ID

23730

Descripción

Effect of Diet on Vascular Disease in Pre-Menopausal Women; ODM derived from: https://clinicaltrials.gov/show/NCT00484861

Link

https://clinicaltrials.gov/show/NCT00484861

Palabras clave

Versiones (1)
  1. 12/7/17 12/7/17 -
Subido en

12 de julio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Cardiovascular Diseases NCT00484861

Inglés

Eligibility Cardiovascular Diseases NCT00484861

1 formularios  
Criteria
Descripción

Criteria

african american women: individuals will be considered to be african american if they self-identify as african american and were born in the united states. further they must describe both parents as being african american.
Descripción

Gender | African American

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0085756
caucasian women: individuals will be considered to be caucasian if they self-identify as caucasian.
Descripción

Gender | Caucasians

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0043157
healthy volunteers: the potential enrollee must self identify as a normal volunteer and have this confirmed by having at the screening visit a normal complete blood count, glucose, bun creatinine, liver and thyroid panel.
Descripción

Healthy Volunteers | Normal Volunteers | Full blood count normal | Glucose normal | BUN/Creatinine ratio Normal | Liver Function Tests Normal | Thyroid Function Tests Normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C3661466
UMLS CUI [3]
C0427692
UMLS CUI [4]
C0860800
UMLS CUI [5,1]
C0201922
UMLS CUI [5,2]
C0205307
UMLS CUI [6,1]
C0023901
UMLS CUI [6,2]
C0205307
UMLS CUI [7,1]
C0040130
UMLS CUI [7,2]
C0205307
age between 18 and 65 years: this age range is chosen because tg levels across the lifespan from early adulthood through to postmenopausal status. weare using 65 years of age as a conventional upper limit. in addition, 65 years of age has been used as an age category cut-off by national health and nutrition examination surveys. our goal is to detect ethnic differences in the pathways that allow vascular disease to develop. enrolling women between the ages of 18 and 65 years, maximizes our ability to detect differences in mechanism of action that are truly secondary to ethnicity.
Descripción

Age | Triglycerides measurement | Early adulthood | Postmenopausal state

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0202236
UMLS CUI [3]
C0680085
UMLS CUI [4]
C0232970
weight less than 136 kg (300 lbs): this weight restriction is necessitated by the limitations of the dxa scanner. the dxa platform cannot accommodate subjects who weigh more than 136 kg.
Descripción

Body Weight | DXA Scan Limitation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2,1]
C1959592
UMLS CUI [2,2]
C0449295
bmi between 20 and 45 kg/m2: women in both ethnic groups will be recruited across bmi nonobese and obese categories. therefore we will enroll approximately equal numbers of women from each ethnic group in both bmi categories bmi between 20 and 30 kg/m(2) and bmi between 30 and 45 kg/m(2).
Descripción

Body mass index | Gender | Ethnic group | Obesity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0015031
UMLS CUI [4]
C0028754
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
refusal to agree to use barrier contraception: the dxa scan and ct scan should not be performed if the participant is pregnant. in addition, tg levels are directly affected by pregnancy. even though we will perform pregnancy tests within 7 days of each visit, we also require that the subject agree to abstinence or barrier contraception throughout the study.
Descripción

Barrier Contraception Refused | Pregnancy | Pregnancy Tests Frequency | Sexual Abstinence Requirement | Barrier Contraception Requirement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004764
UMLS CUI [1,2]
C1705116
UMLS CUI [2]
C0032961
UMLS CUI [3,1]
C0032976
UMLS CUI [3,2]
C0439603
UMLS CUI [4,1]
C0036899
UMLS CUI [4,2]
C1514873
UMLS CUI [5,1]
C0004764
UMLS CUI [5,2]
C1514873
medications which affect parameters under investigation: examples include corticosteroids, oral contraceptives, hypoglycemic (oral or injection), hypolipidemic, antihypertensive and antipsychotic agents. oral contraceptives, in particular, are exclusion criteria because the estrogen component of oral contraceptives increase tg levels and would therefore obscure the effect of the test meal on tg levels.
Descripción

Pharmaceutical Preparations Affecting Parameters Investigational | Adrenal Cortex Hormones | Contraceptives, Oral | Oral hypoglycemic | Hypoglycemic Agents Injection | Hypolipidemic Agents | Antihypertensive Agents | Antipsychotic Agents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0449381
UMLS CUI [1,4]
C1517586
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0009905
UMLS CUI [4]
C0359086
UMLS CUI [5,1]
C0020616
UMLS CUI [5,2]
C1828121
UMLS CUI [6]
C0086440
UMLS CUI [7]
C0003364
UMLS CUI [8]
C0040615
medical conditions which affect parameters under investigation: examples include diabetes, thyroid disease, liver disease, pancreatitis, nephrotic syndrome.
Descripción

Pharmaceutical Preparations Affecting Parameters Investigational | Diabetes Mellitus | Thyroid Disease | Liver disease | Pancreatitis | Nephrotic Syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0449381
UMLS CUI [1,4]
C1517586
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0040128
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0030305
UMLS CUI [6]
C0027726
hispanics: the relationship between tg and insulin resistance in hispanic white women is midway between african american and caucasian women. therefore in this initial study to be able to determine the maximum ethnic difference in the relationship between tg and insulin resistance, we will enroll in this protocol study women who self-identify as african american and caucasian and not enroll women who self-identify as hispanic.
Descripción

Hispanics | Gender | White Hispanic | Relationship Triglycerides Insulin Resistance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086409
UMLS CUI [2]
C0079399
UMLS CUI [3]
C1533021
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C0041004
UMLS CUI [4,3]
C0021655
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Similar models

