ID

39133

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01562782

Trefwoorden

Versies (1)
  1. 04-12-19 04-12-19 -
Houder van rechten

See clinicaltrials.gov

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4 december 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Elevated Triglycerides NCT01562782

Engels

Eligibility Elevated Triglycerides NCT01562782

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age

Datatype

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).
Beschrijving

South Asian | Caucasians

Datatype

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.
Beschrijving

Body mass index | Obesity Absent

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Alcohol Abstinence Duration

Datatype

boolean

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

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

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

Datatype

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.
Beschrijving

Pharmaceutical Preparations Affecting Lipids | Contraceptives, Oral, Hormonal

Datatype

boolean

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

Illness Recent

Datatype

boolean

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

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

Datatype

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
Beschrijving

Tobacco use

Datatype

boolean

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

Alcohol abuse Drinks U/day | Illicit drug use

Datatype

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
Beschrijving

Mental Disorders, Severe

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

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

Study Subject Participation Status | Investigational New Drugs

Datatype

boolean

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

Diet unusual | Physical activity Extreme

Datatype

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
Beschrijving

Condition Study Subject Participation Status Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
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Similar models

Eligibility Elevated Triglycerides NCT01562782

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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