ID

31514

Description

Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass; ODM derived from: https://clinicaltrials.gov/show/NCT00775684

Link

https://clinicaltrials.gov/show/NCT00775684

Keywords

Versions (1)
  1. 8/31/18 8/31/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 31, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Pre-diabetes NCT00775684

English

Eligibility Pre-diabetes NCT00775684

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and female patients age 18 to 70 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. ability to provide written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
3. mentally stable and able to comply with the procedures of the study protocol
Description

Mental state Stable | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0278060
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0525058
4. clinical history compatible with impaired fasting glucose or early t2d as defined by a plasma glucose concentration between 110-159 mg/dl following a 12 hour overnight fast performed off any anti-diabetogenic agent for at least 2 weeks (6 weeks for thiazolidinediones)
Description

History of clinical finding Consistent with Impaired fasting glycaemia | History of clinical finding Consistent with Non-Insulin-Dependent Diabetes Mellitus Early | Plasma Glucose Measurement | Status post Overnight Fasting | Antidiabetics Absent | Thiazolidinediones Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C2317559
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C1272092
UMLS CUI [2,1]
C2317559
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0011860
UMLS CUI [2,4]
C1279919
UMLS CUI [3]
C0202042
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0439583
UMLS CUI [4,3]
C0015663
UMLS CUI [5,1]
C0935929
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C1257987
UMLS CUI [6,2]
C0332197
5. stable body weight (+ 5%) for at least 2 weeks
Description

Stable body weight Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0517386
UMLS CUI [1,2]
C0449238
6. female patients: agree to use adequate contraception if reproductively capable. adequate contraception includes either a hormonal or barrier method, or surgical sterilization.
Description

Childbearing Potential Contraceptive methods | Hormonal contraception | Contraception, Barrier | Female Sterilization

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C2985296
UMLS CUI [3]
C0004764
UMLS CUI [4]
C0015787
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. diagnosis of type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
2. receiving insulin, exenatide (byetta®), or sitagliptin (januvia®) treatment or taking > 2 oral anti-diabetogenic agents for the treatment of diabetes
Description

Insulin | exenatide | Byetta | sitagliptin | Januvia | Antidiabetics Oral Quantity Diabetes Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0167117
UMLS CUI [3]
C1636686
UMLS CUI [4]
C1565750
UMLS CUI [5]
C1702177
UMLS CUI [6,1]
C0935929
UMLS CUI [6,2]
C1527415
UMLS CUI [6,3]
C1265611
UMLS CUI [6,4]
C3274787
3. bmi > 44 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
4. allergy to any sulfa-containing compounds
Description

Allergy to sulfonamides

Data type

boolean

Alias
UMLS CUI [1]
C0038757
5. uncontrolled hypertension (sbp >160 or dbp > 100 mmhg)
Description

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
6. uncontrolled hyperlipidemia (triglycerides > 500 or ldl > 160 mg/dl)
Description

Hyperlipidemia Uncontrolled | Triglycerides measurement | LDL cholesterol measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0020473
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0202236
UMLS CUI [3]
C0202117
7. elevation of liver function tests > 2 times the upper limit of normal
Description

Increased liver function tests

Data type

boolean

Alias
UMLS CUI [1]
C0877359
8. estimated gfr < 55 ml/min/1.73m2 (46)
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
9. hyperkalemia (serum potassium > 5.5 mmol/l)
Description

Hyperkalemia | Serum potassium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0020461
UMLS CUI [2]
C0302353
10. moderate anemia (hemoglobin concentration < 12 g/dl in men and < 11 g/dl in women)
Description

Anemia Moderate | Hemoglobin measurement | Gender

Data type

boolean

Alias
UMLS CUI [1,1]
C0002871
UMLS CUI [1,2]
C0205081
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0079399
11. female patients: pregnant or lactating
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
12. hepatic cirrhosis
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
13. known active alcohol or substance abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
14. active cardiovascular disease
Description

Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
15. use of any investigational agent within 6 weeks of the baseline visit
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
16. any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial
Description

