ID

25649

Descrizione

Pilot Study to Assess Pre-packaged, Portion-controlled Meal Plan on Weight Loss; ODM derived from: https://clinicaltrials.gov/show/NCT00593476

collegamento

https://clinicaltrials.gov/show/NCT00593476

Keywords

versioni (1)
  1. 08/09/17 08/09/17 -
Caricato su

8 settembre 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00593476

Inglese

Eligibility Type 2 Diabetes NCT00593476

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must meet all of the following criteria.
Descrizione

Criteria Fulfill

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. type 2 diabetic men and non-pregnant or non-lactating women between the ages of 21 to 75
Descrizione

Diabetes Mellitus, Non-Insulin-Dependent | Pregnancy Absent | Breast Feeding Absent | Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0032961
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0001779
2. bmi ≥ 25 and ≤ 50
Descrizione

Body mass index

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1305855
3. subjects must be willing to comply with all study-related procedures
Descrizione

Protocol Compliance

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0525058
4. participant with screening hba1c ≥ 6.0
Descrizione

Glycosylated hemoglobin A

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
if participants meet one of the following criteria they will be excluded.
Descrizione

Criteria Fulfill

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. use of insulin or other pharmaceutical agent for diabetic control other than thiazolidinedione (tzd), sulfonylurea's, or metformin or a combination of medications.
Descrizione

Insulin | Pharmaceutical Preparations Diabetes Mellitus Control | Exception Thiazolidinediones | Exception Sulfonylureas | Exception Metformin | Exception Combined Modality Therapy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0011849
UMLS CUI [2,3]
C0243148
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1257987
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0038766
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0025598
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0009429
2. bmi ≤ 24.9 or ≥ 50.1
Descrizione

Body mass index

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1305855
3. participation in another formal weight loss program within last 6 months
Descrizione

Participation Weight Reduction Program

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C3179079
4. participation in diabetes support and education program or other formal diabetes education program within last 6 months
Descrizione

Participation Diabetic education Program

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0204935
UMLS CUI [1,3]
C3484370
5. uncontrolled hypertension (systolic blood pressure > 180 or diastolic blood pressure > 100 mmhg). participants on medication treating hypertension for at least three months are allowable.
Descrizione

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Pharmacotherapy Hypertensive disease allowed

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C0013216
UMLS CUI [4,2]
C0020538
UMLS CUI [4,3]
C0683607
6. known atherosclerotic cardiovascular disease
Descrizione

Atherosclerosis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0004153
7. history of congestive heart failure
Descrizione

Congestive heart failure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0018802
8. history of a non-skin malignancy within the previous 5 years
Descrizione

Malignant Neoplasms | Exception Skin carcinoma

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
9. any major active rheumatologic, pulmonary, hepatic, renal, dermatologic disease or inflammatory condition
Descrizione

Rheumatologic Disease Major | Lung disease Major | Liver disease Major | Kidney Disease Major | Dermatologic disorder Major | Inflammatory disorder Major

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009326
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C0205164
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0205164
UMLS CUI [4,1]
C0022658
UMLS CUI [4,2]
C0205164
UMLS CUI [5,1]
C0037274
UMLS CUI [5,2]
C0205164
UMLS CUI [6,1]
C1290884
UMLS CUI [6,2]
C0205164
detailed disease and lab value exclusions:
Descrizione

Disease Exclusion Details | Laboratory Results Exclusion Details

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C1522508
UMLS CUI [2,1]
C1254595
UMLS CUI [2,2]
C2828389
UMLS CUI [2,3]
C1522508
active rheumatologic, dermatologic disease, or autoimmune/inflammatory condition will be defined as any patient who currently, or has a past medical history of chronic (> 2 weeks) immune modulating/suppressing medications.
Descrizione

Rheumatologic disorder | Dermatologic disorders | Autoimmune Diseases | Inflammatory disorder | Biological Response Modifiers chronic | Immunosuppressive Agents chronic

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009326
UMLS CUI [2]
C0037274
UMLS CUI [3]
C0004364
UMLS CUI [4]
C1290884
UMLS CUI [5,1]
C0005525
UMLS CUI [5,2]
C0205191
UMLS CUI [6,1]
C0021081
UMLS CUI [6,2]
C0205191
active pulmonary disease will be defined as any patient who has a history of, or currently requires, daily oral corticosteroids, leukotriene inhibitors, an oxygen requirement, or ventilation support for chronic disease management.
Descrizione

