ID

32993

Descripción

Effect Of Exenatide Treatment on Liver Fat Content in Patients With Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01432405

Link

https://clinicaltrials.gov/show/NCT01432405

Palabras clave

Versiones (1)
  1. 22/11/18 22/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

22 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT01432405

Inglés

Eligibility Type 2 Diabetes Mellitus NCT01432405

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must range in age from 30 to 70 years.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
Descripción

Able to communicate Research Personnel | Competence Legal Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0035173
UMLS CUI [2,1]
C0086035
UMLS CUI [2,2]
C1301860
UMLS CUI [2,3]
C0021430
3. patients may be of either sex. female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions or be surgically sterilized.
Descripción

Gender | Breast Feeding Absent | Postmenopausal state Duration | Gender Contraceptive methods | Female Sterilization

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0232970
UMLS CUI [3,2]
C0449238
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [5]
C0015787
4. patients must meet the american diabetes association criteria for diagnosis of type 2 diabetes mellitus.
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
5. patients must be on diet therapy alone and/or metformin treatment (stable dose) and have a fasting plasma glucose concentration between 126 and 260 mg/dl.
Descripción

Diet therapy | Metformin Dose Stable | Plasma fasting glucose measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0583513
6. patients must have hematocrit greater than 34%.
Descripción

Hematocrit level

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518014
7. subjects whose body weight has been stable (±1 kg) over the three months prior to study will be included.
Descripción

Stable body weight Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0517386
UMLS CUI [1,2]
C0449238
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1, type 1 diabetes.
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
2. fasting plasma glucose greater than 260 mg/dl.
Descripción

Plasma fasting glucose measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0583513
3. patients must not have received a thiazolidinedione for at least 3 months prior to randomization.
Descripción

Thiazolidinediones

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1257987
4. patients must not be on insulin treatment or have received insulin for more than one week within the previous year prior to entry. patients should not be on sulfonylureas, sitagliptin, or exenatide treatment.
Descripción

Insulin regime | Insulin | Sulfonylurea | sitagliptin | exenatide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2]
C0021641
UMLS CUI [3]
C0038766
UMLS CUI [4]
C1565750
UMLS CUI [5]
C0167117
5. patients taking systemic glucocorticoids or other medications known to affect glucose tolerance are excluded.
Descripción

Glucocorticoids, Systemic | Pharmaceutical Preparations Affecting Glucose tolerance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3540777
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0178665
6. patients taking medications that affect gastrointestinal motility will be excluded
Descripción

Pharmaceutical Preparations Affecting Gastrointestinal Motility

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0017184
7. patients with a history of chf, or clinically significant cardiac, liver or kidney disease (creatinine greater than 1.8 mg/dl).
Descripción

Congestive heart failure | Heart Disease | Liver disease | Kidney Disease | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0201976
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT01432405

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patients must range in age from 30 to 70 years.
boolean
C0001779 (UMLS CUI [1])
Able to communicate Research Personnel | Competence Legal Informed Consent
Item
2. patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
boolean
C2364293 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0086035 (UMLS CUI [2,1])
C1301860 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
Gender | Breast Feeding Absent | Postmenopausal state Duration | Gender Contraceptive methods | Female Sterilization
Item
3. patients may be of either sex. female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions or be surgically sterilized.
boolean
C0079399 (UMLS CUI [1])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0015787 (UMLS CUI [5])
Diabetes Mellitus, Non-Insulin-Dependent
Item
4. patients must meet the american diabetes association criteria for diagnosis of type 2 diabetes mellitus.
boolean
C0011860 (UMLS CUI [1])
Diet therapy | Metformin Dose Stable | Plasma fasting glucose measurement
Item
5. patients must be on diet therapy alone and/or metformin treatment (stable dose) and have a fasting plasma glucose concentration between 126 and 260 mg/dl.
boolean
C0012159 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0583513 (UMLS CUI [3])
Hematocrit level
Item
6. patients must have hematocrit greater than 34%.
boolean
C0518014 (UMLS CUI [1])
Stable body weight Duration
Item
7. subjects whose body weight has been stable (±1 kg) over the three months prior to study will be included.
boolean
C0517386 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
1, type 1 diabetes.
boolean
C0011854 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
2. fasting plasma glucose greater than 260 mg/dl.
boolean
C0583513 (UMLS CUI [1])
Thiazolidinediones
Item
3. patients must not have received a thiazolidinedione for at least 3 months prior to randomization.
boolean
C1257987 (UMLS CUI [1])
Insulin regime | Insulin | Sulfonylurea | sitagliptin | exenatide
Item
4. patients must not be on insulin treatment or have received insulin for more than one week within the previous year prior to entry. patients should not be on sulfonylureas, sitagliptin, or exenatide treatment.
boolean
C0557978 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
C0038766 (UMLS CUI [3])
C1565750 (UMLS CUI [4])
C0167117 (UMLS CUI [5])
Glucocorticoids, Systemic | Pharmaceutical Preparations Affecting Glucose tolerance
Item
5. patients taking systemic glucocorticoids or other medications known to affect glucose tolerance are excluded.
boolean
C3540777 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0178665 (UMLS CUI [2,3])
Pharmaceutical Preparations Affecting Gastrointestinal Motility
Item
6. patients taking medications that affect gastrointestinal motility will be excluded
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0017184 (UMLS CUI [1,3])
Congestive heart failure | Heart Disease | Liver disease | Kidney Disease | Creatinine measurement, serum
Item
7. patients with a history of chf, or clinically significant cardiac, liver or kidney disease (creatinine greater than 1.8 mg/dl).
boolean
C0018802 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
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