Age
Item
1. male and female patients age 18 to 70 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
2. ability to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Mental state Stable | Protocol Compliance
Item
3. mentally stable and able to comply with the procedures of the study protocol
boolean
C0278060 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
History of clinical finding Consistent with Impaired fasting glycaemia | History of clinical finding Consistent with Non-Insulin-Dependent Diabetes Mellitus Early | Plasma Glucose Measurement | Status post Overnight Fasting | Antidiabetics Absent | Thiazolidinediones Absent
Item
4. clinical history compatible with impaired fasting glucose or early t2d as defined by a plasma glucose concentration between 110-159 mg/dl following a 12 hour overnight fast performed off any anti-diabetogenic agent for at least 2 weeks (6 weeks for thiazolidinediones)
boolean
C2317559 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C1272092 (UMLS CUI [1,3])
C2317559 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0011860 (UMLS CUI [2,3])
C1279919 (UMLS CUI [2,4])
C0202042 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0439583 (UMLS CUI [4,2])
C0015663 (UMLS CUI [4,3])
C0935929 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C1257987 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Stable body weight Duration
Item
5. stable body weight (+ 5%) for at least 2 weeks
boolean
C0517386 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Hormonal contraception | Contraception, Barrier | Female Sterilization
Item
6. female patients: agree to use adequate contraception if reproductively capable. adequate contraception includes either a hormonal or barrier method, or surgical sterilization.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C2985296 (UMLS CUI [2])
C0004764 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
Diabetes Mellitus, Insulin-Dependent
Item
1. diagnosis of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Insulin | exenatide | Byetta | sitagliptin | Januvia | Antidiabetics Oral Quantity Diabetes Therapy
Item
2. receiving insulin, exenatide (byetta®), or sitagliptin (januvia®) treatment or taking > 2 oral anti-diabetogenic agents for the treatment of diabetes
boolean
C0021641 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1636686 (UMLS CUI [3])
C1565750 (UMLS CUI [4])
C1702177 (UMLS CUI [5])
C0935929 (UMLS CUI [6,1])
C1527415 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
C3274787 (UMLS CUI [6,4])
Body mass index
Item
3. bmi > 44 kg/m2
boolean
C1305855 (UMLS CUI [1])
Allergy to sulfonamides
Item
4. allergy to any sulfa-containing compounds
boolean
C0038757 (UMLS CUI [1])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
5. uncontrolled hypertension (sbp >160 or dbp > 100 mmhg)
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Hyperlipidemia Uncontrolled | Triglycerides measurement | LDL cholesterol measurement
Item
6. uncontrolled hyperlipidemia (triglycerides > 500 or ldl > 160 mg/dl)
boolean
C0020473 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0202236 (UMLS CUI [2])
C0202117 (UMLS CUI [3])
Increased liver function tests
Item
7. elevation of liver function tests > 2 times the upper limit of normal
boolean
C0877359 (UMLS CUI [1])
Estimated Glomerular Filtration Rate
Item
8. estimated gfr < 55 ml/min/1.73m2 (46)
boolean
C3811844 (UMLS CUI [1])
Hyperkalemia | Serum potassium measurement
Item
9. hyperkalemia (serum potassium > 5.5 mmol/l)
boolean
C0020461 (UMLS CUI [1])
C0302353 (UMLS CUI [2])
Anemia Moderate | Hemoglobin measurement | Gender
Item
10. moderate anemia (hemoglobin concentration < 12 g/dl in men and < 11 g/dl in women)
boolean
C0002871 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
11. female patients: pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Liver Cirrhosis
Item
12. hepatic cirrhosis
boolean
C0023890 (UMLS CUI [1])
Substance Use Disorders
Item
13. known active alcohol or substance abuse
boolean
C0038586 (UMLS CUI [1])
Cardiovascular Disease
Item
14. active cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Investigational New Drugs
Item
15. use of any investigational agent within 6 weeks of the baseline visit
boolean
C0013230 (UMLS CUI [1])
Medical condition Interferes with Completion of clinical trial
Item
16. any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])