ID

32676

Beskrivning

The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study; ODM derived from: https://clinicaltrials.gov/show/NCT00547482

Länk

https://clinicaltrials.gov/show/NCT00547482

Nyckelord

Versioner (1)
  1. 2018-11-12 2018-11-12 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

12 november 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00547482

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT00547482

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. body mass index (bmi) ≥ 28 and ≤ 45 (kg/m2)
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
2. type 2 diabetes >6 months
Beskrivning

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
3. type 2 diabetic subjects treated with oral anti-diabetic
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
4. stable anti-diabetic medications ≥3 months prior to enrollment, six months for tzd
Beskrivning

Antidiabetics Stable | Thiazolidinediones

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C1257987
5. hba1c ≥7.5% and ≤ 9.5 % at visit 1, subjects with t2dm duration > 10 yrs should have hba1c ≥7.5% and ≤ 9.0
Beskrivning

Hemoglobin A1c measurement | Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0872146
6. stable hba1c, stable weight, and stable treatment with anti-hypertensive and/or lipids lowering medications
Beskrivning

Glycosylated hemoglobin A Stable | Stable body weight | Antihypertensive Agents Stable | Hypolipidemic Agents Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0517386
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C0205360
UMLS CUI [4,1]
C0086440
UMLS CUI [4,2]
C0205360
7. fasting blood glucose >120 and < 240 mg/dl at visit 1, subjects with t2dm duration > 10 yrs should be >120 and ≤180.
Beskrivning

Fasting blood glucose measurement | Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0428568
UMLS CUI [2]
C0011860
8. women with childbearing potential must agree to use adequate birth control methods
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
9. stable weight - no significant change (variation < 5%) in the last 6 months
Beskrivning

Stable body weight | Body Weight Variation Percentage

Datatyp

boolean

Alias
UMLS CUI [1]
C0517386
UMLS CUI [2,1]
C0005910
UMLS CUI [2,2]
C0205419
UMLS CUI [2,3]
C0439165
10. willingness to perform at least 4 capillary blood glucose tests per day twice a week for the duration of the study
Beskrivning

Blood glucose test capillary times/day times/week

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392201
UMLS CUI [1,2]
C0006901
UMLS CUI [1,3]
C0439511
UMLS CUI [1,4]
C0456698
11. willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of the trial
Beskrivning

Avoidance Weight-Loss Agents | Avoidance Weight-Loss Agents over-the-counter | Avoidance HERBAL WEIGHT LOSS AID

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0376606
UMLS CUI [2,1]
C0870186
UMLS CUI [2,2]
C0376606
UMLS CUI [2,3]
C0013231
UMLS CUI [3,1]
C0870186
UMLS CUI [3,2]
C1572271
12. ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the tantalus ii system
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
13. alert, mentally competent,
Beskrivning

Mentally alert | Competence

Datatyp

boolean

Alias
UMLS CUI [1]
C0424536
UMLS CUI [2]
C0086035
14. able to provide voluntary informed consent and hipaa authorization
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. receiving insulin therapy
Beskrivning

Insulin regime

Datatyp

boolean

Alias
UMLS CUI [1]
C0557978
2. taking glp-1, amylin treatment (byetta, symlin)
Beskrivning

GLP-1 | Amylin | Byetta | Symlin

Datatyp

boolean

Alias
UMLS CUI [1]
C0061355
UMLS CUI [2]
C0063684
UMLS CUI [3]
C1636686
UMLS CUI [4]
C1174780
3. blood pressure levels of >180/100
Beskrivning

Blood pressure determination

Datatyp

boolean

Alias
UMLS CUI [1]
C0005824
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
Beskrivning

Cardiac ejection fraction | Indication ICD | Echocardiography Required

Datatyp

boolean

Alias
UMLS CUI [1]
C0232174
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0162589
UMLS CUI [3,1]
C0013516
UMLS CUI [3,2]
C1514873
5. taking medications known to affect gastric motility such as narcotics (chronic use) and anticholinergics/antispasmodics
Beskrivning

Pharmaceutical Preparations Affecting Gastric motility | Narcotics chronic | Anticholinergic Agents | Antispasmodics

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0232572
UMLS CUI [2,1]
C0027415
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0242896
UMLS CUI [4]
C0037766
6. use of prescription, over the counter or herbal weight loss products or obesity drugs during the two months prior to enrollment
Beskrivning

Weight-Loss Agents | Weight-Loss Agents over-the-counter | HERBAL WEIGHT LOSS AID | Anti-Obesity Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2,1]
C0376606
UMLS CUI [2,2]
C0013231
UMLS CUI [3]
C1572271
UMLS CUI [4]
C0376607
7. experiencing severe and progressing diabetic complications (i.e. retinopathy not stabilized, nephropathy with macroalbuminuria)
Beskrivning

Complications of Diabetes Mellitus Severe Progressing | Diabetic Retinopathy Unstable | Kidney Disease With Macroalbuminuria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205329
UMLS CUI [2,1]
C0011884
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0332287
UMLS CUI [3,3]
C1654921
8. prior wound healing problems due to staphylococcus and candida
Beskrivning

Wound Healing Problem Due to Staphylococcus | Wound Healing Problem Due to Candida

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0043240
UMLS CUI [1,2]
C0033213
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0038170
UMLS CUI [2,1]
C0043240
UMLS CUI [2,2]
C0033213
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0006836
9. prior bariatric surgery
Beskrivning

Bariatric Surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C1456587
10. history of pancreatitis
Beskrivning

Pancreatitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0030305
11. history of peptic ulcer disease within 5 years of enrollment
Beskrivning

Peptic Ulcer

Datatyp

boolean

Alias
UMLS CUI [1]
C0030920
12. diagnosed with gastroparesis
Beskrivning

Gastroparesis

Datatyp

boolean

Alias
UMLS CUI [1]
C0152020
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.
Beskrivning

Implants | Medical Devices External | ICD | Artificial cardiac pacemaker | Implantable Neurostimulators | Neurostimulator

Datatyp

boolean

Alias
UMLS CUI [1]
C0021102
UMLS CUI [2,1]
C0025080
UMLS CUI [2,2]
C0205101
UMLS CUI [3]
C0162589
UMLS CUI [4]
C0030163
UMLS CUI [5]
C2048402
UMLS CUI [6]
C0582124
14. cardiac history that physician feels should exclude the patient
Beskrivning

Heart Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
15. use of another investigational device or agent in the 30 days prior to enrollment
Beskrivning

Investigational Medical Device | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2346570
UMLS CUI [2]
C0013230
16. a history of life-threatening disease within 5 years of enrollment
Beskrivning

Disease Life Threatening

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826244
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
Beskrivning

Condition Study Subject Participation Status Exclusion | Patient condition Preventing Completion of clinical trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C0683521
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C2732579
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00547482

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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