Lung disease | Adrenal Cortex Hormones Oral Daily | Leukotriene Antagonists Daily | Oxygen Requirement | Pulmonary Ventilation Support Chronic disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0332173
UMLS CUI [3,1]
C0595726
UMLS CUI [3,2]
C0332173
UMLS CUI [4,1]
C0030054
UMLS CUI [4,2]
C1514873
UMLS CUI [5,1]
C0035213
UMLS CUI [5,2]
C1521721
UMLS CUI [5,3]
C0008679
active hepatic disease: defined as any patient who currently, or has a history of requiring immune modulating/suppressing medications, ammonia lowering medications, or hepatic disease related diet modifications.
Descrizione

Liver disease | Biological Response Modifiers | Immunosuppressive Agents | Pharmaceutical Preparations Ammonia Lowering | Dietary Modification Relationship Liver disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0005525
UMLS CUI [3]
C0021081
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0002607
UMLS CUI [4,3]
C2003888
UMLS CUI [5,1]
C0086153
UMLS CUI [5,2]
C0439849
UMLS CUI [5,3]
C0023895
active renal disease: defined as any patient who currently, or has a history requiring potassium phosphate lowering medications, protein restriction diet, or hemo/peritoneal dialysis.
Descrizione

Kidney Disease | Pharmaceutical Preparations Potassium phosphate Lowering | Diet, Protein-Restricted | Hemodialysis | Peritoneal Dialysis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0071778
UMLS CUI [2,3]
C2003888
UMLS CUI [3]
C0242972
UMLS CUI [4]
C0019004
UMLS CUI [5]
C0031139
lab value exclusions are limited to all routine electrolyte values outside the normal range, except glucose. (sodium, potassium, chloride, bicarbonate, bun, creatinine.)
Descrizione

Laboratory Results Exclusion | Electrolytes abnormal | Exception Glucose | Serum sodium abnormal | Serum potassium abnormal | Serum chloride abnormal | Serum bicarbonate abnormal | Blood urea nitrogen abnormal | Serum creatinine abnormal

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2828389
UMLS CUI [2]
C0151613
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0017725
UMLS CUI [4]
C0858176
UMLS CUI [5]
C0858156
UMLS CUI [6]
C0858098
UMLS CUI [7]
C0858076
UMLS CUI [8]
C0438242
UMLS CUI [9]
C0438243
10. history of testing hiv positive
Descrizione

HIV Seropositivity

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019699
11. history of alcohol or drug abuse
Descrizione

Substance Use Disorders

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0038586
12. weight-loss inducing medications or dietary supplements within 3 months prior to enrollment.
Descrizione

Weight-Loss Agents | Dietary Supplements

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2]
C0242295
13. weight loss > 5 kg during the last 6 months
Descrizione

Weight loss kg Quantity

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439209
UMLS CUI [1,3]
C1265611
14. participation in any weight loss study or investigational drug study within 6 weeks prior to the screening
Descrizione

Study Subject Participation Status | Weight loss | Investigational New Drugs

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1262477
UMLS CUI [3]
C0013230
15. serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
Descrizione

Medical condition Serious compromises Patient safety | Medical condition Unstable compromises Patient safety | Mental condition Serious compromises Patient safety | Mental condition Unstable compromises Patient safety | Medical condition Serious compromises Study Subject Participation Status | Medical condition Unstable compromises Study Subject Participation Status | Mental condition Serious compromises Study Subject Participation Status | Mental condition Unstable compromises Study Subject Participation Status

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C1113679
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C2945640
UMLS CUI [3,4]
C1113679
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0443343
UMLS CUI [4,3]
C2945640
UMLS CUI [4,4]
C1113679
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0205404
UMLS CUI [5,3]
C2945640
UMLS CUI [5,4]
C2348568
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0443343
UMLS CUI [6,3]
C2945640
UMLS CUI [6,4]
C2348568
UMLS CUI [7,1]
C3840291
UMLS CUI [7,2]
C0205404
UMLS CUI [7,3]
C2945640
UMLS CUI [7,4]
C2348568
UMLS CUI [8,1]
C3840291
UMLS CUI [8,2]
C0443343
UMLS CUI [8,3]
C2945640
UMLS CUI [8,4]
C2348568
16. participants with screening triglycerides above 500 mg
Descrizione

Triglycerides measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0202236
17. anyone that is physically active for ≥ 30 minutes per day as assessed in clinical interview at the screening visit
Descrizione

Physical activity mins/day Quantity

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0026606
UMLS CUI [1,2]
C0556973
UMLS CUI [1,3]
C1265611
18. uncontrolled dyslipidemia. participants stable on medication treating dyslipidemia for at least 3 months or more is allowable.
Descrizione

