age 18 Years to 70 Years
Item
age 18 Years to 70 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Body mass index >=28 and <=45 (kg/m2)
Item
Body mass index
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
Type 2 diabetes duration more than 6 month
Item
Type 2 diabetes duration more than 6 month
boolean
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0449238 (UMLS CUI 2011AA)
103335007 (SNOMED CT 2011_0131)
MTHU001938 (LOINC Version 232)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Type 2 diabetic sublecys treated with oral anti-diabetic agents
Item
Type 2 diabetic sublecys treated with oral anti-diabetic agents
boolean
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
CL415147 (UMLS CUI 2011AA)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
Stable anti-diabetic medication for at least 3 month prior to enrollment
Item
Stable anti-diabetic medication for at least 3 month prior to enrollment
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
HbA1c >=7.5% and <=9.5% on visit 1. Subjects with T2DM duration .10 years should have <=9.0% at visit 1
Item
HbA1c >=7.5% and <=9.5% on visit 1. Subjects with T2DM duration .10 years should have <=9.0% at visit 1
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
Stable HbA1c, defined as no significant change (variation <=0.5%)between a historical value recorded in the subject's medical record with in 3 month prior to enrollment and the HbA1c gathered at visit 1
Item
Stable HbA1c, defined as no significant change (variation <=0.5%)between a historical value recorded in the subject's medical record with in 3 month prior to enrollment and the HbA1c gathered at visit 1
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0392747 (UMLS CUI 2011AA)
243326001 (SNOMED CT 2011_0131)
Fasting blood glucose >120 and < 240 mg/dl on visit 1. Subjects with T2DM duration > 10 yaers should have .120 ans<=180 mg/dl at visit 1
Item
Fasting blood glucose >120 and < 240 mg/dl on visit 1. Subjects with T2DM duration > 10 yaers should have .120 ans<=180 mg/dl at visit 1
boolean
C0428568 (UMLS CUI 2011AA)
271062006 (SNOMED CT 2011_0131)
10051566 (MedDRA 14.1)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
Women with child bearing potential (i.e, not post menopausal or surgically sterilized) must agree to use adequate birth control methods
Item
Women with child bearing potential (i.e, not post menopausal or surgically sterilized) must agree to use adequate birth control methods
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C1518422 (UMLS CUI 2011AA)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0015787 (UMLS CUI 2011AA)
169549004 (SNOMED CT 2011_0131)
10056199 (MedDRA 14.1)
Stable weight, defined as no significant weight change (variation <5%)within three months prior to enrollment
Item
Stable weight, defined as no significant weight change (variation <5%)within three months prior to enrollment
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C1305866 (UMLS CUI 2011AA)
107647005 (SNOMED CT 2011_0131)
10047890 (MedDRA 14.1)
LP18015-5 (LOINC Version 232)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0005911 (UMLS CUI 2011AA)
248346009 (SNOMED CT 2011_0131)
MTHU021183 (LOINC Version 232)
If taking these medication, stable anti-hepertensive and lipid-lowering medication for at least one month prior to enrollment
Item
If taking these medication, stable anti-hepertensive and lipid-lowering medication for at least one month prior to enrollment
boolean
C0750557 (UMLS CUI 2011AA)
C1512806 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0003364 (UMLS CUI 2011AA)
372586001 (SNOMED CT 2011_0131)
C0086440 (UMLS CUI 2011AA)
57952007 (SNOMED CT 2011_0131)
If subject is under anti-depressant medication the treatment needs to be stable for at least six month prior to enrollment
Item
If subject is under anti-depressant medication the treatment needs to be stable for at least six month prior to enrollment
boolean
C0750557 (UMLS CUI 2011AA)
C1514756 (UMLS CUI 2011AA)
C0003289 (UMLS CUI 2011AA)
372720008 (SNOMED CT 2011_0131)
MTHU006782 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
Willingness to refrain from using prescription, over the counter or herbal weight loss product for the duration of the trial
Item
Willingness to refrain from using prescription, over the counter or herbal weight loss product for the duration of the trial
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0870186 (UMLS CUI 2011AA)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
C0013231 (UMLS CUI 2011AA)
329505003, 80288002 (SNOMED CT 2011_0131)
C0376606 (UMLS CUI 2011AA)
C1572271 (UMLS CUI 2011AA)
Ability and willingliness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS II System
