Eligibility Type 2 Diabetes Mellitus NCT00547482

1 moduli

StudyEvent: Eligibility
1. Eligibility Type 2 Diabetes Mellitus NCT00547482

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Inclusion Criteria

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])

Exclusion Criteria

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])

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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Eligibility Type 2 Diabetes Mellitus NCT00547482