Study Subject Participation Status
Item
to participate patients must:
boolean
C2348568 (UMLS CUI [1])
Able to communicate Investigator | Informed Consent
Item
1. be able to communicate meaningfully with the investigator and be legally competent to provide written informed consent.
boolean
C2364293 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Gender Breast Feeding Absent | Postmenopausal state | Gender Contraceptive methods | Contraceptives, Oral | Hormone implant | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Female Sterilization | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy | Gender Pregnancy test negative
Item
2. female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). female patients who have undergone a hysterectomy are eligible for participation in the study. female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period.
boolean
C0079399 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0232970 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0009905 (UMLS CUI [4])
C0848131 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0042241 (UMLS CUI [7])
C0087145 (UMLS CUI [8])
C0221829 (UMLS CUI [9])
C0015787 (UMLS CUI [10])
C0589114 (UMLS CUI [11])
C0278321 (UMLS CUI [12])
C0020699 (UMLS CUI [13])
C0079399 (UMLS CUI [14,1])
C0427780 (UMLS CUI [14,2])
Age
Item
3. age range of 18 to 70 years (inclusive).
boolean
C0001779 (UMLS CUI [1])
Pharmaceutical Preparations chronic Dose Stable | Therapeutic procedure Double-Blind Method
Item
4. patients must have been on a stable dose of allowed chronic medications for two months prior to entering the double-blind treatment period.
boolean
C0013227 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0087111 (UMLS CUI [2,1])
C0013072 (UMLS CUI [2,2])
Laboratory Results Required
Item
5. all participants must have the following laboratory values:
boolean
C1254595 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Hemoglobin measurement | Gender
Item
hemoglobin ≥ 12 g/dl in males or ≥ 11 g/dl in females
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Creatinine measurement, serum
Item
serum creatinine ≤ 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
ast (sgot) ≤ 2.5 times upper limit of normal
boolean
C0201899 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
alt (sgpt) ≤ 2.5 times upper limit of normal
boolean
C0201836 (UMLS CUI [1])
Alkaline phosphatase measurement
Item
alkaline phosphatase ≤ 2.5 times upper limit of normal
boolean
C0201850 (UMLS CUI [1])
Criteria Present
Item
patients will be excluded if any of the following criteria are present:
boolean
C0243161 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Associated with Plasma fasting glucose measurement
Item
1. individuals with type 1 diabetes or type 2 diabetes and a fpg ≥ 300 mg/dl.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0583513 (UMLS CUI [2,3])
Sulfonylureas | Metformin | Thiazolidinediones | Exception Dose Stable
Item
2. subjects on sulfonylureas, metformin and/or tzds unless the dose has been stable for at least 2 months prior to study entry.
boolean
C0038766 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Thiazide Diuretics | Furosemide | Adrenergic beta-Antagonists | Adverse effects of medical drugs Glucose tolerance Level | Exception Pharmaceutical Preparations Dose Stable | Estrogens Dose Stable allowed | Hormone replacement therapy Stable allowed | Glucocorticoids, Systemic
Item
3. patients on any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on stable doses of such agents for the past two months before entry into the study. patients may be taking stable doses of estrogens or other hormonal replacement therapy if the patient has been on these agents for the prior two months. patients taking systemic glucocorticoids will be excluded.
boolean
C0012802 (UMLS CUI [1])
C0016860 (UMLS CUI [2])
C0001645 (UMLS CUI [3])
C0810090 (UMLS CUI [4,1])
C0178665 (UMLS CUI [4,2])
C0441889 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C0178602 (UMLS CUI [5,3])
C0205360 (UMLS CUI [5,4])
C0014939 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0683607 (UMLS CUI [6,4])
C0282402 (UMLS CUI [7,1])
C0205360 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])
C3540777 (UMLS CUI [8])
Alcohol abuse
Item
4. past (within 1 year) or current history of alcohol abuse.
boolean
C0085762 (UMLS CUI [1])
Heart Disease New York Heart Association Classification | Peripheral Vascular Disease | Claudication | Lung disease | Dyspnea on exertion | Abnormal breath sounds Auscultation | Kidney Failure, Chronic | Creatinine measurement, serum
Item
5. patients will be excluded if there is a history of clinically significant heart disease (new york heart classification greater than grade ii), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) or chronic renal failure (serum creatinine greater than 1.5 mg/dl).
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0085096 (UMLS CUI [2])
C1456822 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0231807 (UMLS CUI [5])
C0231856 (UMLS CUI [6,1])
C0004339 (UMLS CUI [6,2])
C0022661 (UMLS CUI [7])
C0201976 (UMLS CUI [8])