Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444288
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2007-03-06
Brief Title:
PCOS Twin Study - Environmental Factors in the Development of Polycystic Ovary Syndrome Phase 2
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
PCOS Twin Study - Environmental Factors in the Development of Polycystic Ovary Syndrome Phase 2
Status:
COMPLETED
Status Verified Date:
2010-03-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Polycystic Ovary Syndrome or PCOS is the most common endocrine disorder in women Depending on the strictness of the diagnostic criteria used it is thought to occur in about 6-10 of all women many of whom do not know they have the syndrome Women with PCOS produce abnormally high levels of male hormones hyperandrogenism this counteracts their ovaries ability to make enough of the female hormones estrogen and progesterone needed for normal menstruation PCOS is the number one cause of hormonally related infertility and also increases womens risks for diabetes high blood pressure hypercholesteremia cardiovascular disease and certain cancers It is currently unclear to what extent PCOS and PCOS-associated traits hyperandrogenisms hyperinsulinemia insulin resistance type 2 diabetes dyslipidemia hypertension obesity and coronary artery disease are the results of environmental factors or genetic predisposition Therefore the NIEHS Program in Clinical Research is conducting a multi-phase twin study to measure the extent of PCOS heritability and to identify environmental and genetic factors involved in the development of PCOS The proposal described here is for Phase 2 of this study The goals of Phase 2 are to 1 establish more reliable concordance rates and baseline heritability estimates for PCOS in MZ and DZ twins and 2 establish a cohort of intact MZ and DZ female twin pairs as a resource for future studies
In Phase 1 about 1500 individual female twins were identified from the Mid-Atlantic Twin Registry MATR based on self report of a history of irregular periods andor cystic ovaries in the MATR General Health Screening Questionnaire Those twins were surveyed by phone for other traits associated with PCOS In Phase 2 the twins most likely to have PCOS based on their answers to the Phase 1 phone survey will be recontacted for further PCOS screening This includes providing a blood sample for measuring bioavailable testosterone BaT levels Women with elevated BaT levels are likely to have PCOS The women with elevated levels will then be asked to undergo a medical evaluation for PCOS confirmation This includes a physical exam medical history ultrasound 2-hour glucose tolerance and other biochemical blood tests and a Ferriman-Gallwey evaluation for abnormal hirsutism another characteristic of PCOS The women will also be tested for pregnancy and zygosity Their female co-twins will be invited to undergo
In Phase 1 about 1500 individual female twins were identified from the Mid-Atlantic Twin Registry MATR based on self report of a history of irregular periods andor cystic ovaries in the MATR General Health Screening Questionnaire Those twins were surveyed by phone for other traits associated with PCOS In Phase 2 the twins most likely to have PCOS based on their answers to the Phase 1 phone survey will be recontacted for further PCOS screening This includes providing a blood sample for measuring bioavailable testosterone BaT levels Women with elevated BaT levels are likely to have PCOS The women with elevated levels will then be asked to undergo a medical evaluation for PCOS confirmation This includes a physical exam medical history ultrasound 2-hour glucose tolerance and other biochemical blood tests and a Ferriman-Gallwey evaluation for abnormal hirsutism another characteristic of PCOS The women will also be tested for pregnancy and zygosity Their female co-twins will be invited to undergo
Detailed Description:
Polycystic Ovary Syndrome or PCOS is the most common endocrine disorder in women Depending on the strictness of the diagnostic criteria used it is thought to occur in about 6-10 of all women many of whom do not know they have the syndrome Women with PCOS produce abnormally high levels of male hormones hyperandrogenism this counteracts their ovaries ability to make enough of the female hormones estrogen and progesterone needed for normal menstruation PCOS is the number one cause of hormonally related infertility and also increases womens risks for diabetes high blood pressure hypercholesteremia cardiovascular disease and certain cancers It is currently unclear to what extent PCOS and PCOS-associated traits hyperandrogenism hyperinsulinemia insulin resistance type 2 diabetes dyslipidemia hypertension obesity and coronary artery disease are the results of environmental factors or genetic predisposition Therefore the NIEHS Program in Clinical Research is conducting a multi-phase twin study to measure the extent of PCOS heritability and to identify environmental and genetic factors involved in the development of PCOS The proposal described here is for Phase 2 of this study The goals of Phase 2 are to 1 establish more reliable concordance rates and baseline heritability estimates for PCOS in MZ and DZ twins and 2 establish a cohort of intact MZ and DZ female twin pairs with PCOS as a resource for future studies
In Phase 1 about 1500 individual female twins were identified from the Mid-Atlantic Twin Registry MATR based on self report of a history of irregular periods andor cystic ovaries in the MATR General Health Screening Questionnaire Those twins were surveyed by phone for other traits associated with PCOS In Phase 2 the twins most likely to have PCOS based on their answers to the Phase 1 phone survey will be recontacted for further PCOS screening One or both twins in a pair will be screened for elevated levels of testosterone total and free testosterone bioavailable testosterone or BaT free androgen index or FAI Hyperandrogenism is one of the hallmark traits of PCOS and can be exhibited either biochemically elevated testosterone or clinically hirsutism acne hair loss alopecia other If one twin in a pair has an elevated BaT level then both twins in the pair will be asked to undergo a medical evaluation for PCOS confirmation This includes a physical exam medical history ultrasound 2-hour glucose tolerance and other biochemical blood tests and a Ferriman-Gallwey evaluation for abnormal hirsutism another characteristic of PCOS The women will also be tested for pregnancy and zygosity Their female co-twins will be invited to undergo a similar medical evaluation
Depending on their PCOS traits twin pairs in which neither member has elevated testosterone levels might be asked to undergo the medical evaluation as well In clinical practice PCOS diagnoses are often made on women with normal testosterone levels if they have other certain PCOS traits The determination to include pairs in which both members have normal testosterone levels will be made depending on their collective PCOS traits that they reported on their Phase 1 survey
In Phase 1 about 1500 individual female twins were identified from the Mid-Atlantic Twin Registry MATR based on self report of a history of irregular periods andor cystic ovaries in the MATR General Health Screening Questionnaire Those twins were surveyed by phone for other traits associated with PCOS In Phase 2 the twins most likely to have PCOS based on their answers to the Phase 1 phone survey will be recontacted for further PCOS screening One or both twins in a pair will be screened for elevated levels of testosterone total and free testosterone bioavailable testosterone or BaT free androgen index or FAI Hyperandrogenism is one of the hallmark traits of PCOS and can be exhibited either biochemically elevated testosterone or clinically hirsutism acne hair loss alopecia other If one twin in a pair has an elevated BaT level then both twins in the pair will be asked to undergo a medical evaluation for PCOS confirmation This includes a physical exam medical history ultrasound 2-hour glucose tolerance and other biochemical blood tests and a Ferriman-Gallwey evaluation for abnormal hirsutism another characteristic of PCOS The women will also be tested for pregnancy and zygosity Their female co-twins will be invited to undergo a similar medical evaluation
Depending on their PCOS traits twin pairs in which neither member has elevated testosterone levels might be asked to undergo the medical evaluation as well In clinical practice PCOS diagnoses are often made on women with normal testosterone levels if they have other certain PCOS traits The determination to include pairs in which both members have normal testosterone levels will be made depending on their collective PCOS traits that they reported on their Phase 1 survey
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-E-N112 | None | None | None |