Eligibility Cardiovascular Diseases NCT00484861

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Gender | African American
Item
african american women: individuals will be considered to be african american if they self-identify as african american and were born in the united states. further they must describe both parents as being african american.
boolean
C0079399 (UMLS CUI [1])
C0085756 (UMLS CUI [2])
Gender | Caucasians
Item
caucasian women: individuals will be considered to be caucasian if they self-identify as caucasian.
boolean
C0079399 (UMLS CUI [1])
C0043157 (UMLS CUI [2])
Healthy Volunteers | Normal Volunteers | Full blood count normal | Glucose normal | BUN/Creatinine ratio Normal | Liver Function Tests Normal | Thyroid Function Tests Normal
Item
healthy volunteers: the potential enrollee must self identify as a normal volunteer and have this confirmed by having at the screening visit a normal complete blood count, glucose, bun creatinine, liver and thyroid panel.
boolean
C1708335 (UMLS CUI [1])
C3661466 (UMLS CUI [2])
C0427692 (UMLS CUI [3])
C0860800 (UMLS CUI [4])
C0201922 (UMLS CUI [5,1])
C0205307 (UMLS CUI [5,2])
C0023901 (UMLS CUI [6,1])
C0205307 (UMLS CUI [6,2])
C0040130 (UMLS CUI [7,1])
C0205307 (UMLS CUI [7,2])
Age | Triglycerides measurement | Early adulthood | Postmenopausal state
Item
age between 18 and 65 years: this age range is chosen because tg levels across the lifespan from early adulthood through to postmenopausal status. weare using 65 years of age as a conventional upper limit. in addition, 65 years of age has been used as an age category cut-off by national health and nutrition examination surveys. our goal is to detect ethnic differences in the pathways that allow vascular disease to develop. enrolling women between the ages of 18 and 65 years, maximizes our ability to detect differences in mechanism of action that are truly secondary to ethnicity.
boolean
C0001779 (UMLS CUI [1])
C0202236 (UMLS CUI [2])
C0680085 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
Body Weight | DXA Scan Limitation
Item
weight less than 136 kg (300 lbs): this weight restriction is necessitated by the limitations of the dxa scanner. the dxa platform cannot accommodate subjects who weigh more than 136 kg.
boolean
C0005910 (UMLS CUI [1])
C1959592 (UMLS CUI [2,1])
C0449295 (UMLS CUI [2,2])
Body mass index | Gender | Ethnic group | Obesity
Item
bmi between 20 and 45 kg/m2: women in both ethnic groups will be recruited across bmi nonobese and obese categories. therefore we will enroll approximately equal numbers of women from each ethnic group in both bmi categories bmi between 20 and 30 kg/m(2) and bmi between 30 and 45 kg/m(2).
boolean
C1305855 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0015031 (UMLS CUI [3])
C0028754 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Barrier Contraception Refused | Pregnancy | Pregnancy Tests Frequency | Sexual Abstinence Requirement | Barrier Contraception Requirement
Item
refusal to agree to use barrier contraception: the dxa scan and ct scan should not be performed if the participant is pregnant. in addition, tg levels are directly affected by pregnancy. even though we will perform pregnancy tests within 7 days of each visit, we also require that the subject agree to abstinence or barrier contraception throughout the study.
boolean
C0004764 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0032976 (UMLS CUI [3,1])
C0439603 (UMLS CUI [3,2])
C0036899 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0004764 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
Pharmaceutical Preparations Affecting Parameters Investigational | Adrenal Cortex Hormones | Contraceptives, Oral | Oral hypoglycemic | Hypoglycemic Agents Injection | Hypolipidemic Agents | Antihypertensive Agents | Antipsychotic Agents
Item
medications which affect parameters under investigation: examples include corticosteroids, oral contraceptives, hypoglycemic (oral or injection), hypolipidemic, antihypertensive and antipsychotic agents. oral contraceptives, in particular, are exclusion criteria because the estrogen component of oral contraceptives increase tg levels and would therefore obscure the effect of the test meal on tg levels.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0449381 (UMLS CUI [1,3])
C1517586 (UMLS CUI [1,4])
C0001617 (UMLS CUI [2])
C0009905 (UMLS CUI [3])
C0359086 (UMLS CUI [4])
C0020616 (UMLS CUI [5,1])
C1828121 (UMLS CUI [5,2])
C0086440 (UMLS CUI [6])
C0003364 (UMLS CUI [7])
C0040615 (UMLS CUI [8])
Pharmaceutical Preparations Affecting Parameters Investigational | Diabetes Mellitus | Thyroid Disease | Liver disease | Pancreatitis | Nephrotic Syndrome
Item
medical conditions which affect parameters under investigation: examples include diabetes, thyroid disease, liver disease, pancreatitis, nephrotic syndrome.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0449381 (UMLS CUI [1,3])
C1517586 (UMLS CUI [1,4])
C0011849 (UMLS CUI [2])
C0040128 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0030305 (UMLS CUI [5])
C0027726 (UMLS CUI [6])
Hispanics | Gender | White Hispanic | Relationship Triglycerides Insulin Resistance
Item
hispanics: the relationship between tg and insulin resistance in hispanic white women is midway between african american and caucasian women. therefore in this initial study to be able to determine the maximum ethnic difference in the relationship between tg and insulin resistance, we will enroll in this protocol study women who self-identify as african american and caucasian and not enroll women who self-identify as hispanic.
boolean
C0086409 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C1533021 (UMLS CUI [3])
C0439849 (UMLS CUI [4,1])
C0041004 (UMLS CUI [4,2])
C0021655 (UMLS CUI [4,3])
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