NCT02896452Active, not recruiting
Astronaut Vision Issues in a Ground Analog Population: Polycystic Ovary Syndrome
Astronaut Vision Issues and One Carbon Metabolism: Expanded Polymorphism Evaluation and Evaluation in a Potential Analog Population
Source: ClinicalTrials.gov · Last updated 22 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 60 (actual)
- First submitted
- 24 Aug 2016
- Start date
- 1 Oct 2016
- Primary completion date
- Mar 2020
- Lead sponsor
- National Aeronautics and Space Administration
- Diseases
- High blood pressure
- NCT number
- NCT02896452
What you commit to
- Study type: Observational
- Participants enrolled: 60
- From 1 Oct 2016 to the primary completion date, Mar 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking medications that can affect androgen concentrations or insulin sensitivity.
- Taking medications that affect folate or B12 metabolism, such as methotrexate, trimethoprim, triamterene, phenobarbital, phenytoin, carbamazepine, gabapentin, or primidone or topiramate.
Other illness
- Clinical diagnosis of Cushing's syndrome
- Untreated hypo/hyperthyroidism, elevated prolactin, congenital adrenal hyperplasia, renal insufficiency or diabetes.
Other
- Pregnant, breast-feeding, taking oral contraceptives or currently smoking.
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.