Dyslipidemia Uncontrolled | Pharmacotherapy Stable Dyslipidemia allowed

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0242339
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0242339
UMLS CUI [2,4]
C0683607
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Similar models

Eligibility Type 2 Diabetes NCT00593476

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
participants must meet all of the following criteria.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent | Pregnancy Absent | Breast Feeding Absent | Age
Item
1. type 2 diabetic men and non-pregnant or non-lactating women between the ages of 21 to 75
boolean
C0011860 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
Body mass index
Item
2. bmi ≥ 25 and ≤ 50
boolean
C1305855 (UMLS CUI [1])
Protocol Compliance
Item
3. subjects must be willing to comply with all study-related procedures
boolean
C0525058 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
4. participant with screening hba1c ≥ 6.0
boolean
C0019018 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
if participants meet one of the following criteria they will be excluded.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Insulin | Pharmaceutical Preparations Diabetes Mellitus Control | Exception Thiazolidinediones | Exception Sulfonylureas | Exception Metformin | Exception Combined Modality Therapy
Item
1. use of insulin or other pharmaceutical agent for diabetic control other than thiazolidinedione (tzd), sulfonylurea's, or metformin or a combination of medications.
boolean
C0021641 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
C0243148 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1257987 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0038766 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0025598 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0009429 (UMLS CUI [6,2])
Body mass index
Item
2. bmi ≤ 24.9 or ≥ 50.1
boolean
C1305855 (UMLS CUI [1])
Participation Weight Reduction Program
Item
3. participation in another formal weight loss program within last 6 months
boolean
C0679823 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
Participation Diabetic education Program
Item
4. participation in diabetes support and education program or other formal diabetes education program within last 6 months
boolean
C0679823 (UMLS CUI [1,1])
C0204935 (UMLS CUI [1,2])
C3484370 (UMLS CUI [1,3])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Pharmacotherapy Hypertensive disease allowed
Item
5. uncontrolled hypertension (systolic blood pressure > 180 or diastolic blood pressure > 100 mmhg). participants on medication treating hypertension for at least three months are allowable.
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0013216 (UMLS CUI [4,1])
C0020538 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Atherosclerosis
Item
6. known atherosclerotic cardiovascular disease
boolean
C0004153 (UMLS CUI [1])
Congestive heart failure
Item
7. history of congestive heart failure
boolean
C0018802 (UMLS CUI [1])
Malignant Neoplasms | Exception Skin carcinoma
Item
8. history of a non-skin malignancy within the previous 5 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Rheumatologic Disease Major | Lung disease Major | Liver disease Major | Kidney Disease Major | Dermatologic disorder Major | Inflammatory disorder Major
Item
9. any major active rheumatologic, pulmonary, hepatic, renal, dermatologic disease or inflammatory condition
boolean
C0009326 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0022658 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0037274 (UMLS CUI [5,1])
C0205164 (UMLS CUI [5,2])
C1290884 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
Disease Exclusion Details | Laboratory Results Exclusion Details
Item
detailed disease and lab value exclusions:
boolean
C0012634 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C1254595 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C1522508 (UMLS CUI [2,3])
Rheumatologic disorder | Dermatologic disorders | Autoimmune Diseases | Inflammatory disorder | Biological Response Modifiers chronic | Immunosuppressive Agents chronic
Item
active rheumatologic, dermatologic disease, or autoimmune/inflammatory condition will be defined as any patient who currently, or has a past medical history of chronic (> 2 weeks) immune modulating/suppressing medications.
boolean
C0009326 (UMLS CUI [1])
C0037274 (UMLS CUI [2])
C0004364 (UMLS CUI [3])
C1290884 (UMLS CUI [4])
C0005525 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
C0021081 (UMLS CUI [6,1])
C0205191 (UMLS CUI [6,2])
Lung disease | Adrenal Cortex Hormones Oral Daily | Leukotriene Antagonists Daily | Oxygen Requirement | Pulmonary Ventilation Support Chronic disease
Item
active pulmonary disease will be defined as any patient who has a history of, or currently requires, daily oral corticosteroids, leukotriene inhibitors, an oxygen requirement, or ventilation support for chronic disease management.
boolean
