ID

24029

Description

Predictive Markers of Glitazone Efficacy in Diabetic Patients - Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT00481429

Link

https://clinicaltrials.gov/show/NCT00481429

Keywords

Versions (1)
  1. 7/23/17 7/23/17 -
Uploaded on

July 23, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00481429

English

Eligibility Diabetes Mellitus, Type 2 NCT00481429

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male subjects aged 18 to 65 years.
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. eligible subjects must be free from clinically significant illness or disease (other than type 2 diabetes)with the exception of chronic stable-treated hypertension (bp<160/90, and >90/50), thyroid disease (tsh in the normal reference range) and/or dyslipidaemia.
Description

Illness Clinical Significance Free of | Non-Insulin-Dependent Diabetes Mellitus Excluded | Chronic hypertension Treated Stable | Blood pressure | Thyroid Diseases | Serum TSH level normal | Dyslipidemias

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0332296
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C2828389
UMLS CUI [3,1]
C0745114
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C0205360
UMLS CUI [4]
C1271104
UMLS CUI [5]
C0040128
UMLS CUI [6]
C0580433
UMLS CUI [7]
C0242339
3. bmi must be > or = 25kg/m2 to < or = 40kg/m2,
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
4. hba1c between 7and 10%, fasting blood glucose above 7mmol/l (fasting means greater or = 8 hours prior to screening).
Description

Glycosylated hemoglobin A | Fasting blood glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0019018
UMLS CUI [2]
C0428568
5. on diet alone or diet plus metformin (gsk data indicate that the latter group more faithfully reflect the behaviour of 'naive' patients than those who have been washed off prior medications)for at least 1 month.
Description

Diet therapy | Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0025598
6. on stable doses of anti-hypertensive medication, thyroid hormone replacement and statin therapy as required.
Description

Antihypertensive Agents Dose Stable | Thyroid hormone replacement therapy | Statin therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C2242640
UMLS CUI [3]
C1278454
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior treatment with thiazolidinedione, insulin or glp-1 analogue (byetta)
Description

Thiazolidinediones | Insulin regime | GLP-1 Analogue | Byetta

Data type

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C0557978
UMLS CUI [3,1]
C0061355
UMLS CUI [3,2]
C0243071
UMLS CUI [4]
C1636686
2. history of hepatic disease, impairment or abnormal liver function test i.e. ast, alt>2 times upper limit of normal range (uln), bilirubin>1.5 time uln.
Description

Liver disease | Hepatic impairment | Liver function tests abnormal | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0948807
UMLS CUI [3]
C0151766
UMLS CUI [4]
C0151904
UMLS CUI [5]
C0151905
UMLS CUI [6]
C0741494
history of renal disease or serum creatinine greater than 1.5 x uln.
Description

Kidney Diseases | Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0700225
3. contraindications to rosiglitazone treatment.
Description

Medical contraindication rosiglitazone

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0289313
4. serum creatinine greater than 1.5 x upper limit of normal range.
Description

Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0700225
5. any other clinically significant laboratory abnormality.
Description

Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
6. claustrophobic or other contraindication to mri scan
Description

Claustrophobia | Medical contraindication Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1]
C0008909
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0024485
7. females of child-bearing age who are unwilling to use appropriate methods of contraception.
Description

Childbearing Potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
8. unable to give informed consent.
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
9. unable to comply with study protocol.
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
10. clinically significant co-morbidity. -
Description

Comorbidity Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2826293
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00481429

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. male subjects aged 18 to 65 years.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Illness Clinical Significance Free of | Non-Insulin-Dependent Diabetes Mellitus Excluded | Chronic hypertension Treated Stable | Blood pressure | Thyroid Diseases | Serum TSH level normal | Dyslipidemias
Item
2. eligible subjects must be free from clinically significant illness or disease (other than type 2 diabetes)with the exception of chronic stable-treated hypertension (bp<160/90, and >90/50), thyroid disease (tsh in the normal reference range) and/or dyslipidaemia.
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
C0011860 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0745114 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1271104 (UMLS CUI [4])
C0040128 (UMLS CUI [5])
C0580433 (UMLS CUI [6])
C0242339 (UMLS CUI [7])
Body mass index
Item
3. bmi must be > or = 25kg/m2 to < or = 40kg/m2,
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A | Fasting blood glucose measurement
Item
4. hba1c between 7and 10%, fasting blood glucose above 7mmol/l (fasting means greater or = 8 hours prior to screening).
boolean
C0019018 (UMLS CUI [1])
C0428568 (UMLS CUI [2])
Diet therapy | Metformin
Item
5. on diet alone or diet plus metformin (gsk data indicate that the latter group more faithfully reflect the behaviour of 'naive' patients than those who have been washed off prior medications)for at least 1 month.
boolean
C0012159 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
Antihypertensive Agents Dose Stable | Thyroid hormone replacement therapy | Statin therapy
Item
6. on stable doses of anti-hypertensive medication, thyroid hormone replacement and statin therapy as required.
boolean
C0003364 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C2242640 (UMLS CUI [2])
C1278454 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Thiazolidinediones | Insulin regime | GLP-1 Analogue | Byetta
Item
1. prior treatment with thiazolidinedione, insulin or glp-1 analogue (byetta)
boolean
C1257987 (UMLS CUI [1])
C0557978 (UMLS CUI [2])
C0061355 (UMLS CUI [3,1])
C0243071 (UMLS CUI [3,2])
C1636686 (UMLS CUI [4])
Liver disease | Hepatic impairment | Liver function tests abnormal | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin
Item
2. history of hepatic disease, impairment or abnormal liver function test i.e. ast, alt>2 times upper limit of normal range (uln), bilirubin>1.5 time uln.
boolean
C0023895 (UMLS CUI [1])
C0948807 (UMLS CUI [2])
C0151766 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0151905 (UMLS CUI [5])
C0741494 (UMLS CUI [6])
Kidney Diseases | Serum creatinine raised
Item
history of renal disease or serum creatinine greater than 1.5 x uln.
boolean
C0022658 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Medical contraindication rosiglitazone
Item
3. contraindications to rosiglitazone treatment.
boolean
C1301624 (UMLS CUI [1,1])
C0289313 (UMLS CUI [1,2])
Serum creatinine raised
Item
4. serum creatinine greater than 1.5 x upper limit of normal range.
boolean
C0700225 (UMLS CUI [1])
Laboratory test result abnormal
Item
5. any other clinically significant laboratory abnormality.
boolean
C0438215 (UMLS CUI [1])
Claustrophobia | Medical contraindication Magnetic Resonance Imaging
Item
6. claustrophobic or other contraindication to mri scan
boolean
C0008909 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods Unwilling
Item
7. females of child-bearing age who are unwilling to use appropriate methods of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Informed Consent Unable
Item
8. unable to give informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Protocol Compliance Unable
Item
9. unable to comply with study protocol.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Comorbidity Clinical Significance
Item
10. clinically significant co-morbidity. -
boolean
C0009488 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
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