Medical condition Interferes with Completion of clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2732579
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Similar models

Eligibility Pre-diabetes NCT00775684

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male and female patients age 18 to 70 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
2. ability to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Mental state Stable | Protocol Compliance
Item
3. mentally stable and able to comply with the procedures of the study protocol
boolean
C0278060 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
History of clinical finding Consistent with Impaired fasting glycaemia | History of clinical finding Consistent with Non-Insulin-Dependent Diabetes Mellitus Early | Plasma Glucose Measurement | Status post Overnight Fasting | Antidiabetics Absent | Thiazolidinediones Absent
Item
4. clinical history compatible with impaired fasting glucose or early t2d as defined by a plasma glucose concentration between 110-159 mg/dl following a 12 hour overnight fast performed off any anti-diabetogenic agent for at least 2 weeks (6 weeks for thiazolidinediones)
boolean
C2317559 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C1272092 (UMLS CUI [1,3])
C2317559 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0011860 (UMLS CUI [2,3])
C1279919 (UMLS CUI [2,4])
C0202042 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0439583 (UMLS CUI [4,2])
C0015663 (UMLS CUI [4,3])
C0935929 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C1257987 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Stable body weight Duration
Item
5. stable body weight (+ 5%) for at least 2 weeks
boolean
C0517386 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Hormonal contraception | Contraception, Barrier | Female Sterilization
Item
6. female patients: agree to use adequate contraception if reproductively capable. adequate contraception includes either a hormonal or barrier method, or surgical sterilization.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C2985296 (UMLS CUI [2])
C0004764 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
1. diagnosis of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Insulin | exenatide | Byetta | sitagliptin | Januvia | Antidiabetics Oral Quantity Diabetes Therapy
Item
2. receiving insulin, exenatide (byetta®), or sitagliptin (januvia®) treatment or taking > 2 oral anti-diabetogenic agents for the treatment of diabetes
boolean
C0021641 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1636686 (UMLS CUI [3])
C1565750 (UMLS CUI [4])
C1702177 (UMLS CUI [5])
C0935929 (UMLS CUI [6,1])
C1527415 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
C3274787 (UMLS CUI [6,4])
Body mass index
Item
3. bmi > 44 kg/m2
boolean
C1305855 (UMLS CUI [1])
Allergy to sulfonamides
Item
4. allergy to any sulfa-containing compounds
boolean
C0038757 (UMLS CUI [1])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
5. uncontrolled hypertension (sbp >160 or dbp > 100 mmhg)
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Hyperlipidemia Uncontrolled | Triglycerides measurement | LDL cholesterol measurement
Item
6. uncontrolled hyperlipidemia (triglycerides > 500 or ldl > 160 mg/dl)
boolean
C0020473 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0202236 (UMLS CUI [2])
C0202117 (UMLS CUI [3])
Increased liver function tests
Item
7. elevation of liver function tests > 2 times the upper limit of normal
boolean
C0877359 (UMLS CUI [1])
Estimated Glomerular Filtration Rate
Item
8. estimated gfr < 55 ml/min/1.73m2 (46)
boolean
C3811844 (UMLS CUI [1])
Hyperkalemia | Serum potassium measurement
Item
9. hyperkalemia (serum potassium > 5.5 mmol/l)
boolean
C0020461 (UMLS CUI [1])
C0302353 (UMLS CUI [2])
Anemia Moderate | Hemoglobin measurement | Gender
Item
10. moderate anemia (hemoglobin concentration < 12 g/dl in men and < 11 g/dl in women)
boolean
C0002871 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
11. female patients: pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Liver Cirrhosis
Item
12. hepatic cirrhosis
boolean
C0023890 (UMLS CUI [1])
Substance Use Disorders
Item
13. known active alcohol or substance abuse
boolean
C0038586 (UMLS CUI [1])
Cardiovascular Disease
Item
14. active cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Investigational New Drugs
Item
15. use of any investigational agent within 6 weeks of the baseline visit
boolean
C0013230 (UMLS CUI [1])
Medical condition Interferes with Completion of clinical trial
Item
16. any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
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