Item
Ability and willingliness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS II System
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0010995 (UMLS CUI 2011AA)
C2700391 (UMLS CUI 2011AA)
C0525058 (UMLS CUI 2011AA)
Alert, mentally competant, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial
Item
Alert, mentally competant, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial
boolean
C0086035 (UMLS CUI 2011AA)
32082000 (SNOMED CT 2011_0131)
C1273101 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Able to provide voluntary informed consent
Item
Able to provide voluntary informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Insulin therapy
Item
Insulin therapy
boolean
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
Taking GLP-1 analogue, such as exenatide (Byette) in the last 3 month before enrollment Taking medication known to affect gastric mobility such as narcotics (chronic use) and anticholinergics/antispasmodics
Item
Taking GLP-1 analogue, such as exenatide (Byette) in the last 3 month before enrollment Taking medication known to affect gastric mobility such as narcotics (chronic use) and anticholinergics/antispasmodics
boolean
C1512806 (UMLS CUI 2011AA)
CL430618 (UMLS CUI 2011AA)
C0167117 (UMLS CUI 2011AA)
416859008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0232572 (UMLS CUI 2011AA)
36735000 (SNOMED CT 2011_0131)
C0027415 (UMLS CUI 2011AA)
MTHU003470 (LOINC Version 232)
C0242896 (UMLS CUI 2011AA)
14601000 (SNOMED CT 2011_0131)
C0037766 (UMLS CUI 2011AA)
8696009 (SNOMED CT 2011_0131)
Use of prescription, over the counter or herbal weight loss product or obesity drugs during the past two month
Item
Use of prescription, over the counter or herbal weight loss product or obesity drugs during the past two month
boolean
C0376606 (UMLS CUI 2011AA)
Experiencing severe and progressing diabetic complications (i.e retinopathy not stabilized, nephropathy with macroalbuminuria)
Item
Experiencing severe and progressing diabetic complications (i.e retinopathy not stabilized, nephropathy with macroalbuminuria)
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0342257 (UMLS CUI 2011AA)
74627003 (SNOMED CT 2011_0131)
10061104 (MedDRA 14.1)
250.9 (ICD-9-CM Version 2011)
C1518422 (UMLS CUI 2011AA)
C0184512 (UMLS CUI 2011AA)
409051000 (SNOMED CT 2011_0131)
C0011884 (UMLS CUI 2011AA)
4855003 (SNOMED CT 2011_0131)
10012689 (MedDRA 14.1)
MTHU020818 (LOINC Version 232)
362.0 (ICD-9-CM Version 2011)
C0011881 (UMLS CUI 2011AA)
127013003 (SNOMED CT 2011_0131)
10061835 (MedDRA 14.1)
250.4 (ICD-9-CM Version 2011)
C2984010 (UMLS CUI 2011AA)
C0001925 (UMLS CUI 2011AA)
274769005 (SNOMED CT 2011_0131)
10001580 (MedDRA 14.1)
R80.9 (ICD-10-CM Version 2010)
Prior wound healing problems
Item
Prior wound healing problems
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1096106 (UMLS CUI 2011AA)
10053692 (MedDRA 14.1)
E12057 (CTCAE 1105E)
Diagnosed with past or present psychiatric condition that may impair his or her ability to comply with the study procedure
Item
Diagnosed with past or present psychiatric condition that may impair his or her ability to comply with the study procedure
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0278060 (UMLS CUI 2011AA)
36456004 (SNOMED CT 2011_0131)
MTHU001424 (LOINC Version 232)
MTHU117157 (CTCAE 1105E)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
Use of anti-psychotic medication
Item
Use of anti-psychotic medication
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0040615 (UMLS CUI 2011AA)
10784006, 372482001 (SNOMED CT 2011_0131)
MTHU003337 (LOINC Version 232)
Diagnosed with an eating disorder such as bulimia or binge eating
Item
Diagnosed with an eating disorder such as bulimia or binge eating
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0013473 (UMLS CUI 2011AA)
72366004 (SNOMED CT 2011_0131)
10014062 (MedDRA 14.1)
F50.9 (ICD-10-CM Version 2010)
307.50 (ICD-9-CM Version 2011)
C0006370 (UMLS CUI 2011AA)
78004001 (SNOMED CT 2011_0131)
10006549 (MedDRA 14.1)
F50.2 (ICD-10-CM Version 2010)
C0596170 (UMLS CUI 2011AA)
439960005 (SNOMED CT 2011_0131)
F50.2 (ICD-10-CM Version 2010)
Obesity due to endocrinopathy (e.g.Cushing disease, Hypothyroidism)
Item
Obesity due to endocrinopathy (e.g.Cushing disease, Hypothyroidism)
boolean
C0028754 (UMLS CUI 2011AA)
414916001 (SNOMED CT 2011_0131)
10029883 (MedDRA 14.1)
E66.0 (ICD-10-CM Version 2010)
278.00 (ICD-9-CM Version 2011)
E12361 (CTCAE 1105E)
CL420107 (UMLS CUI 2011AA)
C0014130 (UMLS CUI 2011AA)
362969004 (SNOMED CT 2011_0131)
10014695 (MedDRA 14.1)
MTHU021570 (LOINC Version 232)
E34.9 (ICD-10-CM Version 2010)
259.9 (ICD-9-CM Version 2011)
C0010481 (UMLS CUI 2011AA)
47270006 (SNOMED CT 2011_0131)
10011652 (MedDRA 14.1)
E24.9 (ICD-10-CM Version 2010)
255.0 (ICD-9-CM Version 2011)
C0020676 (UMLS CUI 2011AA)
40930008 (SNOMED CT 2011_0131)
10021114 (MedDRA 14.1)
MTHU020783 (LOINC Version 232)
E03.9 (ICD-10-CM Version 2010)
244.9 (ICD-9-CM Version 2011)
E10334 (CTCAE 1105E)
Hiatal hernia requiring surgical repair or paraesophageal hernia
Item
Hiatal hernia requiring surgical repair or paraesophageal hernia
boolean
CL432890 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0374711 (UMLS CUI 2011AA)
4365001 (SNOMED CT 2011_0131)
C0267725 (UMLS CUI 2011AA)
3662000 (SNOMED CT 2011_0131)
10059188 (MedDRA 14.1)
K44 (ICD-10-CM Version 2010)
Pregnant or lactating
Item
Pregnant or lactating
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
Diagnosed with impaired liver function (liver enzymes 3 times graeted than normal)
Item
Diagnosed with impaired liver function (liver enzymes 3 times graeted than normal)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
Any prior bariatric surgery
Item
Any prior bariatric surgery
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1456587 (UMLS CUI 2011AA)
10068900 (MedDRA 14.1)
Any history of pancreatitis
Item
Any history of pancreatitis
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0030305 (UMLS CUI 2011AA)
75694006 (SNOMED CT 2011_0131)
10033645 (MedDRA 14.1)
K85.9 (ICD-10-CM Version 2010)
577.0 (ICD-9-CM Version 2011)
E10930 (CTCAE 1105E)
Any history of peptic ulcer disease within 5 years of enrollment
Item
Personal history of peptic ulcer disease
boolean
C0375803 (UMLS CUI 2011AA)
Z87.11 (ICD-10-CM Version 2010)
V12.71 (ICD-9-CM Version 2011)
Diagnosed with gastroparesis or GI motility disorder
Item
Diagnosed with gastroparesis or GI motility disorder
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0152020 (UMLS CUI 2011AA)
235675006 (SNOMED CT 2011_0131)
10018043 (MedDRA 14.1)
536.3 (ICD-9-CM Version 2011)
E10759 (CTCAE 1105E)
C0854121 (UMLS CUI 2011AA)
10061173 (MedDRA 14.1)
Use of active medical device (either implantable or external) such as ICD, pacemaker, drug infusion device, or neurostimulator (either implantable or worn)
Item
Use of active medical device (either implantable or external) such as ICD, pacemaker, drug infusion device, or neurostimulator (either implantable or worn)
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0025080 (UMLS CUI 2011AA)
63653004 (SNOMED CT 2011_0131)
MTHU032523 (LOINC Version 232)
C0162589 (UMLS CUI 2011AA)
72506001 (SNOMED CT 2011_0131)
C0030163 (UMLS CUI 2011AA)
14106009 (SNOMED CT 2011_0131)
MTHU024521 (LOINC Version 232)
C0013187 (UMLS CUI 2011AA)
C0582124 (UMLS CUI 2011AA)
25937001 (SNOMED CT 2011_0131)
Subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.
Item
Subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.
boolean
C1516879 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0870186 (UMLS CUI 2011AA)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
CL381648 (UMLS CUI 2011AA)
Cardiac history that physician feels should exclude the subject from the study.
Item
Cardiac history that physician feels should exclude the subject from the study.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C0031831 (UMLS CUI 2011AA)
309343006 (SNOMED CT 2011_0131)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
CL411789 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Use of another investigational device agent in the 30 days prior to enrollment
Item
Use of another investigational device agent in the 30 days prior to enrollment
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C2346570 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
A history of life threatening disease within 5 years of enrollment
Item
A history of life threatening disease within 5 years of enrollment
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C2826244 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Change in diabetic medication from between visit 1 and visit 3
Item
Change in diabetic medication from between visit 1 and visit 3
boolean
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
C0580105 (UMLS CUI 2011AA)
182838006 (SNOMED CT 2011_0131)
CL426201 (UMLS CUI 2011AA)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C1550557 (UMLS CUI 2011AA)
AND (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
Any additional condition(S) that in the investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study
Item
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
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
CL414898 (UMLS CUI 2011AA)
C0681850 (UMLS CUI 2011AA)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)