ID

31337

Description

Effect of Amount and Type of Dietary Carbohydrates on Risk for Cardiovascular Heart Disease and Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00608049

Link

https://clinicaltrials.gov/show/NCT00608049

Keywords

Versions (1)
  1. 8/15/18 8/15/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 15, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Overweight NCT00608049

English

Eligibility Overweight NCT00608049

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Overweight NCT00608049
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
sbp of 120 to 159 mmhg and dbp less than 100 mmhg at study entry (mean over three screening visits) (note: participants with stage 2 hypertension [sbp greater than 160 mmhg or dbp greater than 100 mmhg] based on the mean over three screening visits will be excluded, as will participants with a mean sbp greater than 170 mmhg or dbp greater than 105 mmhg at any one visit)
Description

Systolic Pressure | Diastolic blood pressure | Hypertensive disease Stage

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
UMLS CUI [3,1]
C0020538
UMLS CUI [3,2]
C0699749
overweight or obese, as defined by a body mass index (bmi) greater than 25 kg/m2
Description

Overweight | Obesity | Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C0497406
UMLS CUI [2]
C0028754
UMLS CUI [3]
C1305855
willing to eat at least one on-site meal per day, 5 days per week, and willing to eat study diets and nothing else during controlled feeding periods
Description

Eating Meal Quantity per day | Study Diet Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0013470
UMLS CUI [1,2]
C1998602
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0439505
UMLS CUI [2,1]
C2603343
UMLS CUI [2,2]
C0012155
UMLS CUI [2,3]
C0600109
medication exclusion criteria:
Description

Pharmaceutical Preparations Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0680251
symptomatic ischemic heart disease (e.g., angina pectoris)
Description

Myocardial Ischemia Symptomatic | Angina Pectoris

Data type

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0002962
regular use of medications that raise or lower bp during the 2 months prior to study entry
Description

Pharmaceutical Preparations Regular Resulting in Elevated blood pressure | Antihypertensive Agents Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C0332294
UMLS CUI [1,4]
C0497247
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0205272
use of a lipid lowering agent in the 3 weeks prior to study entry
Description

Hypolipidemic Agents

Data type

boolean

Alias
UMLS CUI [1]
C0086440
unstable dose of hormone replacement therapy, thyroid hormone replacement therapy, and psychotropic medications known to cause weight gain or affect the outcome variables (unstable is defined as a change in dose within 2 months of study entry)
Description

Hormone replacement therapy Dose Unstable | Thyroid hormone replacement therapy Dose Unstable | Psychotropic Drugs Dose Unstable | Psychotropic Drugs Causing Weight Gain | Psychotropic Drugs Affecting Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0282402
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0443343
UMLS CUI [2,1]
C2242640
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0443343
UMLS CUI [3,1]
C0033978
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0443343
UMLS CUI [4,1]
C0033978
UMLS CUI [4,2]
C0678227
UMLS CUI [4,3]
C0043094
UMLS CUI [5,1]
C0033978
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0683954
use of insulin, oral hypoglycemic agent, lithium, oral corticosteroid, anti-psychotic drugs, weight loss medications, nitrate, or digitalis
Description

Insulin | Oral hypoglycemic | Lithium | Adrenal Cortex Hormones Oral | Antipsychotic Agents | Weight-Loss Agents | Nitrate | Digitalis preparation

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0359086
UMLS CUI [3]
C0023870
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C1527415
UMLS CUI [5]
C0040615
UMLS CUI [6]
C0376606
UMLS CUI [7]
C0028125
UMLS CUI [8]
C0304520
medical history exclusion criteria:
Description

Medical History Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0680251
active or prior cvd (e.g., stroke, heart attack, percutaneous transluminal coronary angioplasty, coronary artery bypass graft, congestive heart failure, symptomatic ischemic heart disease [angina], or arteriosclerotic cardiovascular disease-related therapeutic procedure)
Description

Cardiovascular Disease | Cerebrovascular accident | Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery | Congestive heart failure | Myocardial Ischemia Symptomatic | Angina Pectoris | Therapeutic procedure arteriosclerotic Relationship Cardiovascular Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0027051
UMLS CUI [4]
C2936173
UMLS CUI [5]
C0010055
UMLS CUI [6]
C0018802
UMLS CUI [7,1]
C0151744
UMLS CUI [7,2]
C0231220
UMLS CUI [8]
C0002962
UMLS CUI [9,1]
C0087111
UMLS CUI [9,2]
C0333477
UMLS CUI [9,3]
C0439849
UMLS CUI [9,4]
C0007222
diabetes mellitus
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
cancer diagnosis or treatment in the 2 years prior to study entry (note: people with non-melanoma skin cancer, localized breast cancer, or localized prostate cancer can enroll if they did not require systemic chemotherapy)
Description

