ID

42360

Description

Weight Loss Study for People With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01601574

Link

https://clinicaltrials.gov/show/NCT01601574

Keywords

Versions (2)
  1. 6/20/21 6/20/21 -
  2. 6/23/21 6/23/21 -
Copyright Holder

Medical University of South Carolina

Uploaded on

June 23, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Weight Loss NCT01601574

English

Eligibility Type 2 Diabetes Weight Loss NCT01601574

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. participant reported diagnosis of type ii diabetes
Description

Type 2 diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011860
2. hba1c between 7 ‐ 11 percent (inclusive)
Description

HbA1c

Data type

boolean

Alias
UMLS CUI [1]
C0474680
3. fasting blood glucose < 240. if a potential participant has a fbg above the inclusion criteria it is acceptable to re‐test this potential participant within one week of the original test.
Description

Fasting blood glucose

Data type

boolean

Alias
UMLS CUI [1]
C0428568
4. bmi 27‐50 kg/m2 (inclusive)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
5. age range - 18 - 70 (inclusive)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
6. clearance on medical exam by study physician including ekg
Description

Medical clearance clinical investigator | incl. EKG

Data type

boolean

Alias
UMLS CUI [1,1]
C4483684
UMLS CUI [1,2]
C0008961
UMLS CUI [2]
C1623258
7. no weight loss over the previous 3 months (5kg loss is acceptable with physician discretion)
Description

No recent weight loss

Data type

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0332185
8. and 9. on stable regimen of all medications (including diabetes) for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted, all diabetes medications are permitted including insulin.)
Description

Stable status of all recent medication regimens

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0332185
10. willing and able to commit to regular physical activity (e.g. walking) five days per week
Description

Willingness and ability to commit to regular physical activity

Data type

boolean

Alias
UMLS CUI [1,1]
C0024501
UMLS CUI [1,2]
C0026606
UMLS CUI [1,3]
C0205272
UMLS CUI [1,4]
C0600109
UMLS CUI [2,1]
C0024501
UMLS CUI [2,2]
C0026606
UMLS CUI [2,3]
C0205272
UMLS CUI [2,4]
C0085732
11. willingness and ability to make all scheduled appointments required by study protocol
Description

Willingness and ability to study protocol compliance w.r.t. scheduled appointments

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0030675
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0030675
UMLS CUI [2,3]
C0085732
12. willingness to attend weekly weight watchers meetings in the community and to participate in weight watchers online program, if so randomized
Description

Willingness to participate in weight watchers program

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C3179079
UMLS CUI [1,3]
C0600109
13. willing to follow requirements of study protocol
Description

Willingness to comply with study protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C0525058
14. willing and able to provide a valid email address for use in the study
Description

Willingness and ability to provide email address

Data type

boolean

Alias
UMLS CUI [1,1]
C1705961
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C1705961
UMLS CUI [2,2]
C0085732
15. must be able to communicate (oral and written) in english
Description

Able to communicate in English

Data type

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0376245
16. under the care of a physician for diabetes and willing to give release to contact the md and request md's agreement for participant to participate -
Description

Under the care of a physician for diabetes | willing to provide contact to MD | MD agrees to study participation

Data type

boolean

Alias
UMLS CUI [1,1]
C0583348
UMLS CUI [1,2]
C0011849
UMLS CUI [2,1]
C1880174
UMLS CUI [2,2]
C0033131
UMLS CUI [2,3]
C1999230
UMLS CUI [2,4]
C0600109
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C0033131
UMLS CUI [3,3]
C0680240
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. type 1 diabetes
Description

Type 1 diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011854
2. cardiovascular/coronary heart disease [e.g., mi or cva within last 6 months, tia, clinically significant arrhythmias, uncontrolled hypertension (defined as blood pressure over 160/110); physician's discretion may be more conservative]
Description

Cardiovascular disease | coronary heart disease | recent mi or cva | tia | clinically significant arrhythmias | uncontrolled hypertension determined by blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0010068
UMLS CUI [3,1]
C0027051
UMLS CUI [3,2]
C0332185
UMLS CUI [4,1]
C0038454
UMLS CUI [4,2]
C0332185
UMLS CUI [5]
C0007787
UMLS CUI [6,1]
C0003811
UMLS CUI [6,2]
C2985739
UMLS CUI [7,1]
C0020538
UMLS CUI [7,2]
C0205318
UMLS CUI [8]
C0005824
3. current severe depression or history of severe depression within the previous year, based on dsm‐iv‐tr criteria for major depressive episode
Description

Current severe depression | severe depression within previous year | based on dsm‐iv‐tr criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0521116
UMLS CUI [2,1]
C0011581
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C3887293
UMLS CUI [3,1]
C0220952
UMLS CUI [3,2]
C1269683
4. taking prescription or otc weight loss medications within last 4 weeks
Description

Weight loss medication prescribed recent | Weight loss medication otc recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0376606
UMLS CUI [1,2]
C0278329
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0376606
UMLS CUI [2,2]
C0013231
UMLS CUI [2,3]
C0332185
5. currently taking other medications that affect weight (e.g., paroxetine, tricyclics, anti‐psychotics)
Description

Currently on medication that affect weight | paroxetine | tricyclics | anti‐psychotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521116
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0005910
UMLS CUI [2,1]
C0070122
UMLS CUI [2,2]
C0521116
UMLS CUI [3,1]
C0003290
UMLS CUI [3,2]
C0521116
UMLS CUI [4,1]
C0040615
UMLS CUI [4,2]
C0521116
6. within the last 4 weeks, use of chromium supplements or any nutrition supplements or herbal products claimed to have a weight loss effect. participants using other non‐excluded nutrition supplements or herbal products must agree to continue at their current level of use throughout the study.
Description

Recent use of chromium supplements or nutrition supplements or herbal products as weight-loss agent | agreement to dietary supplement continuation

Data type

boolean

Alias
UMLS CUI [1,1]
C0376606
UMLS CUI [1,2]
C3661602
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0376606
UMLS CUI [2,2]
C0242295
UMLS CUI [2,3]
C0332185
UMLS CUI [3,1]
C0376606
UMLS CUI [3,2]
C1572271
UMLS CUI [3,3]
C0332185
UMLS CUI [4,1]
C0680240
UMLS CUI [4,2]
C0242295
UMLS CUI [4,3]
C1265611
7. participation in a weight control program within the past 3 months
Description

Recent participation in weight control program

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C3179079
UMLS CUI [1,3]
C0332185
8. qtc interval >450 msec for males and qtc interval >470 msec for females
Description

Prolonged QTc interval

Data type

boolean

Alias
UMLS CUI [1]
C1560305
9. phq‐9 total score > 15
Description

PHQ‐9 total score

Data type

boolean

Alias
UMLS CUI [1]
C3828565
10. thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. history of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable
Description

Thyroid disease untreated or with treatment changes in past 6 months | Except for thyroid disease with stable medication status

Data type

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0040128
UMLS CUI [2,2]
C1299575
UMLS CUI [2,3]
C3828652
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0040128
UMLS CUI [3,3]
C0237125
UMLS CUI [3,4]
C0205360
11. history of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by‐pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve)
Description

Surgical bariatric procedure | gastroplasty | gastric bypass | gastrectomy or partial gastrectomy | adjustable banding | gastric sleeve

Data type

boolean

Alias
UMLS CUI [1]
C1456587
UMLS CUI [2]
C0017193
UMLS CUI [3]
C0017125
UMLS CUI [4]
C0017118
UMLS CUI [5,1]
C0017118
UMLS CUI [5,2]
C0728938
UMLS CUI [6]
C1719687
UMLS CUI [7]
C3160799
12. history of major surgery within three months of enrollment
Description

Major surgery recent | post enrollment

Data type

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C1516879
13. presence of implanted cardiac defibrillator
Description

Implanted cardiac defibrillator

Data type

boolean

Alias
UMLS CUI [1]
C0850291
14. orthopedic limitations that would interfere with ability to engage in regular physical activity
Description

Orthopedic limitations interfering with ability of physical activity

Data type

boolean

Alias
UMLS CUI [1,1]
C0029354
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0085732
UMLS CUI [1,4]
C0026606
15. gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, crohn's disease, chronic diarrhea or active gallbladder disease
Description

Gastrointestinal disorders | chronic malabsorptive conditions | peptic ulcer disease | crohn's disease | chronic diarrhea | active gallbladder disease

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2,1]
C0024523
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0030920
UMLS CUI [4]
C0010346
UMLS CUI [5,1]
C0011991
UMLS CUI [5,2]
C0205191
UMLS CUI [6]
C0016977
16. current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. persons with successfully resected basal cell carcinoma of the skin may be enrolled if treatment was completed more than 6 months prior to enrollment.
Description

Malign neoplasm | cancer treatment | exception basal cell carcinoma skin resected procedure successful

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0920425
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1123023
UMLS CUI [3,4]
C1521996
UMLS CUI [3,5]
C3258067
17. history, within the past five years, of clinically diagnosed eating disorders confidential march 30, 2012 9 including anorexia nervosa or bulimia nervosa.
Description

Eating disorder | anorexia nervosa | bulimia nervosa

Data type

boolean

Alias
UMLS CUI [1]
C0013473
UMLS CUI [2]
C0003125
UMLS CUI [3]
C2267227
18. women who are pregnant, lactating , trying to become pregnant or unwilling to use an effective means of birth control
Description

Pregnancy | breast feeding | pregnancy intent | unwilling to use birth control

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0162425
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0558080
19. participation in another clinical trial within 30 days prior to enrollment.
Description

Recent participation in another clinical trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
20. currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to limit intake to less than 3 drinks per drinking day during study participation
Description

Alcohol units per week | unwilling to limit alcohol units per day

Data type

boolean

Alias
UMLS CUI [1]
C0560579
UMLS CUI [2,1]
C0439801
UMLS CUI [2,2]
C0560578
UMLS CUI [2,3]
C0558080
21. current or past drug abuse
Description

Drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0013146
22. participation in trial by another member of household
Description

Study subject participation status household member

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C4330269
23. hypoglycemic events: a. evidence of more than 1 severe hypoglycemic event in the past 12 months, unless the participant's treating physician provides written clearance for participation.
Description

Recurrent severe hypoglycemic events | unless treating physician provides clearance for participation

Data type

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2945760
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0205540
UMLS CUI [2,4]
C0033131
24. any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial -
Description

Other medical condition study subject participation status ineligible

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1512714
UMLS CUI [1,5]
C0022423
UMLS CUI [1,6]
C0008961
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Similar models

Eligibility Type 2 Diabetes Weight Loss NCT01601574

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Type 2 diabetes
Item
1. participant reported diagnosis of type ii diabetes
boolean
C0011860 (UMLS CUI [1])
HbA1c
Item
2. hba1c between 7 ‐ 11 percent (inclusive)
boolean
C0474680 (UMLS CUI [1])
Fasting blood glucose
Item
3. fasting blood glucose < 240. if a potential participant has a fbg above the inclusion criteria it is acceptable to re‐test this potential participant within one week of the original test.
boolean
C0428568 (UMLS CUI [1])
Body mass index
Item
4. bmi 27‐50 kg/m2 (inclusive)
boolean
C1305855 (UMLS CUI [1])
Age
Item
5. age range - 18 - 70 (inclusive)
boolean
C0001779 (UMLS CUI [1])
Medical clearance clinical investigator | incl. EKG
Item
6. clearance on medical exam by study physician including ekg
boolean
C4483684 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2])
No recent weight loss
Item
7. no weight loss over the previous 3 months (5kg loss is acceptable with physician discretion)
boolean
C1262477 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Stable status of all recent medication regimens
Item
8. and 9. on stable regimen of all medications (including diabetes) for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted, all diabetes medications are permitted including insulin.)
boolean
C0013227 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Willingness and ability to commit to regular physical activity
Item
10. willing and able to commit to regular physical activity (e.g. walking) five days per week
boolean
C0024501 (UMLS CUI [1,1])
C0026606 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
C0600109 (UMLS CUI [1,4])
C0024501 (UMLS CUI [2,1])
C0026606 (UMLS CUI [2,2])
C0205272 (UMLS CUI [2,3])
C0085732 (UMLS CUI [2,4])
Willingness and ability to study protocol compliance w.r.t. scheduled appointments
Item
11. willingness and ability to make all scheduled appointments required by study protocol
boolean
C0525058 (UMLS CUI [1,1])
C0030675 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C0030675 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Willingness to participate in weight watchers program
Item
12. willingness to attend weekly weight watchers meetings in the community and to participate in weight watchers online program, if so randomized
boolean
C0679823 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Willingness to comply with study protocol
Item
13. willing to follow requirements of study protocol
boolean
C0600109 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
Willingness and ability to provide email address
Item
14. willing and able to provide a valid email address for use in the study
boolean
C1705961 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C1705961 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
Able to communicate in English
Item
15. must be able to communicate (oral and written) in english
boolean
C2364293 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Under the care of a physician for diabetes | willing to provide contact to MD | MD agrees to study participation
Item
16. under the care of a physician for diabetes and willing to give release to contact the md and request md's agreement for participant to participate -
boolean
C0583348 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C1880174 (UMLS CUI [2,1])
C0033131 (UMLS CUI [2,2])
C1999230 (UMLS CUI [2,3])
C0600109 (UMLS CUI [2,4])
C2348568 (UMLS CUI [3,1])
C0033131 (UMLS CUI [3,2])
C0680240 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Type 1 diabetes
Item
1. type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Cardiovascular disease | coronary heart disease | recent mi or cva | tia | clinically significant arrhythmias | uncontrolled hypertension determined by blood pressure
Item
2. cardiovascular/coronary heart disease [e.g., mi or cva within last 6 months, tia, clinically significant arrhythmias, uncontrolled hypertension (defined as blood pressure over 160/110); physician's discretion may be more conservative]
boolean
C0007222 (UMLS CUI [1])
C0010068 (UMLS CUI [2])
C0027051 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0038454 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
C0007787 (UMLS CUI [5])
C0003811 (UMLS CUI [6,1])
C2985739 (UMLS CUI [6,2])
C0020538 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C0005824 (UMLS CUI [8])
Current severe depression | severe depression within previous year | based on dsm‐iv‐tr criteria
Item
3. current severe depression or history of severe depression within the previous year, based on dsm‐iv‐tr criteria for major depressive episode
boolean
C0011581 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C0011581 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C3887293 (UMLS CUI [2,3])
C0220952 (UMLS CUI [3,1])
C1269683 (UMLS CUI [3,2])
Weight loss medication prescribed recent | Weight loss medication otc recent
Item
4. taking prescription or otc weight loss medications within last 4 weeks
boolean
C0376606 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0376606 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Currently on medication that affect weight | paroxetine | tricyclics | anti‐psychotics
Item
5. currently taking other medications that affect weight (e.g., paroxetine, tricyclics, anti‐psychotics)
boolean
C0013227 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0005910 (UMLS CUI [1,4])
C0070122 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C0003290 (UMLS CUI [3,1])
C0521116 (UMLS CUI [3,2])
C0040615 (UMLS CUI [4,1])
C0521116 (UMLS CUI [4,2])
Recent use of chromium supplements or nutrition supplements or herbal products as weight-loss agent | agreement to dietary supplement continuation
Item
6. within the last 4 weeks, use of chromium supplements or any nutrition supplements or herbal products claimed to have a weight loss effect. participants using other non‐excluded nutrition supplements or herbal products must agree to continue at their current level of use throughout the study.
boolean
C0376606 (UMLS CUI [1,1])
C3661602 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0376606 (UMLS CUI [2,1])
C0242295 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C0376606 (UMLS CUI [3,1])
C1572271 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0680240 (UMLS CUI [4,1])
C0242295 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Recent participation in weight control program
Item
7. participation in a weight control program within the past 3 months
boolean
C0679823 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Prolonged QTc interval
Item
8. qtc interval >450 msec for males and qtc interval >470 msec for females
boolean
C1560305 (UMLS CUI [1])
PHQ‐9 total score
Item
9. phq‐9 total score > 15
boolean
C3828565 (UMLS CUI [1])
Thyroid disease untreated or with treatment changes in past 6 months | Except for thyroid disease with stable medication status
Item
10. thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. history of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable
boolean
C0040128 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0040128 (UMLS CUI [2,1])
C1299575 (UMLS CUI [2,2])
C3828652 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0040128 (UMLS CUI [3,2])
C0237125 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
Surgical bariatric procedure | gastroplasty | gastric bypass | gastrectomy or partial gastrectomy | adjustable banding | gastric sleeve
Item
11. history of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by‐pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve)
boolean
C1456587 (UMLS CUI [1])
C0017193 (UMLS CUI [2])
C0017125 (UMLS CUI [3])
C0017118 (UMLS CUI [4])
C0017118 (UMLS CUI [5,1])
C0728938 (UMLS CUI [5,2])
C1719687 (UMLS CUI [6])
C3160799 (UMLS CUI [7])
Major surgery recent | post enrollment
Item
12. history of major surgery within three months of enrollment
boolean
C0679637 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0679637 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1516879 (UMLS CUI [2,3])
Implanted cardiac defibrillator
Item
13. presence of implanted cardiac defibrillator
boolean
C0850291 (UMLS CUI [1])
Orthopedic limitations interfering with ability of physical activity
Item
14. orthopedic limitations that would interfere with ability to engage in regular physical activity
boolean
C0029354 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0026606 (UMLS CUI [1,4])
Gastrointestinal disorders | chronic malabsorptive conditions | peptic ulcer disease | crohn's disease | chronic diarrhea | active gallbladder disease
Item
15. gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, crohn's disease, chronic diarrhea or active gallbladder disease
boolean
C0017178 (UMLS CUI [1])
C0024523 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0030920 (UMLS CUI [3])
C0010346 (UMLS CUI [4])
C0011991 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
C0016977 (UMLS CUI [6])
Malign neoplasm | cancer treatment | exception basal cell carcinoma skin resected procedure successful
Item
16. current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. persons with successfully resected basal cell carcinoma of the skin may be enrolled if treatment was completed more than 6 months prior to enrollment.
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1123023 (UMLS CUI [3,3])
C1521996 (UMLS CUI [3,4])
C3258067 (UMLS CUI [3,5])
Eating disorder | anorexia nervosa | bulimia nervosa
Item
17. history, within the past five years, of clinically diagnosed eating disorders confidential march 30, 2012 9 including anorexia nervosa or bulimia nervosa.
boolean
C0013473 (UMLS CUI [1])
C0003125 (UMLS CUI [2])
C2267227 (UMLS CUI [3])
Pregnancy | breast feeding | pregnancy intent | unwilling to use birth control
Item
18. women who are pregnant, lactating , trying to become pregnant or unwilling to use an effective means of birth control
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0162425 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
Recent participation in another clinical trial
Item
19. participation in another clinical trial within 30 days prior to enrollment.
boolean
C2348568 (UMLS CUI [1])
Alcohol units per week | unwilling to limit alcohol units per day
Item
20. currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to limit intake to less than 3 drinks per drinking day during study participation
boolean
C0560579 (UMLS CUI [1])
C0439801 (UMLS CUI [2,1])
C0560578 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Drug abuse
Item
21. current or past drug abuse
boolean
C0013146 (UMLS CUI [1])
Study subject participation status household member
Item
22. participation in trial by another member of household
boolean
C2348568 (UMLS CUI [1,1])
C4330269 (UMLS CUI [1,2])
Recurrent severe hypoglycemic events | unless treating physician provides clearance for participation
Item
23. hypoglycemic events: a. evidence of more than 1 severe hypoglycemic event in the past 12 months, unless the participant's treating physician provides written clearance for participation.
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945760 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0205540 (UMLS CUI [2,3])
C0033131 (UMLS CUI [2,4])
Other medical condition study subject participation status ineligible
Item
24. any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial -
boolean
C0012634 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1512714 (UMLS CUI [1,4])
C0022423 (UMLS CUI [1,5])
C0008961 (UMLS CUI [1,6])
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