ID

23422

Beschreibung

Targeting INflammation Using SALsalate in Type 2 Diabetes (TINSAL-T2D); ODM derived from: https://clinicaltrials.gov/show/NCT00392678

Link

https://clinicaltrials.gov/show/NCT00392678

Stichworte

Versionen (1)
  1. 04.07.17 04.07.17 -
Hochgeladen am

4. Juli 2017

DOI

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Lizenz

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Eligibility Type 2 Diabetes NCT00392678

Englisch

Eligibility Type 2 Diabetes NCT00392678

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. type 2 diabetes on diet and exercise therapy or monotherapy with metformin, insulin secretagogue, or alpha-glucosidase inhibitors, or a low-dose combination of these at
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise regime | Metformin | Insulin | alpha-Glucosidase Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0454291
UMLS CUI [4]
C0025598
UMLS CUI [5]
C0021641
UMLS CUI [6]
C1299007
≤ 50% maximal dose (see appendix). dosing is stable for 8 weeks prior to randomization.
Beschreibung

Combined Modality Therapy Low dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C0445550
UMLS CUI [1,3]
C0205360
2. fpg ≤ 225 mg/dl and hba1c>7% and ≤9.5% at screening
Beschreibung

Plasma fasting glucose measurement | Glycosylated hemoglobin A

Datentyp

boolean

Alias
UMLS CUI [1]
C0583513
UMLS CUI [2]
C0019018
3. age ≥18 and <75
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. women of childbearing potential agree to use an appropriate contraceptive method (hormonal, iud, or diaphragm)
Beschreibung

Childbearing Potential Contraceptive methods | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C2985296
UMLS CUI [3]
C0021900
UMLS CUI [4]
C0042241
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. type 1 diabetes and/or history of ketoacidosis determined by medical history
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Ketoacidosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0220982
2. history of severe diabetic neuropathy including autonomic neuropathy, gastroparesis or lower limb ulceration or amputation
Beschreibung

Diabetic Neuropathy Severe | Autonomic neuropathy | Gastroparesis | Leg Ulcer | Amputation of lower limb

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011882
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0259749
UMLS CUI [3]
C0152020
UMLS CUI [4]
C0023223
UMLS CUI [5]
C0337308
3. history of long-term therapy with insulin (>30 days) within the last year
Beschreibung

Insulin Long-term

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0443252
4. therapy with rosiglitazone (avandia) or pioglitazone (actos), or extendin-4 (byetta), alone or in combination in the previous 6 months
Beschreibung

rosiglitazone | Avandia | pioglitazone | Actos | exenatide | Byetta | Combined Modality Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0289313
UMLS CUI [2]
C0875967
UMLS CUI [3]
C0071097
UMLS CUI [4]
C0875954
UMLS CUI [5]
C0167117
UMLS CUI [6]
C1636686
UMLS CUI [7]
C0009429
5. pregnancy or lactation
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
6. patients requiring corticosteroids within 3 months or recurrent continuous oral corticosteroid treatment (more than 2 weeks)
Beschreibung

Adrenal Cortex Hormones | Adrenal Cortex Hormones Oral Recurrent

Datentyp

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C2945760
7. use of weight loss drugs [e.g., xenical (orlistat), meridia (sibutramine), acutrim (phenylpropanol-amine), or similar over-the-counter medications] within 3 months of screening or intentional weight loss of ≥ 10 lbs in the previous 6 months
Beschreibung

Weight-Loss Agents | Xenical | orlistat | Meridia | sibutramine | Phenylpropanolamine | Non-Prescription Drugs Similar | Intentional weight loss

Datentyp

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2]
C0732649
UMLS CUI [3]
C0076275
UMLS CUI [4]
C0635898
UMLS CUI [5]
C0074493
UMLS CUI [6]
C0031495
UMLS CUI [7,1]
C0013231
UMLS CUI [7,2]
C2348205
UMLS CUI [8]
C1563041
8. surgery within 30 days prior to screening
Beschreibung

Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0543467
9. serum creatinine >1.4 for women and >1.5 for men or egfr <60 [possible chronic kidney disease stage 3 or greater calculated using the modification of diet in renal disease (mdrd) equation.
Beschreibung

Creatinine measurement, serum | Gender | Estimated Glomerular Filtration Rate | Chronic Kidney Disease Stage MDRD

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
UMLS CUI [3]
C3811844
UMLS CUI [4,1]
C1561643
UMLS CUI [4,2]
C1306673
UMLS CUI [4,3]
C3839656
10. history of chronic liver disease including hepatitis b or c
Beschreibung

Chronic liver disease | Hepatitis B, Chronic | Hepatitis C, Chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0341439
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0524910
11. history of peptic ulcer or endoscopy demonstrated gastritis
Beschreibung

Peptic Ulcer | Gastritis Endoscopy

Datentyp

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2,1]
C0017152
UMLS CUI [2,2]
C0014245
12. history of acquired immune deficiency syndrome or human immunodeficiency virus (hiv)
Beschreibung

Acquired Immunodeficiency Syndrome | HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0001175
UMLS CUI [2]
C0019693
13. history of malignancy, except participants who have been disease-free for greater than 10 years, or whose only malignancy has been basal or squamous cell skin carcinoma
Beschreibung

Malignant Neoplasms | Disease Free of | Basal cell carcinoma | Squamous cell carcinoma of skin

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332296
UMLS CUI [3]
C0007117
UMLS CUI [4]
C0553723
14. new york heart association class iii or iv cardiac status or hospitalization for congestive heart failure
Beschreibung

Cardiac Status New York Heart Association Classification | Hospitalization Congestive heart failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1999091
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0018802
15. history of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack or any revascularization within 6 months
Beschreibung

Angina, Unstable | Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack | Revascularization

Datentyp

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0007787
UMLS CUI [5]
C0581603
16. uncontrolled hypertension (defined as systolic blood pressure >150 mmhg or diastolic blood pressure >95 mmhg on three or more assessments on more than one day)
Beschreibung

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
17. history of drug or alcohol abuse, or current weekly alcohol consumption >10 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed cocktail containing 1 ounce of alcohol)
Beschreibung

Substance Use Disorders | Alcohol consumption U/week | Beer U/week | Wine U/week | Cocktail Containing Alcohol U/week

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0560588
UMLS CUI [3,1]
C0004922
UMLS CUI [3,2]
C0560588
UMLS CUI [4,1]
C0043188
UMLS CUI [4,2]
C0560588
UMLS CUI [5,1]
C0678420
UMLS CUI [5,2]
C0332256
UMLS CUI [5,3]
C0001962
UMLS CUI [5,4]
C0560588
18. hemoglobin <12 g/dl (males), <10 g/dl (females) at screening
Beschreibung

Hemoglobin measurement | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
19. platelets <100,000 cu mm at screening.
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
20. ast (sgot) >2.50 x uln or alt (sgpt) >2.50 x uln at screening
Beschreibung

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
21. total bilirubin >1.50 x uln at screening
Beschreibung

Elevated total bilirubin

Datentyp

boolean

Alias
UMLS CUI [1]
C0741494
22. triglycerides (tg) >500 mg/dl at screening
Beschreibung

Triglycerides measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202236
23. poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study
Beschreibung

Mental function Poor | Reason for Protocol Compliance Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0563143
UMLS CUI [1,2]
C0542537
UMLS CUI [2,1]
C0392360
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0439801
24. previous allergy to aspirin
Beschreibung

Aspirin allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0004058
25. chronic or continuous use (daily for more than 7 days) of nonsteroidal anti-inflammatory drugs within the preceding 2 months
Beschreibung

Non-Steroidal Anti-Inflammatory Agents chronic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205191
26. use of warfarin (coumadin), clopidogrel (plavix) or other anticoagulants
Beschreibung

Warfarin | Coumadin | clopidogrel | Plavix | Anticoagulants

Datentyp

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0699129
UMLS CUI [3]
C0070166
UMLS CUI [4]
C0633084
UMLS CUI [5]
C0003280
27. use of probenecid (benemid, probalan), sulfinpyrazone (anturane) or other uricosuric agents
Beschreibung

Probenecid | Benemid | Sulfinpyrazone | Anturane | Uricosuric Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0033209
UMLS CUI [2]
C0591159
UMLS CUI [3]
C0038742
UMLS CUI [4]
C0591099
UMLS CUI [5]
C0041983
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Ähnliche Modelle

Eligibility Type 2 Diabetes NCT00392678

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise regime | Metformin | Insulin | alpha-Glucosidase Inhibitors
Item
1. type 2 diabetes on diet and exercise therapy or monotherapy with metformin, insulin secretagogue, or alpha-glucosidase inhibitors, or a low-dose combination of these at
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0454291 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
C0021641 (UMLS CUI [5])
C1299007 (UMLS CUI [6])
Combined Modality Therapy Low dose Stable
Item
≤ 50% maximal dose (see appendix). dosing is stable for 8 weeks prior to randomization.
boolean
C0009429 (UMLS CUI [1,1])
C0445550 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Plasma fasting glucose measurement | Glycosylated hemoglobin A
Item
2. fpg ≤ 225 mg/dl and hba1c>7% and ≤9.5% at screening
boolean
C0583513 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
Age
Item
3. age ≥18 and <75
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm
Item
4. women of childbearing potential agree to use an appropriate contraceptive method (hormonal, iud, or diaphragm)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C2985296 (UMLS CUI [2])
C0021900 (UMLS CUI [3])
C0042241 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Ketoacidosis
Item
1. type 1 diabetes and/or history of ketoacidosis determined by medical history
boolean
C0011854 (UMLS CUI [1])
C0220982 (UMLS CUI [2])
Diabetic Neuropathy Severe | Autonomic neuropathy | Gastroparesis | Leg Ulcer | Amputation of lower limb
Item
2. history of severe diabetic neuropathy including autonomic neuropathy, gastroparesis or lower limb ulceration or amputation
boolean
C0011882 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0259749 (UMLS CUI [2])
C0152020 (UMLS CUI [3])
C0023223 (UMLS CUI [4])
C0337308 (UMLS CUI [5])
Insulin Long-term
Item
3. history of long-term therapy with insulin (>30 days) within the last year
boolean
C0021641 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
rosiglitazone | Avandia | pioglitazone | Actos | exenatide | Byetta | Combined Modality Therapy
Item
4. therapy with rosiglitazone (avandia) or pioglitazone (actos), or extendin-4 (byetta), alone or in combination in the previous 6 months
boolean
C0289313 (UMLS CUI [1])
C0875967 (UMLS CUI [2])
C0071097 (UMLS CUI [3])
C0875954 (UMLS CUI [4])
C0167117 (UMLS CUI [5])
C1636686 (UMLS CUI [6])
C0009429 (UMLS CUI [7])
Pregnancy | Breast Feeding
Item
5. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Adrenal Cortex Hormones | Adrenal Cortex Hormones Oral Recurrent
Item
6. patients requiring corticosteroids within 3 months or recurrent continuous oral corticosteroid treatment (more than 2 weeks)
boolean
C0001617 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C2945760 (UMLS CUI [2,3])
Weight-Loss Agents | Xenical | orlistat | Meridia | sibutramine | Phenylpropanolamine | Non-Prescription Drugs Similar | Intentional weight loss
Item
7. use of weight loss drugs [e.g., xenical (orlistat), meridia (sibutramine), acutrim (phenylpropanol-amine), or similar over-the-counter medications] within 3 months of screening or intentional weight loss of ≥ 10 lbs in the previous 6 months
boolean
C0376606 (UMLS CUI [1])
C0732649 (UMLS CUI [2])
C0076275 (UMLS CUI [3])
C0635898 (UMLS CUI [4])
C0074493 (UMLS CUI [5])
C0031495 (UMLS CUI [6])
C0013231 (UMLS CUI [7,1])
C2348205 (UMLS CUI [7,2])
C1563041 (UMLS CUI [8])
Operative Surgical Procedures
Item
8. surgery within 30 days prior to screening
boolean
C0543467 (UMLS CUI [1])
Creatinine measurement, serum | Gender | Estimated Glomerular Filtration Rate | Chronic Kidney Disease Stage MDRD
Item
9. serum creatinine >1.4 for women and >1.5 for men or egfr <60 [possible chronic kidney disease stage 3 or greater calculated using the modification of diet in renal disease (mdrd) equation.
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C3811844 (UMLS CUI [3])
C1561643 (UMLS CUI [4,1])
C1306673 (UMLS CUI [4,2])
C3839656 (UMLS CUI [4,3])
Chronic liver disease | Hepatitis B, Chronic | Hepatitis C, Chronic
Item
10. history of chronic liver disease including hepatitis b or c
boolean
C0341439 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
Peptic Ulcer | Gastritis Endoscopy
Item
11. history of peptic ulcer or endoscopy demonstrated gastritis
boolean
C0030920 (UMLS CUI [1])
C0017152 (UMLS CUI [2,1])
C0014245 (UMLS CUI [2,2])
Acquired Immunodeficiency Syndrome | HIV Infection
Item
12. history of acquired immune deficiency syndrome or human immunodeficiency virus (hiv)
boolean
C0001175 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
Malignant Neoplasms | Disease Free of | Basal cell carcinoma | Squamous cell carcinoma of skin
Item
13. history of malignancy, except participants who have been disease-free for greater than 10 years, or whose only malignancy has been basal or squamous cell skin carcinoma
boolean
C0006826 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3])
C0553723 (UMLS CUI [4])
Cardiac Status New York Heart Association Classification | Hospitalization Congestive heart failure
Item
14. new york heart association class iii or iv cardiac status or hospitalization for congestive heart failure
boolean
C1999091 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0018802 (UMLS CUI [2,2])
Angina, Unstable | Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack | Revascularization
Item
15. history of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack or any revascularization within 6 months
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
C0581603 (UMLS CUI [5])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
16. uncontrolled hypertension (defined as systolic blood pressure >150 mmhg or diastolic blood pressure >95 mmhg on three or more assessments on more than one day)
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Substance Use Disorders | Alcohol consumption U/week | Beer U/week | Wine U/week | Cocktail Containing Alcohol U/week
Item
17. history of drug or alcohol abuse, or current weekly alcohol consumption >10 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed cocktail containing 1 ounce of alcohol)
boolean
C0038586 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0560588 (UMLS CUI [2,2])
C0004922 (UMLS CUI [3,1])
C0560588 (UMLS CUI [3,2])
C0043188 (UMLS CUI [4,1])
C0560588 (UMLS CUI [4,2])
C0678420 (UMLS CUI [5,1])
C0332256 (UMLS CUI [5,2])
C0001962 (UMLS CUI [5,3])
C0560588 (UMLS CUI [5,4])
Hemoglobin measurement | Gender
Item
18. hemoglobin <12 g/dl (males), <10 g/dl (females) at screening
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Platelet Count measurement
Item
19. platelets <100,000 cu mm at screening.
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
20. ast (sgot) >2.50 x uln or alt (sgpt) >2.50 x uln at screening
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Elevated total bilirubin
Item
21. total bilirubin >1.50 x uln at screening
boolean
C0741494 (UMLS CUI [1])
Triglycerides measurement
Item
22. triglycerides (tg) >500 mg/dl at screening
boolean
C0202236 (UMLS CUI [1])
Mental function Poor | Reason for Protocol Compliance Limited
Item
23. poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study
boolean
C0563143 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Aspirin allergy
Item
24. previous allergy to aspirin
boolean
C0004058 (UMLS CUI [1])
Non-Steroidal Anti-Inflammatory Agents chronic
Item
25. chronic or continuous use (daily for more than 7 days) of nonsteroidal anti-inflammatory drugs within the preceding 2 months
boolean
C0003211 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Warfarin | Coumadin | clopidogrel | Plavix | Anticoagulants
Item
26. use of warfarin (coumadin), clopidogrel (plavix) or other anticoagulants
boolean
C0043031 (UMLS CUI [1])
C0699129 (UMLS CUI [2])
C0070166 (UMLS CUI [3])
C0633084 (UMLS CUI [4])
C0003280 (UMLS CUI [5])
Probenecid | Benemid | Sulfinpyrazone | Anturane | Uricosuric Agents
Item
27. use of probenecid (benemid, probalan), sulfinpyrazone (anturane) or other uricosuric agents
boolean
C0033209 (UMLS CUI [1])
C0591159 (UMLS CUI [2])
C0038742 (UMLS CUI [3])
C0591099 (UMLS CUI [4])
C0041983 (UMLS CUI [5])
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