Malignant Neoplasms | Cancer treatment | Exception Skin carcinoma | Exception Breast Carcinoma Localized | Exception Prostate carcinoma Localized | Relationship Systemic Chemotherapy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0920425
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0678222
UMLS CUI [4,3]
C0392752
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0600139
UMLS CUI [5,3]
C0392752
UMLS CUI [6,1]
C0439849
UMLS CUI [6,2]
C1883256
UMLS CUI [6,3]
C0332197
active inflammatory bowel disease, malabsorption, or major gastrointestinal resection
Description

Inflammatory Bowel Disease | Malabsorption | Gastrointestinal tract excision Major

Data type

boolean

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C3714745
UMLS CUI [3,1]
C1293479
UMLS CUI [3,2]
C0205164
renal insufficiency as determined by a serum creatinine greater than 1.2 mg/dl for women or greater than 1.4 mg/dl for men (these participants can enroll if their estimated glomerular filtration rate is greater than 40 ml/min by either the cockcroft-gault equation or the simplified modification of diet in renal disease equation)
Description

Renal Insufficiency | Creatinine measurement, serum | Gender | Estimated Glomerular Filtration Rate Cockcroft-Gault formula | GFR estimation by MDRD

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
UMLS CUI [4,1]
C3811844
UMLS CUI [4,2]
C2924627
UMLS CUI [5]
C2170215
emergency room visit or hospital stay for asthma or chronic obstructive pulmonary disease in the 6 months prior to study entry
Description

Emergency department visit Asthma | Hospital Stay Asthma | Emergency department visit Chronic Obstructive Airway Disease | Hospital Stay Chronic Obstructive Airway Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0586082
UMLS CUI [1,2]
C0004096
UMLS CUI [2,1]
C3489408
UMLS CUI [2,2]
C0004096
UMLS CUI [3,1]
C0586082
UMLS CUI [3,2]
C0024117
UMLS CUI [4,1]
C3489408
UMLS CUI [4,2]
C0024117
any serious illness not otherwise specified that would interfere with participation
Description

Illness Serious Interferes with Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
laboratory exclusion criteria:
Description

Laboratory Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0680251
fasting ldl cholesterol greater than 220 mg/dl and triglycerides greater than 750 mg/dl
Description

Serum fasting LDL cholesterol measurement | Triglycerides measurement

Data type

boolean

Alias
UMLS CUI [1]
C0582830
UMLS CUI [2]
C0202236
fasting blood glucose greater than 125 mg/dl
Description

Fasting blood glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428568
serum transaminase greater than 2 times the upper range of normal, or a clinical diagnosis of hepatitis
Description

Serum transaminase increased | Hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0859350
UMLS CUI [2]
C0019158
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Similar models

