ID

39133

Descripción

Change of Fructose to Fat in South Asians; ODM derived from: https://clinicaltrials.gov/show/NCT01562782

Link

https://clinicaltrials.gov/show/NCT01562782

Palabras clave

Versiones (1)
  1. 4/12/19 4/12/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

4 de diciembre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Elevated Triglycerides NCT01562782

Inglés

Eligibility Elevated Triglycerides NCT01562782

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females, 18-35 years of age.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
south asian or caucasian descent through self-identification (south asians are to have both biological parents with ancestry from india, pakistan, sri lanka, nepal and bangladesh and no known non-south asian ancestry in parents; caucasians are to have both biological parents who self-identify as caucasian and no known non-caucasian ancestry in parents).
Descripción

South Asian | Caucasians

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519427
UMLS CUI [2]
C0043157
body mass index (bmi) 18.0-24.9 kg/m2 with no history of obesity.
Descripción

Body mass index | Obesity Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2,1]
C0028754
UMLS CUI [2,2]
C0332197
fasting glucose <100 mg/dl, 2h glucose ogtt < 140 mg/dl.
Descripción

Glucose measurement, fasting | 2-hour postprandial blood glucose measurement | Oral Glucose Tolerance Test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202045
UMLS CUI [2]
C2238058
UMLS CUI [3]
C0029161
tg <200 mg/dl, hdl cholesterol >30 mg/dl, ldl cholesterol <160 mg/dl.
Descripción

Triglycerides measurement | Serum HDL cholesterol measurement | Serum LDL cholesterol measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202236
UMLS CUI [2]
C0428472
UMLS CUI [3]
C0428474
willing and able to stop fish oil, fiber supplement, other non-prescribed vitamins/supplements for 1 week prior to visit #2 until completion of study.
Descripción

Fish Oil Discontinue Willing | Fish Oil Discontinue Able | Fiber Supplements Discontinue Willing | Fiber Supplements Discontinue Able | Vitamins Discontinue Willing | Vitamins Discontinue Able | Supplements Discontinue Willing | Supplements Discontinue Able

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0016157
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0016157
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0085732
UMLS CUI [3,1]
C0012173
UMLS CUI [3,2]
C0242295
UMLS CUI [3,3]
C1444662
UMLS CUI [3,4]
C0600109
UMLS CUI [4,1]
C0012173
UMLS CUI [4,2]
C0242295
UMLS CUI [4,3]
C1444662
UMLS CUI [4,4]
C0085732
UMLS CUI [5,1]
C0042890
UMLS CUI [5,2]
C1444662
UMLS CUI [5,3]
C0600109
UMLS CUI [6,1]
C0042890
UMLS CUI [6,2]
C1444662
UMLS CUI [6,3]
C0085732
UMLS CUI [7,1]
C0242295
UMLS CUI [7,2]
C1444662
UMLS CUI [7,3]
C0600109
UMLS CUI [8,1]
C0242295
UMLS CUI [8,2]
C1444662
UMLS CUI [8,3]
C0085732
willing to not drink alcohol for 24-hours before visit #2.
Descripción

Alcohol Abstinence Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0678274
UMLS CUI [1,2]
C0449238
willing and able to provide informed consent.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of diabetes or other endocrine disorder, hepatitis or other liver disorder, hiv, or autoimmune disease.
Descripción

Diabetes Mellitus | Endocrine System Disease | Hepatitis | Liver disease | HIV Infection | Autoimmune Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0014130
UMLS CUI [3]
C0019158
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0019693
UMLS CUI [6]
C0004364
medication(s) known to affect lipids, including hormonal contraceptives.
Descripción

Pharmaceutical Preparations Affecting Lipids | Contraceptives, Oral, Hormonal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0023779
UMLS CUI [2]
C0009907
recent acute illness
Descripción

Illness Recent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0332185
gastrointestinal disease resulting in significant gi dysfunction or malabsorption.
Descripción

Gastrointestinal Disease Resulting in Gastrointestinal dysfunction | Gastrointestinal Disease Resulting in Malabsorption

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0679407
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C3714745
cigarette smoking
Descripción

Tobacco use

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0543414
history of ethanol abuse (current intake >2 drinks/day) or illicit drugs.
Descripción

Alcohol abuse Drinks U/day | Illicit drug use

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0456683
UMLS CUI [2]
C0281875
history of severe psychiatric illness
Descripción

Mental Disorders, Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4046029
if female, pregnant or breastfeeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participation in an investigational drug study within one month of screening.
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
unusual diet or extreme level of physical activity
Descripción

Diet unusual | Physical activity Extreme

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2163366
UMLS CUI [2,1]
C0026606
UMLS CUI [2,2]
C0205403
have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
Descripción

Condition Study Subject Participation Status Excluded

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
Volver a la parte superior de la página

