Body mass index
Item
1. body mass index (bmi) ≥ 28 and ≤ 45 (kg/m2)
boolean
C1305855 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
2. type 2 diabetes >6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral
Item
3. type 2 diabetic subjects treated with oral anti-diabetic
boolean
C0011860 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
Antidiabetics Stable | Thiazolidinediones
Item
4. stable anti-diabetic medications ≥3 months prior to enrollment, six months for tzd
boolean
C0935929 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1257987 (UMLS CUI [2])
Hemoglobin A1c measurement | Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
5. hba1c ≥7.5% and ≤ 9.5 % at visit 1, subjects with t2dm duration > 10 yrs should have hba1c ≥7.5% and ≤ 9.0
boolean
C0474680 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
Glycosylated hemoglobin A Stable | Stable body weight | Antihypertensive Agents Stable | Hypolipidemic Agents Stable
Item
6. stable hba1c, stable weight, and stable treatment with anti-hypertensive and/or lipids lowering medications
boolean
C0019018 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0517386 (UMLS CUI [2])
C0003364 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0086440 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
Fasting blood glucose measurement | Diabetes Mellitus, Non-Insulin-Dependent
Item
7. fasting blood glucose >120 and < 240 mg/dl at visit 1, subjects with t2dm duration > 10 yrs should be >120 and ≤180.
boolean
C0428568 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Childbearing Potential Contraceptive methods
Item
8. women with childbearing potential must agree to use adequate birth control methods
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Stable body weight | Body Weight Variation Percentage
Item
9. stable weight - no significant change (variation < 5%) in the last 6 months
boolean
C0517386 (UMLS CUI [1])
C0005910 (UMLS CUI [2,1])
C0205419 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Blood glucose test capillary times/day times/week
Item
10. willingness to perform at least 4 capillary blood glucose tests per day twice a week for the duration of the study
boolean
C0392201 (UMLS CUI [1,1])
C0006901 (UMLS CUI [1,2])
C0439511 (UMLS CUI [1,3])
C0456698 (UMLS CUI [1,4])
Avoidance Weight-Loss Agents | Avoidance Weight-Loss Agents over-the-counter | Avoidance HERBAL WEIGHT LOSS AID
Item
11. willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of the trial
boolean
C0870186 (UMLS CUI [1,1])
C0376606 (UMLS CUI [1,2])
C0870186 (UMLS CUI [2,1])
C0376606 (UMLS CUI [2,2])
C0013231 (UMLS CUI [2,3])
C0870186 (UMLS CUI [3,1])
C1572271 (UMLS CUI [3,2])
Protocol Compliance
Item
12. ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the tantalus ii system
boolean
C0525058 (UMLS CUI [1])
Mentally alert | Competence
Item
13. alert, mentally competent,
boolean
C0424536 (UMLS CUI [1])
C0086035 (UMLS CUI [2])
Informed Consent
Item
14. able to provide voluntary informed consent and hipaa authorization
boolean
C0021430 (UMLS CUI [1])
Insulin regime
Item
1. receiving insulin therapy
boolean
C0557978 (UMLS CUI [1])
GLP-1 | Amylin | Byetta | Symlin
Item
2. taking glp-1, amylin treatment (byetta, symlin)
boolean
C0061355 (UMLS CUI [1])
C0063684 (UMLS CUI [2])
C1636686 (UMLS CUI [3])
C1174780 (UMLS CUI [4])
Blood pressure determination
Item
3. blood pressure levels of >180/100
boolean
C0005824 (UMLS CUI [1])
Cardiac ejection fraction | Indication ICD | Echocardiography Required
Item
4. patients with an ef less than 35% (obtained within last 6 months) or indicated for an icd; if echocardiogram outdated or unavailable, procedure to be done
boolean
C0232174 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0162589 (UMLS CUI [2,2])
C0013516 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Pharmaceutical Preparations Affecting Gastric motility | Narcotics chronic | Anticholinergic Agents | Antispasmodics
Item
5. taking medications known to affect gastric motility such as narcotics (chronic use) and anticholinergics/antispasmodics
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0232572 (UMLS CUI [1,3])
C0027415 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0242896 (UMLS CUI [3])
C0037766 (UMLS CUI [4])
Weight-Loss Agents | Weight-Loss Agents over-the-counter | HERBAL WEIGHT LOSS AID | Anti-Obesity Agents
Item
6. use of prescription, over the counter or herbal weight loss products or obesity drugs during the two months prior to enrollment
boolean
C0376606 (UMLS CUI [1])
C0376606 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C1572271 (UMLS CUI [3])
C0376607 (UMLS CUI [4])
Complications of Diabetes Mellitus Severe Progressing | Diabetic Retinopathy Unstable | Kidney Disease With Macroalbuminuria
Item
7. experiencing severe and progressing diabetic complications (i.e. retinopathy not stabilized, nephropathy with macroalbuminuria)
boolean
C0342257 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205329 (UMLS CUI [1,3])
C0011884 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C1654921 (UMLS CUI [3,3])
Wound Healing Problem Due to Staphylococcus | Wound Healing Problem Due to Candida
Item
8. prior wound healing problems due to staphylococcus and candida
boolean
C0043240 (UMLS CUI [1,1])
C0033213 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0038170 (UMLS CUI [1,4])
C0043240 (UMLS CUI [2,1])
C0033213 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0006836 (UMLS CUI [2,4])
Bariatric Surgery
Item
9. prior bariatric surgery
boolean
C1456587 (UMLS CUI [1])
Pancreatitis
Item
10. history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
Peptic Ulcer
Item
11. history of peptic ulcer disease within 5 years of enrollment
boolean
C0030920 (UMLS CUI [1])
Gastroparesis
Item
12. diagnosed with gastroparesis
boolean
C0152020 (UMLS CUI [1])
Implants | Medical Devices External | ICD | Artificial cardiac pacemaker | Implantable Neurostimulators | Neurostimulator
Item
13. use of active medical devices (either implantable or external) such as icd, pacemaker, neurostimulator (either implanted or worn). subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.
boolean
C0021102 (UMLS CUI [1])
C0025080 (UMLS CUI [2,1])
C0205101 (UMLS CUI [2,2])
C0162589 (UMLS CUI [3])
C0030163 (UMLS CUI [4])
C2048402 (UMLS CUI [5])
C0582124 (UMLS CUI [6])
Heart Disease
Item
14. cardiac history that physician feels should exclude the patient
boolean
C0018799 (UMLS CUI [1])
Investigational Medical Device | Investigational New Drugs
Item
15. use of another investigational device or agent in the 30 days prior to enrollment
boolean
C2346570 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Disease Life Threatening
Item
16. a history of life-threatening disease within 5 years of enrollment
boolean
C0012634 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Condition Study Subject Participation Status Exclusion | Patient condition Preventing Completion of clinical trial
Item
17. any additional condition(s) that in the investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0683521 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])