ID

20744

Beskrivning

Neuroendocrine Brake for Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00450710

Länk

https://clinicaltrials.gov/show/NCT00450710

Nyckelord

Versioner (1)
  1. 2017-03-14 2017-03-14 -
Uppladdad den

14 mars 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes NCT00450710

Engelsk

Eligibility Diabetes NCT00450710

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00450710
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. - male and female between 18 and 65 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. bmi 25.1 - 34.9.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
3. type 2 diabetic patients on oral anti-diabetic agents and/or insulin treatment for a minimum of 12 months prior the enrollment.
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral | Insulin regime

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C0557978
4. diagnosis of t2dm for at least 3 years.
Beskrivning

Non-Insulin-Dependent Diabetes Mellitus disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
5. patient has been under routine care of hte study physician or another physician that can supply a reliable medical record for at least 3 years.
Beskrivning

patient care Routine supply Medical Record

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0017313
UMLS CUI [1,2]
C0205547
UMLS CUI [1,3]
C0243163
UMLS CUI [1,4]
C0025102
6. hba1c >/ 7.5 documented for at least 3 months.
Beskrivning

Glucohemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202054
7. stable weight (nor significant weight change (>3%) over the 3 months prior to enrollment.
Beskrivning

Stable body weight | Body Weight unchanged

Datatyp

boolean

Alias
UMLS CUI [1]
C0517386
UMLS CUI [2,1]
C0005910
UMLS CUI [2,2]
C0442739
8. stable medication for at least one month prior to enrollment except for diabetes medications which should be stable for at least 3 months prior to enrollment.
Beskrivning

Pharmaceutical Preparations Stable | Antidiabetics Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C0205360
9. ability and willingness to return for all scheduled visits and participate in recommended parameter setting and physician recommended medical/laboratory assessments.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior abdominal surgery, except laparoscopic cholecystectomy.
Beskrivning

ABDOMINAL SURGERY, PAST | Cholecystectomy, Laparoscopic

Datatyp

boolean

Alias
UMLS CUI [1]
C0238564
UMLS CUI [2]
C0162522
2. taking appetite suppressant.
Beskrivning

Appetite Depressants

Datatyp

boolean

Alias
UMLS CUI [1]
C0003620
3. severe eating disorders.
Beskrivning

Eating Disorders Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013473
UMLS CUI [1,2]
C0205082
4. severe pulmonary, renal or cardiac disease.
Beskrivning

Lung disease Severe | Kidney Disease Severe | Heart Disease Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0205082
5. obese due to a clinically diagnosed endocrine disorder.
Beskrivning

Obesity Due to Endocrine System Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0028754
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0014130
6. subjects with impaired liver function.
Beskrivning

Liver Dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
7. history of peptic ulcer disease.
Beskrivning

Peptic Ulcer

Datatyp

boolean

Alias
UMLS CUI [1]
C0030920
8. history of malignant disease.
Beskrivning

Malignant Neoplasm

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
9. use of prescription, over the counter or herbal weight loss products.
Beskrivning

Weight-Loss Agents Prescription | Weight-Loss Agents OTC products | HERBAL WEIGHT LOSS AID

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0376606
UMLS CUI [1,2]
C0033080
UMLS CUI [2,1]
C0376606
UMLS CUI [2,2]
C0013231
UMLS CUI [3]
C1572271
10. pregnant or planning on pregnancy while enrolled in study.
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
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Similar models

Eligibility Diabetes NCT00450710

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00450710
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. - male and female between 18 and 65 years.
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
2. bmi 25.1 - 34.9.
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral | Insulin regime
Item
3. type 2 diabetic patients on oral anti-diabetic agents and/or insulin treatment for a minimum of 12 months prior the enrollment.
boolean
C0011860 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0557978 (UMLS CUI [3])
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
4. diagnosis of t2dm for at least 3 years.
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
patient care Routine supply Medical Record
Item
5. patient has been under routine care of hte study physician or another physician that can supply a reliable medical record for at least 3 years.
boolean
C0017313 (UMLS CUI [1,1])
C0205547 (UMLS CUI [1,2])
C0243163 (UMLS CUI [1,3])
C0025102 (UMLS CUI [1,4])
Glucohemoglobin measurement
Item
6. hba1c >/ 7.5 documented for at least 3 months.
boolean
C0202054 (UMLS CUI [1])
Stable body weight | Body Weight unchanged
Item
7. stable weight (nor significant weight change (>3%) over the 3 months prior to enrollment.
boolean
C0517386 (UMLS CUI [1])
C0005910 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
Pharmaceutical Preparations Stable | Antidiabetics Stable
Item
8. stable medication for at least one month prior to enrollment except for diabetes medications which should be stable for at least 3 months prior to enrollment.
boolean
C0013227 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Protocol Compliance
Item
9. ability and willingness to return for all scheduled visits and participate in recommended parameter setting and physician recommended medical/laboratory assessments.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ABDOMINAL SURGERY, PAST | Cholecystectomy, Laparoscopic
Item
1. prior abdominal surgery, except laparoscopic cholecystectomy.
boolean
C0238564 (UMLS CUI [1])
C0162522 (UMLS CUI [2])
Appetite Depressants
Item
2. taking appetite suppressant.
boolean
C0003620 (UMLS CUI [1])
Eating Disorders Severe
Item
3. severe eating disorders.
boolean
C0013473 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Lung disease Severe | Kidney Disease Severe | Heart Disease Severe
Item
4. severe pulmonary, renal or cardiac disease.
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Obesity Due to Endocrine System Disease
Item
5. obese due to a clinically diagnosed endocrine disorder.
boolean
C0028754 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0014130 (UMLS CUI [1,3])
Liver Dysfunction
Item
6. subjects with impaired liver function.
boolean
C0086565 (UMLS CUI [1])
Peptic Ulcer
Item
7. history of peptic ulcer disease.
boolean
C0030920 (UMLS CUI [1])
Malignant Neoplasm
Item
8. history of malignant disease.
boolean
C0006826 (UMLS CUI [1])
Weight-Loss Agents Prescription | Weight-Loss Agents OTC products | HERBAL WEIGHT LOSS AID
Item
9. use of prescription, over the counter or herbal weight loss products.
boolean
C0376606 (UMLS CUI [1,1])
C0033080 (UMLS CUI [1,2])
C0376606 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C1572271 (UMLS CUI [3])
Pregnancy | Pregnancy, Planned
Item
10. pregnant or planning on pregnancy while enrolled in study.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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