C0024115 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0332173 (UMLS CUI [2,3])
C0595726 (UMLS CUI [3,1])
C0332173 (UMLS CUI [3,2])
C0030054 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0035213 (UMLS CUI [5,1])
C1521721 (UMLS CUI [5,2])
C0008679 (UMLS CUI [5,3])
Liver disease | Biological Response Modifiers | Immunosuppressive Agents | Pharmaceutical Preparations Ammonia Lowering | Dietary Modification Relationship Liver disease
Item
active hepatic disease: defined as any patient who currently, or has a history of requiring immune modulating/suppressing medications, ammonia lowering medications, or hepatic disease related diet modifications.
boolean
C0023895 (UMLS CUI [1])
C0005525 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0002607 (UMLS CUI [4,2])
C2003888 (UMLS CUI [4,3])
C0086153 (UMLS CUI [5,1])
C0439849 (UMLS CUI [5,2])
C0023895 (UMLS CUI [5,3])
Kidney Disease | Pharmaceutical Preparations Potassium phosphate Lowering | Diet, Protein-Restricted | Hemodialysis | Peritoneal Dialysis
Item
active renal disease: defined as any patient who currently, or has a history requiring potassium phosphate lowering medications, protein restriction diet, or hemo/peritoneal dialysis.
boolean
C0022658 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0071778 (UMLS CUI [2,2])
C2003888 (UMLS CUI [2,3])
C0242972 (UMLS CUI [3])
C0019004 (UMLS CUI [4])
C0031139 (UMLS CUI [5])
Laboratory Results Exclusion | Electrolytes abnormal | Exception Glucose | Serum sodium abnormal | Serum potassium abnormal | Serum chloride abnormal | Serum bicarbonate abnormal | Blood urea nitrogen abnormal | Serum creatinine abnormal
Item
lab value exclusions are limited to all routine electrolyte values outside the normal range, except glucose. (sodium, potassium, chloride, bicarbonate, bun, creatinine.)
boolean
C1254595 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0151613 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0017725 (UMLS CUI [3,2])
C0858176 (UMLS CUI [4])
C0858156 (UMLS CUI [5])
C0858098 (UMLS CUI [6])
C0858076 (UMLS CUI [7])
C0438242 (UMLS CUI [8])
C0438243 (UMLS CUI [9])
HIV Seropositivity
Item
10. history of testing hiv positive
boolean
C0019699 (UMLS CUI [1])
Substance Use Disorders
Item
11. history of alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Weight-Loss Agents | Dietary Supplements
Item
12. weight-loss inducing medications or dietary supplements within 3 months prior to enrollment.
boolean
C0376606 (UMLS CUI [1])
C0242295 (UMLS CUI [2])
Weight loss kg Quantity
Item
13. weight loss > 5 kg during the last 6 months
boolean
C1262477 (UMLS CUI [1,1])
C0439209 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Study Subject Participation Status | Weight loss | Investigational New Drugs
Item
14. participation in any weight loss study or investigational drug study within 6 weeks prior to the screening
boolean
C2348568 (UMLS CUI [1])
C1262477 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Medical condition Serious compromises Patient safety | Medical condition Unstable compromises Patient safety | Mental condition Serious compromises Patient safety | Mental condition Unstable compromises Patient safety | Medical condition Serious compromises Study Subject Participation Status | Medical condition Unstable compromises Study Subject Participation Status | Mental condition Serious compromises Study Subject Participation Status | Mental condition Unstable compromises Study Subject Participation Status
Item
15. serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C3840291 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C2945640 (UMLS CUI [3,3])
C1113679 (UMLS CUI [3,4])
C3840291 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C2945640 (UMLS CUI [4,3])
C1113679 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C2945640 (UMLS CUI [5,3])
C2348568 (UMLS CUI [5,4])
C3843040 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C2945640 (UMLS CUI [6,3])
C2348568 (UMLS CUI [6,4])
C3840291 (UMLS CUI [7,1])
C0205404 (UMLS CUI [7,2])
C2945640 (UMLS CUI [7,3])
C2348568 (UMLS CUI [7,4])
C3840291 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
C2945640 (UMLS CUI [8,3])
C2348568 (UMLS CUI [8,4])
Triglycerides measurement
Item
16. participants with screening triglycerides above 500 mg
boolean
C0202236 (UMLS CUI [1])
Physical activity mins/day Quantity
Item
17. anyone that is physically active for ≥ 30 minutes per day as assessed in clinical interview at the screening visit
boolean
C0026606 (UMLS CUI [1,1])
C0556973 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Dyslipidemia Uncontrolled | Pharmacotherapy Stable Dyslipidemia allowed
Item
18. uncontrolled dyslipidemia. participants stable on medication treating dyslipidemia for at least 3 months or more is allowable.
boolean
C0242339 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0013216 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0242339 (UMLS CUI [2,3])
C0683607 (UMLS CUI [2,4])
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