ID

39369

Beskrivning

Resistant Starch Insulin Sensitivity Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01027325

Länk

https://clinicaltrials.gov/show/NCT01027325

Nyckelord

Versioner (1)
  1. 2020-01-03 2020-01-03 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

3 januari 2020

DOI

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Creative Commons BY 4.0
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Eligibility Healthy NCT01027325

Engelsk

Eligibility Healthy NCT01027325

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Healthy NCT01027325
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women ≥ 20 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
blood pressure less than 150/90. if on three separate clinic visits blood pressure remains above this level, a subject will be referred to his or her physician for treatment.
Beskrivning

Blood pressure determination

Datatyp

boolean

Alias
UMLS CUI [1]
C0005824
body mass index (bmi) ≥ 20 and ≤ 35 kg/m2.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
non-smoking and does not use nicotine products or recreational drugs.
Beskrivning

Non-smoker | Use of Nicotine product Absent | Use of Recreational Drugs Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0028040
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0242508
UMLS CUI [3,3]
C0332197
agrees to consume no alcohol or dietary supplements during the study.
Beskrivning

Alcohol consumption Absent | Dietary Supplements Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C0332197
total cholesterol and ldl cholesterol <95th percentile for sex and age.
Beskrivning

Serum total cholesterol measurement Percentile | Gender | Age | Serum LDL cholesterol measurement Percentile

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1445957
UMLS CUI [1,2]
C1264641
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0428474
UMLS CUI [4,2]
C1264641
fasting triglycerides <500mg/dl.
Beskrivning

Serum fasting triglyceride measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0582824
homa-ir ≥ 50th percentile for sex.
Beskrivning

Homeostasis model assessment Insulin Resistance Measurement Percentile | Gender

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1829779
UMLS CUI [1,2]
C4049994
UMLS CUI [1,3]
C1264641
UMLS CUI [2]
C0079399
fasting blood sugar (fbs) < 126 mg/dl.
Beskrivning

Fasting Blood Sugar Measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C2825162
hematocrit ≥ 36%.
Beskrivning

Hematocrit level

Datatyp

boolean

Alias
UMLS CUI [1]
C0518014
at least 3 months of a weight stable state. during the study, subjects will be required to maintain their body weight within ± 3% (up to a maximum change of 5 lbs) of their initial weight over the course of any consecutive two weeks.
Beskrivning

Stable body weight Duration | Body Weight Maintenance Required

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0517386
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C4042910
UMLS CUI [2,2]
C1514873
for women of childbearing potential, two barrier methods of contraception must be used throughout the study and urine pregnancy b-hcg will be done at screen (v1) and at all "a" visits (v2a, 3a, 4a). subjects who become pregnant will no longer be allowed to continue the study.
Beskrivning

Childbearing Potential Barrier Contraception Quantity | Childbearing Potential Urine HCG Test | Childbearing Potential Urine pregnancy test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0004764
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0236449
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430056
women will be considered post-menopausal if ≥ 3 years since last menses or no menses for 1-3 years and plasma fsh elevated into postmenopausal range.
Beskrivning

Postmenopausal state | Elevated plasma FSH Consistent with Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C1848191
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0232970
subjects who cannot complete the requirements of the study for reasons determined by the investigator (i.e. non-accessible veins for blood drawing, inability to keep clinic appointments) will not be able to participate in the study.
Beskrivning

Exclusion Criteria | Protocol Compliance Unsuccessful | Blood draw Unsuccessful | Compliance behavior Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1272705
UMLS CUI [3,1]
C0005834
UMLS CUI [3,2]
C1272705
UMLS CUI [4,1]
C1321605
UMLS CUI [4,2]
C0332268
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, hiv, or cancer (other than skin cancer) in the last 5 years.
Beskrivning

Coronary heart disease | Cerebrovascular Disorders | Peripheral Vascular Diseases | Blood Coagulation Disorders | Liver diseases | Kidney Diseases | Diabetes Mellitus | Lung diseases | HIV Infections | Malignant Neoplasms | Exception Skin carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2]
C0007820
UMLS CUI [3]
C0085096
UMLS CUI [4]
C0005779
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0011849
UMLS CUI [8]
C0024115
UMLS CUI [9]
C0019693
UMLS CUI [10]
C0006826
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0699893
taking drugs known to affect lipid metabolism, blood thinning agents or hormones
Beskrivning

Pharmaceutical Preparations Affecting Lipid Metabolism | Anticoagulants | Hormones

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0598783
UMLS CUI [2]
C0003280
UMLS CUI [3]
C0019932
abnormal thyroid stimulating hormone (tsh) levels
Beskrivning

Abnormal thyroid-stimulating hormone level

Datatyp

boolean

Alias
UMLS CUI [1]
C4476968
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Similar models

Eligibility Healthy NCT01027325

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Healthy NCT01027325
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women ≥ 20 years
boolean
C0001779 (UMLS CUI [1])
Blood pressure determination
Item
blood pressure less than 150/90. if on three separate clinic visits blood pressure remains above this level, a subject will be referred to his or her physician for treatment.
boolean
C0005824 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) ≥ 20 and ≤ 35 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Non-smoker | Use of Nicotine product Absent | Use of Recreational Drugs Absent
Item
non-smoking and does not use nicotine products or recreational drugs.
boolean
C0337672 (UMLS CUI [1])
C1524063 (UMLS CUI [2,1])
C0028040 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1524063 (UMLS CUI [3,1])
C0242508 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Alcohol consumption Absent | Dietary Supplements Absent
Item
agrees to consume no alcohol or dietary supplements during the study.
boolean
C0001948 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0242295 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Serum total cholesterol measurement Percentile | Gender | Age | Serum LDL cholesterol measurement Percentile
Item
total cholesterol and ldl cholesterol <95th percentile for sex and age.
boolean
C1445957 (UMLS CUI [1,1])
C1264641 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0428474 (UMLS CUI [4,1])
C1264641 (UMLS CUI [4,2])
Serum fasting triglyceride measurement
Item
fasting triglycerides <500mg/dl.
boolean
C0582824 (UMLS CUI [1])
Homeostasis model assessment Insulin Resistance Measurement Percentile | Gender
Item
homa-ir ≥ 50th percentile for sex.
boolean
C1829779 (UMLS CUI [1,1])
C4049994 (UMLS CUI [1,2])
C1264641 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2])
Fasting Blood Sugar Measurement
Item
fasting blood sugar (fbs) < 126 mg/dl.
boolean
C2825162 (UMLS CUI [1])
Hematocrit level
Item
hematocrit ≥ 36%.
boolean
C0518014 (UMLS CUI [1])
Stable body weight Duration | Body Weight Maintenance Required
Item
at least 3 months of a weight stable state. during the study, subjects will be required to maintain their body weight within ± 3% (up to a maximum change of 5 lbs) of their initial weight over the course of any consecutive two weeks.
boolean
C0517386 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C4042910 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Childbearing Potential Barrier Contraception Quantity | Childbearing Potential Urine HCG Test | Childbearing Potential Urine pregnancy test
Item
for women of childbearing potential, two barrier methods of contraception must be used throughout the study and urine pregnancy b-hcg will be done at screen (v1) and at all "a" visits (v2a, 3a, 4a). subjects who become pregnant will no longer be allowed to continue the study.
boolean
C3831118 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0236449 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430056 (UMLS CUI [3,2])
Postmenopausal state | Elevated plasma FSH Consistent with Postmenopausal state
Item
women will be considered post-menopausal if ≥ 3 years since last menses or no menses for 1-3 years and plasma fsh elevated into postmenopausal range.
boolean
C0232970 (UMLS CUI [1])
C1848191 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0232970 (UMLS CUI [2,3])
Exclusion Criteria | Protocol Compliance Unsuccessful | Blood draw Unsuccessful | Compliance behavior Lacking
Item
subjects who cannot complete the requirements of the study for reasons determined by the investigator (i.e. non-accessible veins for blood drawing, inability to keep clinic appointments) will not be able to participate in the study.
boolean
C0680251 (UMLS CUI [1])
C0525058 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C0005834 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
C1321605 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Coronary heart disease | Cerebrovascular Disorders | Peripheral Vascular Diseases | Blood Coagulation Disorders | Liver diseases | Kidney Diseases | Diabetes Mellitus | Lung diseases | HIV Infections | Malignant Neoplasms | Exception Skin carcinoma
Item
history of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, hiv, or cancer (other than skin cancer) in the last 5 years.
boolean
C0010068 (UMLS CUI [1])
C0007820 (UMLS CUI [2])
C0085096 (UMLS CUI [3])
C0005779 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0011849 (UMLS CUI [7])
C0024115 (UMLS CUI [8])
C0019693 (UMLS CUI [9])
C0006826 (UMLS CUI [10])
C1705847 (UMLS CUI [11,1])
C0699893 (UMLS CUI [11,2])
Pharmaceutical Preparations Affecting Lipid Metabolism | Anticoagulants | Hormones
Item
taking drugs known to affect lipid metabolism, blood thinning agents or hormones
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0598783 (UMLS CUI [1,3])
C0003280 (UMLS CUI [2])
C0019932 (UMLS CUI [3])
Abnormal thyroid-stimulating hormone level
Item
abnormal thyroid stimulating hormone (tsh) levels
boolean
C4476968 (UMLS CUI [1])
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