ID

30573

Beskrivning

Beef in an Optimal Lean Diet (BOLD) Effects on Metabolic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT00937638

Länk

https://clinicaltrials.gov/show/NCT00937638

Nyckelord

  1. 2018-06-16 2018-06-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 juni 2018

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Metabolic Syndrome NCT00937638

Eligibility Metabolic Syndrome NCT00937638

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
(bmi 27-42 kg/m2)
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
three or more of the following risk factors (defined as having metsyn):
Beskrivning

Risk factors Quantity | Metabolic Syndrome

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0524620
abdominal obesity [waist circumference > 102 cm (40 inches) in men and > 88 cm (35 inches) in women],
Beskrivning

Obesity, Abdominal | Waist Circumference | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0311277
UMLS CUI [2]
C0455829
UMLS CUI [3]
C0079399
elevated blood glucose [> 110mg/dl (6.1 mmol/l)]
Beskrivning

Hyperglycemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0020456
elevated tg [>150 mg/dl (1.7 mmol/l)]
Beskrivning

Hypertriglyceridemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0020557
low hdl-c [<40 mg/dl (1.03 mmol/l) in men and <50 mg/dl (1.29 mmol/l) in women]
Beskrivning

Low serum HDL cholesterol | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C4313266
UMLS CUI [2]
C0079399
hypertension (systolic blood pressure > 130 mmhg or diastolic blood pressure > 85 mmhg)*
Beskrivning

Hypertensive disease | Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
bp medication accepted if bp stable and less than 160/100mm hg
Beskrivning

Pharmaceutical Preparations Blood Pressure | Stable blood pressure | Blood pressure determination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0005823
UMLS CUI [2]
C0428896
UMLS CUI [3]
C0005824
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
a history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on medication)
Beskrivning

Myocardial Infarction | Cerebrovascular accident | Diabetes Mellitus | Liver diseases | Kidney Diseases | Thyroid Diseases | Exception Controlled with medications

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0040128
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0742801
lactation, pregnancy, or desire to become pregnant during the study
Beskrivning

Breast Feeding | Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0032992
intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens, stanol/sterol supplemented foods)
Beskrivning

Cholesterol-lowering diet Supplements | Psyllium | Fish Oil Oral Capsule | Soybean Lecithin | Niacin | Dietary Fiber | Flax | Phytoestrogens | Plant stanol ester Dietary Supplements | Dietary Sterol Supplements

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0311170
UMLS CUI [1,2]
C0242295
UMLS CUI [2]
C0033979
UMLS CUI [3]
C1617119
UMLS CUI [4]
C0872912
UMLS CUI [5]
C0027996
UMLS CUI [6]
C0012173
UMLS CUI [7]
C0995001
UMLS CUI [8]
C0071011
UMLS CUI [9,1]
C0872973
UMLS CUI [9,2]
C0242295
UMLS CUI [10,1]
C2348285
UMLS CUI [10,2]
C0242295
high alcohol consumption (≥ 14 drinks/week)
Beskrivning

Alcohol consumption High | Alcoholic Drinks Weekly

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205250
UMLS CUI [2,1]
C0001967
UMLS CUI [2,2]
C0332174
participation in regular physical activity (> 1 formal session/week)
Beskrivning

Regular physical activity Frequency

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0815170
UMLS CUI [1,2]
C0439603
lipid or glucose lowering medication
Beskrivning

Hypolipidemic Agents | Hypoglycemic Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0086440
UMLS CUI [2]
C0020616

Similar models

Eligibility Metabolic Syndrome NCT00937638

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
(bmi 27-42 kg/m2)
boolean
C1305855 (UMLS CUI [1])
Risk factors Quantity | Metabolic Syndrome
Item
three or more of the following risk factors (defined as having metsyn):
boolean
C0035648 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0524620 (UMLS CUI [2])
Obesity, Abdominal | Waist Circumference | Gender
Item
abdominal obesity [waist circumference > 102 cm (40 inches) in men and > 88 cm (35 inches) in women],
boolean
C0311277 (UMLS CUI [1])
C0455829 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Hyperglycemia
Item
elevated blood glucose [> 110mg/dl (6.1 mmol/l)]
boolean
C0020456 (UMLS CUI [1])
Hypertriglyceridemia
Item
elevated tg [>150 mg/dl (1.7 mmol/l)]
boolean
C0020557 (UMLS CUI [1])
Low serum HDL cholesterol | Gender
Item
low hdl-c [<40 mg/dl (1.03 mmol/l) in men and <50 mg/dl (1.29 mmol/l) in women]
boolean
C4313266 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Hypertensive disease | Systolic Pressure | Diastolic blood pressure
Item
hypertension (systolic blood pressure > 130 mmhg or diastolic blood pressure > 85 mmhg)*
boolean
C0020538 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Pharmaceutical Preparations Blood Pressure | Stable blood pressure | Blood pressure determination
Item
bp medication accepted if bp stable and less than 160/100mm hg
boolean
C0013227 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
C0428896 (UMLS CUI [2])
C0005824 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Myocardial Infarction | Cerebrovascular accident | Diabetes Mellitus | Liver diseases | Kidney Diseases | Thyroid Diseases | Exception Controlled with medications
Item
a history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on medication)
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0040128 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C0742801 (UMLS CUI [7,2])
Breast Feeding | Pregnancy | Pregnancy, Planned
Item
lactation, pregnancy, or desire to become pregnant during the study
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Cholesterol-lowering diet Supplements | Psyllium | Fish Oil Oral Capsule | Soybean Lecithin | Niacin | Dietary Fiber | Flax | Phytoestrogens | Plant stanol ester Dietary Supplements | Dietary Sterol Supplements
Item
intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens, stanol/sterol supplemented foods)
boolean
C0311170 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
C0033979 (UMLS CUI [2])
C1617119 (UMLS CUI [3])
C0872912 (UMLS CUI [4])
C0027996 (UMLS CUI [5])
C0012173 (UMLS CUI [6])
C0995001 (UMLS CUI [7])
C0071011 (UMLS CUI [8])
C0872973 (UMLS CUI [9,1])
C0242295 (UMLS CUI [9,2])
C2348285 (UMLS CUI [10,1])
C0242295 (UMLS CUI [10,2])
Alcohol consumption High | Alcoholic Drinks Weekly
Item
high alcohol consumption (≥ 14 drinks/week)
boolean
C0001948 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C0001967 (UMLS CUI [2,1])
C0332174 (UMLS CUI [2,2])
Regular physical activity Frequency
Item
participation in regular physical activity (> 1 formal session/week)
boolean
C0815170 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Hypolipidemic Agents | Hypoglycemic Agents
Item
lipid or glucose lowering medication
boolean
C0086440 (UMLS CUI [1])
C0020616 (UMLS CUI [2])

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