Eligibility Overweight NCT00608049

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Overweight NCT00608049
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Systolic Pressure | Diastolic blood pressure | Hypertensive disease Stage
Item
sbp of 120 to 159 mmhg and dbp less than 100 mmhg at study entry (mean over three screening visits) (note: participants with stage 2 hypertension [sbp greater than 160 mmhg or dbp greater than 100 mmhg] based on the mean over three screening visits will be excluded, as will participants with a mean sbp greater than 170 mmhg or dbp greater than 105 mmhg at any one visit)
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0020538 (UMLS CUI [3,1])
C0699749 (UMLS CUI [3,2])
Overweight | Obesity | Body mass index
Item
overweight or obese, as defined by a body mass index (bmi) greater than 25 kg/m2
boolean
C0497406 (UMLS CUI [1])
C0028754 (UMLS CUI [2])
C1305855 (UMLS CUI [3])
Eating Meal Quantity per day | Study Diet Willing
Item
willing to eat at least one on-site meal per day, 5 days per week, and willing to eat study diets and nothing else during controlled feeding periods
boolean
C0013470 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0439505 (UMLS CUI [1,4])
C2603343 (UMLS CUI [2,1])
C0012155 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Pharmaceutical Preparations Exclusion Criteria
Item
medication exclusion criteria:
boolean
C0013227 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Myocardial Ischemia Symptomatic | Angina Pectoris
Item
symptomatic ischemic heart disease (e.g., angina pectoris)
boolean
C0151744 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2])
Pharmaceutical Preparations Regular Resulting in Elevated blood pressure | Antihypertensive Agents Regular
Item
regular use of medications that raise or lower bp during the 2 months prior to study entry
boolean
C0013227 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0332294 (UMLS CUI [1,3])
C0497247 (UMLS CUI [1,4])
C0003364 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
Hypolipidemic Agents
Item
use of a lipid lowering agent in the 3 weeks prior to study entry
boolean
C0086440 (UMLS CUI [1])
Hormone replacement therapy Dose Unstable | Thyroid hormone replacement therapy Dose Unstable | Psychotropic Drugs Dose Unstable | Psychotropic Drugs Causing Weight Gain | Psychotropic Drugs Affecting Research results
Item
unstable dose of hormone replacement therapy, thyroid hormone replacement therapy, and psychotropic medications known to cause weight gain or affect the outcome variables (unstable is defined as a change in dose within 2 months of study entry)
boolean
C0282402 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C2242640 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
C0033978 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0443343 (UMLS CUI [3,3])
C0033978 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C0043094 (UMLS CUI [4,3])
C0033978 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0683954 (UMLS CUI [5,3])
Insulin | Oral hypoglycemic | Lithium | Adrenal Cortex Hormones Oral | Antipsychotic Agents | Weight-Loss Agents | Nitrate | Digitalis preparation
Item
use of insulin, oral hypoglycemic agent, lithium, oral corticosteroid, anti-psychotic drugs, weight loss medications, nitrate, or digitalis
boolean
C0021641 (UMLS CUI [1])
C0359086 (UMLS CUI [2])
C0023870 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0040615 (UMLS CUI [5])
C0376606 (UMLS CUI [6])
C0028125 (UMLS CUI [7])
C0304520 (UMLS CUI [8])
Medical History Exclusion Criteria
Item
medical history exclusion criteria:
boolean
C0262926 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Cardiovascular Disease | Cerebrovascular accident | Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery | Congestive heart failure | Myocardial Ischemia Symptomatic | Angina Pectoris | Therapeutic procedure arteriosclerotic Relationship Cardiovascular Diseases
Item
active or prior cvd (e.g., stroke, heart attack, percutaneous transluminal coronary angioplasty, coronary artery bypass graft, congestive heart failure, symptomatic ischemic heart disease [angina], or arteriosclerotic cardiovascular disease-related therapeutic procedure)
boolean
C0007222 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C2936173 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C0018802 (UMLS CUI [6])
C0151744 (UMLS CUI [7,1])
C0231220 (UMLS CUI [7,2])
C0002962 (UMLS CUI [8])
C0087111 (UMLS CUI [9,1])
C0333477 (UMLS CUI [9,2])
C0439849 (UMLS CUI [9,3])
C0007222 (UMLS CUI [9,4])
Diabetes Mellitus
Item
diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Malignant Neoplasms | Cancer treatment | Exception Skin carcinoma | Exception Breast Carcinoma Localized | Exception Prostate carcinoma Localized | Relationship Systemic Chemotherapy Absent
Item
cancer diagnosis or treatment in the 2 years prior to study entry (note: people with non-melanoma skin cancer, localized breast cancer, or localized prostate cancer can enroll if they did not require systemic chemotherapy)
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
C0392752 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0600139 (UMLS CUI [5,2])
C0392752 (UMLS CUI [5,3])
C0439849 (UMLS CUI [6,1])
C1883256 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Inflammatory Bowel Disease | Malabsorption | Gastrointestinal tract excision Major
Item
active inflammatory bowel disease, malabsorption, or major gastrointestinal resection
boolean
C0021390 (UMLS CUI [1])
C3714745 (UMLS CUI [2])
C1293479 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
Renal Insufficiency | Creatinine measurement, serum | Gender | Estimated Glomerular Filtration Rate Cockcroft-Gault formula | GFR estimation by MDRD
Item
renal insufficiency as determined by a serum creatinine greater than 1.2 mg/dl for women or greater than 1.4 mg/dl for men (these participants can enroll if their estimated glomerular filtration rate is greater than 40 ml/min by either the cockcroft-gault equation or the simplified modification of diet in renal disease equation)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C3811844 (UMLS CUI [4,1])
C2924627 (UMLS CUI [4,2])
C2170215 (UMLS CUI [5])
Emergency department visit Asthma | Hospital Stay Asthma | Emergency department visit Chronic Obstructive Airway Disease | Hospital Stay Chronic Obstructive Airway Disease
Item
emergency room visit or hospital stay for asthma or chronic obstructive pulmonary disease in the 6 months prior to study entry
boolean
C0586082 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C3489408 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0586082 (UMLS CUI [3,1])
C0024117 (UMLS CUI [3,2])
C3489408 (UMLS CUI [4,1])
C0024117 (UMLS CUI [4,2])
Illness Serious Interferes with Study Subject Participation Status
Item
any serious illness not otherwise specified that would interfere with participation
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Laboratory Exclusion Criteria
Item
laboratory exclusion criteria:
boolean
C0022877 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Serum fasting LDL cholesterol measurement | Triglycerides measurement
Item
fasting ldl cholesterol greater than 220 mg/dl and triglycerides greater than 750 mg/dl
boolean
C0582830 (UMLS CUI [1])
C0202236 (UMLS CUI [2])
Fasting blood glucose measurement
Item
fasting blood glucose greater than 125 mg/dl
boolean
C0428568 (UMLS CUI [1])
Serum transaminase increased | Hepatitis
Item
serum transaminase greater than 2 times the upper range of normal, or a clinical diagnosis of hepatitis
boolean
C0859350 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
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