It is not precisely known whether it is these particular genes, or a haplotype of genes that are linked to these genes, that influence risk. Furthermore, ancestry is a strong factor that predicts SNP occurrence in a population, and the association between one-carbon metabolism and the risk of vision-related issues may simply stem from the fact that one particular ancestry has a higher prevalence of these SNPs.

The investigators propose that there are other SNPs in the one-carbon metabolism pathway that alter risk of ocular changes and potential vision impairment during long-duration spaceflight. To that end, extended studies of one-carbon genetics in astronauts have recently been initiated. The investigators hypothesize that the differences between genetic, biochemical, and ophthalmologic findings in PCOS and/or IIH patients and controls will mirror many of the differences found between astronauts who had ophthalmic issues during and after flight.

SPECIFIC AIMS

The key aims of this study are to: a) determine extensive one carbon pathway and related biochemistry, targeted metabolomics, and genetics (523 SNPs of the 85 major genes), and b) conduct ophthalmologic exams on patients in one of four treatment groups:

  1. women diagnosed with PCOS without IIH
  2. women diagnosed with PCOS and IIH
  3. women diagnosed with IIH without PCOS
  4. women without PCOS or IIH Participants will be matched by age and body mass index (BMI). Statistical analyses will be used to evaluate the independent and shared contributions of age, body mass (BMI), and genetics on biochemical, and ophthalmologic outcomes, with False Discovery Rate adjustments to account for multiple comparisons.

A secondary aim is to combine the patient and control data from this study with ISS crewmember data in order to help inform us on whether or not these two cohorts (astronauts with ophthalmic issues, PCOS patients) share similar associations among one-carbon metabolism genetics and biochemistry and ophthalmologic data identified in the investigators' earlier analyses.


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Astronaut Vision Issues and One Carbon Metabolism: Expanded Polymorphism Evaluation and Evaluation in a Potential Analog Population
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : August 2020


Group/Cohort
Women diagnosed with PCOS without IIH
Women diagnosed with polycystic ovary syndrome without idiopathic intracranial hypertension
Women diagnosed with PCOS and IIH
Women diagnosed with polycystic ovary syndrome and idiopathic intracranial hypertension
Women diagnosed with IIH without PCOS
Women diagnosed with idiopathic intracranial hypertension without polycystic ovary syndrome
Women without PCOS or IIH
Women age and body mass index match controls without polycystic ovary syndrome or intracranial hypertension



Primary Outcome Measures :
  1. Single Nucleotide Polymorphism (SNP) Genetic Testing related to 1-Carbon Metabolism Pathway for 523 SNPs [ Time Frame: 1 Day ]
  2. Ophthalmologic exam -OCT [ Time Frame: 1 Day ]
    Optical coherence tomography test

  3. Ophthalmologic exam -Fundus [ Time Frame: 1 Day ]
    Fundus photography

  4. Ophthalmologic exam - US [ Time Frame: 1 Day ]
    Eye ultrasound exam

  5. Ophthalmologic exam -Vision [ Time Frame: 1 Day ]
    Cycloplegic refraction test

  6. Ophthalmologic exam -IOP [ Time Frame: 1 Day ]
    Intraocular pressure


Secondary Outcome Measures :
  1. Questionnaire [ Time Frame: 1 Day ]
    Questions related to birthplace, as well as birthplace of parents and grandparents, if known

  2. B-vitamin Status - folate [ Time Frame: 1 Day ]
    Serum Folate measurement

  3. B-vitamin Status - B12 [ Time Frame: 1 Day ]
    Methylmalonic acid

  4. B-vitamin Status - serum B12 [ Time Frame: 1 Day ]
    Serum vitamin B-12

  5. Testosterone [ Time Frame: 1 Day ]
  6. Hemoglobin [ Time Frame: 1 Day ]
  7. Plasminogen Activator Inhibitor Antigen [ Time Frame: 1 Day ]
  8. Insulin [ Time Frame: 1 Day ]
  9. Homocysteine [ Time Frame: 1 Day ]

Biospecimen Retention:   Samples Without DNA
The Mayo Clinic/NASA would like to keep the samples for future research. The subjects can still take part in the current study even if they don't want their sample to be used for future research. If the subject agrees to give their sample it will become the property of NASA. Some future studies may examine the DNA. The PI would contact the subject if there are findings which would be useful for the subjects' health care. The subject would be given general information on the potential risks, benefits, and costs of choosing to learn about the findings.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Premenopausal women, age 18-50 years.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of PCOS and/or IIH
  • No current medications for the treatment of PCOS
  • Age and BMI-matched healthy women without PCOS or IIH will be used as controls

Exclusion Criteria:

  • Clinical diagnosis of Cushing's syndrome
  • Untreated hypo/hyperthyroidism, elevated prolactin, congenital adrenal hyperplasia, renal insufficiency or diabetes.
  • Currently taking medications that can affect androgen concentrations or insulin sensitivity.
  • Pregnant, breast-feeding, taking oral contraceptives or currently smoking.
  • Taking medications that affect folate or B12 metabolism, such as methotrexate, trimethoprim, triamterene, phenobarbital, phenytoin, carbamazepine, gabapentin, or primidone or topiramate.

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): NCT02896452


Contacts
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Contact: Chelsie VanOort 507-266-3912 VanOort.Chelsie@mayo.edu
Contact: Sara R Zwart, PhD 281-483-3753 sara.zwart-1@nasa.gov

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Chelsie Van Oort    507-266-3912    VanOort.Chelsie@mayo.edu   
Principal Investigator: Alice Y Chang, MD         
Sponsors and Collaborators
National Aeronautics and Space Administration (NASA)
University of Texas
Mayo Clinic
University of Florida
University of North Carolina
Coastal Eye Associates
Investigators
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Principal Investigator: Scott M Smith, PhD National Aeronautics and Space Administration (NASA)
Principal Investigator: Alice Y Chang, MD Mayo Clinic

Publications:
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Responsible Party: Scott M. Smith, Nutritionist, Manager for Nutritional Biochemistry, National Aeronautics and Space Administration (NASA)
ClinicalTrials.gov Identifier: NCT02896452     History of Changes
Other Study ID Numbers: NASA
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be provided upon subject request.

Additional relevant MeSH terms:
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Intracranial Hypertension
Pseudotumor Cerebri
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases