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])
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])