Similar models

Eligibility Elevated Triglycerides NCT01562782

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females, 18-35 years of age.
boolean
C0001779 (UMLS CUI [1])
South Asian | Caucasians
Item
south asian or caucasian descent through self-identification (south asians are to have both biological parents with ancestry from india, pakistan, sri lanka, nepal and bangladesh and no known non-south asian ancestry in parents; caucasians are to have both biological parents who self-identify as caucasian and no known non-caucasian ancestry in parents).
boolean
C1519427 (UMLS CUI [1])
C0043157 (UMLS CUI [2])
Body mass index | Obesity Absent
Item
body mass index (bmi) 18.0-24.9 kg/m2 with no history of obesity.
boolean
C1305855 (UMLS CUI [1])
C0028754 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Glucose measurement, fasting | 2-hour postprandial blood glucose measurement | Oral Glucose Tolerance Test
Item
fasting glucose <100 mg/dl, 2h glucose ogtt < 140 mg/dl.
boolean
C0202045 (UMLS CUI [1])
C2238058 (UMLS CUI [2])
C0029161 (UMLS CUI [3])
Triglycerides measurement | Serum HDL cholesterol measurement | Serum LDL cholesterol measurement
Item
tg <200 mg/dl, hdl cholesterol >30 mg/dl, ldl cholesterol <160 mg/dl.
boolean
C0202236 (UMLS CUI [1])
C0428472 (UMLS CUI [2])
C0428474 (UMLS CUI [3])
Fish Oil Discontinue Willing | Fish Oil Discontinue Able | Fiber Supplements Discontinue Willing | Fiber Supplements Discontinue Able | Vitamins Discontinue Willing | Vitamins Discontinue Able | Supplements Discontinue Willing | Supplements Discontinue Able
Item
willing and able to stop fish oil, fiber supplement, other non-prescribed vitamins/supplements for 1 week prior to visit #2 until completion of study.
boolean
C0016157 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0016157 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
C0012173 (UMLS CUI [3,1])
C0242295 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
C0600109 (UMLS CUI [3,4])
C0012173 (UMLS CUI [4,1])
C0242295 (UMLS CUI [4,2])
C1444662 (UMLS CUI [4,3])
C0085732 (UMLS CUI [4,4])
C0042890 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
C0600109 (UMLS CUI [5,3])
C0042890 (UMLS CUI [6,1])
C1444662 (UMLS CUI [6,2])
C0085732 (UMLS CUI [6,3])
C0242295 (UMLS CUI [7,1])
C1444662 (UMLS CUI [7,2])
C0600109 (UMLS CUI [7,3])
C0242295 (UMLS CUI [8,1])
C1444662 (UMLS CUI [8,2])
C0085732 (UMLS CUI [8,3])
Alcohol Abstinence Duration
Item
willing to not drink alcohol for 24-hours before visit #2.
boolean
C0678274 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Informed Consent
Item
willing and able to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus | Endocrine System Disease | Hepatitis | Liver disease | HIV Infection | Autoimmune Disease
Item
history of diabetes or other endocrine disorder, hepatitis or other liver disorder, hiv, or autoimmune disease.
boolean
C0011849 (UMLS CUI [1])
C0014130 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0019693 (UMLS CUI [5])
C0004364 (UMLS CUI [6])
Pharmaceutical Preparations Affecting Lipids | Contraceptives, Oral, Hormonal
Item
medication(s) known to affect lipids, including hormonal contraceptives.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0023779 (UMLS CUI [1,3])
C0009907 (UMLS CUI [2])
Illness Recent
Item
recent acute illness
boolean
C0221423 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Gastrointestinal Disease Resulting in Gastrointestinal dysfunction | Gastrointestinal Disease Resulting in Malabsorption
Item
gastrointestinal disease resulting in significant gi dysfunction or malabsorption.
boolean
C0017178 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0679407 (UMLS CUI [1,3])
C0017178 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C3714745 (UMLS CUI [2,3])
Tobacco use
Item
cigarette smoking
boolean
C0543414 (UMLS CUI [1])
Alcohol abuse Drinks U/day | Illicit drug use
Item
history of ethanol abuse (current intake >2 drinks/day) or illicit drugs.
boolean
C0085762 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0281875 (UMLS CUI [2])
Mental Disorders, Severe
Item
history of severe psychiatric illness
boolean
C4046029 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
if female, pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
participation in an investigational drug study within one month of screening.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Diet unusual | Physical activity Extreme
Item
unusual diet or extreme level of physical activity
boolean
C2163366 (UMLS CUI [1])
C0026606 (UMLS CUI [2,1])
C0205403 (UMLS CUI [2,2])
Condition Study Subject Participation Status Excluded
Item
have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial