ID

39001

Description

Novel Type 2 Diabetes Mellitus Preventive Therapies; ODM derived from: https://clinicaltrials.gov/show/NCT02351323

Link

https://clinicaltrials.gov/show/NCT02351323

Keywords

Versions (1)
  1. 11/19/19 11/19/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 19, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT02351323

English

Eligibility Diabetes NCT02351323

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02351323
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. bmi (k/m2) >= 95th percentile;
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
2. weight 150 - 400 pounds;
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
3. language: english or spanish (the pi speaks both english and spanish fluently).
Description

Language ability English Language | Language ability Spanish Language

Data type

boolean

Alias
UMLS CUI [1,1]
C1145677
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C1145677
UMLS CUI [2,2]
C0037750
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of t2dm;
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
2. prior or current drug treatmeant that would effect diabetes risk
Description

Pharmacotherapy Effect Diabetes risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C1171304
3. use of prescription strength glucocorticoids within three months before screening,
Description

Glucocorticoids Prescription

Data type

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C0033080
4. history of syndrome or medical disorder associated with significant obesity;
Description

Syndrome Associated with Obesity | Disease Associated with Obesity

Data type

boolean

Alias
UMLS CUI [1,1]
C0039082
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0028754
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0028754
5. serum creatinine >1.2 mg/dl;
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
6. alanine transaminase (alt) or aspartate aminotransferase (ast) >90 international units (iu)/l (= 3 x normal limits);
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
7. total bilirubin >2.5 time the upper limit of normal;
Description

Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0741494
8. history of moderate to extreme physical activity, past or current pregnancy;
Description

Moderate physical activity | Physical activity Extreme | Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C4482418
UMLS CUI [2,1]
C0026606
UMLS CUI [2,2]
C0205403
UMLS CUI [3]
C0032961
9 .use of illegal/illicit drugs;
Description

Illicit medication use

Data type

boolean

Alias
UMLS CUI [1]
C0281875
10. unable to comply with the protocol;
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
11. any other serious disease determined by the clinician as potential study risk for the patient.
Description

Disease Serious Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1444641
12. have kidney or liver disorders, or conditions resulting in ammonia accumulation
Description

Kidney Diseases | Liver diseases | Condition Resulting in Ammonia Accumulation

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0332294
UMLS CUI [3,3]
C0002607
UMLS CUI [3,4]
C4055506
13. take lactulose
Description

Lactulose

Data type

boolean

Alias
UMLS CUI [1]
C0022957
14. are allergic to monosodium glutamate (msg), glutamine, or crystal light
Description

Hypersensitivity Sodium Glutamate | Hypersensitivity Glutamine | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0037511
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0017797
UMLS CUI [3]
C3846158
15. have manic episodes (mental illness)
Description

Manic episodes

Data type

boolean

Alias
UMLS CUI [1]
C0349208
16. take medications to prevent seizures
Description

Anticonvulsant therapy

Data type

boolean

Alias
UMLS CUI [1]
C0521306
17. take any glutamine, supplement with glutamine, hypoglycemiants, anticonvulsivant, adhd medications, antilipidemiants, or thyroid hormone
Description

Glutamine | Glutamine Supplements | Hypoglycemic Agents | Anticonvulsants | Pharmaceutical Preparations Attention deficit hyperactivity disorder | Antilipidemic Agent | Thyroid Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0017797
UMLS CUI [2,1]
C0017797
UMLS CUI [2,2]
C0242295
UMLS CUI [3]
C0020616
UMLS CUI [4]
C0003286
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C1263846
UMLS CUI [6]
C1516000
UMLS CUI [7]
C0040135
18. participation in a weight loss program or use of weight loss medications within six months of screening that has resulted in 5% or more weight loss
Description

Participation Weight Reduction Programs | Weight-Loss Agents | Weight loss Percentage Timespan

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C3179079
UMLS CUI [2]
C0376606
UMLS CUI [3,1]
C1262477
UMLS CUI [3,2]
C0439165
UMLS CUI [3,3]
C0872291
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Similar models

Eligibility Diabetes NCT02351323

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02351323
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
1. bmi (k/m2) >= 95th percentile;
boolean
C1305855 (UMLS CUI [1])
Body Weight
Item
2. weight 150 - 400 pounds;
boolean
C0005910 (UMLS CUI [1])
Language ability English Language | Language ability Spanish Language
Item
3. language: english or spanish (the pi speaks both english and spanish fluently).
boolean
C1145677 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C1145677 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
1. history of t2dm;
boolean
C0011860 (UMLS CUI [1])
Pharmacotherapy Effect Diabetes risk
Item
2. prior or current drug treatmeant that would effect diabetes risk
boolean
C0013216 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C1171304 (UMLS CUI [1,3])
Glucocorticoids Prescription
Item
3. use of prescription strength glucocorticoids within three months before screening,
boolean
C0017710 (UMLS CUI [1,1])
C0033080 (UMLS CUI [1,2])
Syndrome Associated with Obesity | Disease Associated with Obesity
Item
4. history of syndrome or medical disorder associated with significant obesity;
boolean
C0039082 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0028754 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0028754 (UMLS CUI [2,3])
Creatinine measurement, serum
Item
5. serum creatinine >1.2 mg/dl;
boolean
C0201976 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
6. alanine transaminase (alt) or aspartate aminotransferase (ast) >90 international units (iu)/l (= 3 x normal limits);
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Elevated total bilirubin
Item
7. total bilirubin >2.5 time the upper limit of normal;
boolean
C0741494 (UMLS CUI [1])
Moderate physical activity | Physical activity Extreme | Pregnancy
Item
8. history of moderate to extreme physical activity, past or current pregnancy;
boolean
C4482418 (UMLS CUI [1])
C0026606 (UMLS CUI [2,1])
C0205403 (UMLS CUI [2,2])
C0032961 (UMLS CUI [3])
Illicit medication use
Item
9 .use of illegal/illicit drugs;
boolean
C0281875 (UMLS CUI [1])
Protocol Compliance Unable
Item
10. unable to comply with the protocol;
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Disease Serious Study Subject Participation Status At risk
Item
11. any other serious disease determined by the clinician as potential study risk for the patient.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])
Kidney Diseases | Liver diseases | Condition Resulting in Ammonia Accumulation
Item
12. have kidney or liver disorders, or conditions resulting in ammonia accumulation
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C0332294 (UMLS CUI [3,2])
C0002607 (UMLS CUI [3,3])
C4055506 (UMLS CUI [3,4])
Lactulose
Item
13. take lactulose
boolean
C0022957 (UMLS CUI [1])
Hypersensitivity Sodium Glutamate | Hypersensitivity Glutamine | Other Coding
Item
14. are allergic to monosodium glutamate (msg), glutamine, or crystal light
boolean
C0020517 (UMLS CUI [1,1])
C0037511 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0017797 (UMLS CUI [2,2])
C3846158 (UMLS CUI [3])
Manic episodes
Item
15. have manic episodes (mental illness)
boolean
C0349208 (UMLS CUI [1])
Anticonvulsant therapy
Item
16. take medications to prevent seizures
boolean
C0521306 (UMLS CUI [1])
Glutamine | Glutamine Supplements | Hypoglycemic Agents | Anticonvulsants | Pharmaceutical Preparations Attention deficit hyperactivity disorder | Antilipidemic Agent | Thyroid Hormones
Item
17. take any glutamine, supplement with glutamine, hypoglycemiants, anticonvulsivant, adhd medications, antilipidemiants, or thyroid hormone
boolean
C0017797 (UMLS CUI [1])
C0017797 (UMLS CUI [2,1])
C0242295 (UMLS CUI [2,2])
C0020616 (UMLS CUI [3])
C0003286 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C1263846 (UMLS CUI [5,2])
C1516000 (UMLS CUI [6])
C0040135 (UMLS CUI [7])
Participation Weight Reduction Programs | Weight-Loss Agents | Weight loss Percentage Timespan
Item
18. participation in a weight loss program or use of weight loss medications within six months of screening that has resulted in 5% or more weight loss
boolean
C0679823 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
C0376606 (UMLS CUI [2])
C1262477 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0872291 (UMLS CUI [3,3])
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