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

NCT02896452 | Active Not Recruiting

• 1 other identifier: NASA
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovarian Syndrome; Idiopathic Intracranial Hypertension

Outcome Measures

Primary Outcomes (6)

• Single Nucleotide Polymorphism (SNP) Genetic Testing related to 1-Carbon Metabolism Pathway for 523 SNPs

  1 Day

• Ophthalmologic exam -OCT

  Optical coherence tomography test

  1 Day

• Ophthalmologic exam -Fundus

  Fundus photography

  1 Day

• Ophthalmologic exam - US

  Eye ultrasound exam

  1 Day

• Ophthalmologic exam -Vision

  Cycloplegic refraction test

  1 Day

• Ophthalmologic exam -IOP

  Intraocular pressure

  1 Day

Secondary Outcomes (9)

• Questionnaire

  1 Day

• B-vitamin Status - folate

  1 Day

• B-vitamin Status - B12

  1 Day

• B-vitamin Status - serum B12

  1 Day

• Testosterone

  1 Day

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Premenopausal women, age 18-50 years.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Aeronautics and Space Administration: lead
• University of Texas: collaborator
• Mayo Clinic: collaborator
• University of Florida: collaborator
• University of North Carolina: collaborator
• Coastal Eye Associates: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Zwart SR, Gregory JF, Zeisel SH, Gibson CR, Mader TH, Kinchen JM, Ueland PM, Ploutz-Snyder R, Heer MA, Smith SM. Genotype, B-vitamin status, and androgens affect spaceflight-induced ophthalmic changes. FASEB J. 2016 Jan;30(1):141-8. doi: 10.1096/fj.15-278457. Epub 2015 Aug 27.

  PMID: 26316272 BACKGROUND

• Zwart SR, Gibson CR, Mader TH, Ericson K, Ploutz-Snyder R, Heer M, Smith SM. Vision changes after spaceflight are related to alterations in folate- and vitamin B-12-dependent one-carbon metabolism. J Nutr. 2012 Mar;142(3):427-31. doi: 10.3945/jn.111.154245. Epub 2012 Feb 1.

  PMID: 22298570 BACKGROUND

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.

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Pseudotumor Cerebri

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Scott M Smith, PhD

  National Aeronautics and Space Administration (NASA)

  PRINCIPAL INVESTIGATOR

• Alice Y Chang, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: UNKNOWN
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutritionist, Manager for Nutritional Biochemistry

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 12, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2020
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)