ID

37405

Description

Effects of Incretin on the Blood Pressure and Lipid in Patients With Overweight or Obese Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02503943

Link

https://clinicaltrials.gov/show/NCT02503943

Keywords

Versions (1)
  1. 7/23/19 7/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02503943

English

Eligibility Type 2 Diabetes NCT02503943

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female, age between 35-60 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
3. 24kg/m²≤bmi≤32kg/m², or wc≥90cm for male and wc≥85cm for female
Description

Body mass index | Waist Circumference | Gender

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0455829
UMLS CUI [3]
C0079399
4. grade 1 hypertension or masked hypertension diagnosed via 24-h ambulatory blood pressure monitoring (daytime blood pressure load 50%≥135/85 mmhg, night time blood pressure load 50%≥125/75 mmhg or 24h blood pressure load 50%≥130/80 mmhg）
Description

Hypertensive disease Grade | Masked Hypertension | 24-hour ambulatory blood pressure monitoring | Blood pressure determination Daytime | Blood pressure determination Night time | 24 hour blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0441800
UMLS CUI [2]
C3178811
UMLS CUI [3]
C2022220
UMLS CUI [4,1]
C0005824
UMLS CUI [4,2]
C0332169
UMLS CUI [5,1]
C0005824
UMLS CUI [5,2]
C0240526
UMLS CUI [6]
C1282173
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage iv diabetic nephropathy, or acute diabetic complications.
Description

Non-Insulin-Dependent Diabetes Mellitus Complications Serious | Diabetic Neuropathy | Diabetic Retinopathy | Diabetic Nephropathy Stage | Complications of Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C0205404
UMLS CUI [2]
C0011882
UMLS CUI [3]
C0011884
UMLS CUI [4,1]
C0011881
UMLS CUI [4,2]
C1306673
UMLS CUI [5]
C0342257
2. type 1 diabetes.
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
3. diagnosed moderate to severe sleep apnea syndrome(sas).
Description

Sleep Apnea Syndrome Moderate | Sleep Apnea Syndrome Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0037315
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0037315
UMLS CUI [2,2]
C0205082
4. grade 2 or grade 3 hypertension.
Description

Hypertensive disease Grade

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0441800
5. triglyceride≥5.65mmol/l
Description

Triglycerides measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202236
6. history of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
Description

Event Cardiovascular | Event Cerebrovascular | Congestive heart failure | Myocardial Infarction | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C3887460
UMLS CUI [2,1]
C0441471
UMLS CUI [2,2]
C1880018
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0038454
7. hypohepatia (ast or ast is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
Description

Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased | Hepatitis | Liver Cirrhosis | Hepatic Encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0019158
UMLS CUI [5]
C0023890
UMLS CUI [6]
C0019151
8. renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
Description

Renal Insufficiency | Serum creatinine raised | Dialysis | Nephritic syndrome

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0700225
UMLS CUI [3]
C0011946
UMLS CUI [4]
C0268732
9. chronic obstructive pulmonary disease (copd), chronic respiratory failure or hyoxemia.
Description

Chronic Obstructive Airway Disease | Chronic respiratory failure | Hypoxemia

Data type

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0264492
UMLS CUI [3]
C0700292
10. acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
Description

Communicable Diseases | Neoplasms | Cardiac Arrhythmia Severe | Mental disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0027651
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0004936
UMLS CUI [5]
C0038580
11. fertile woman without contraceptives.
Description

Childbearing Potential Contraceptive Agents Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0009871
UMLS CUI [1,3]
C0332197
12. any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
Description

Operative Surgical Procedures Influence Absorption Investigational New Drugs | Operative Surgical Procedures Influence Distribution Investigational New Drugs | Operative Surgical Procedures Influence Metabolism Investigational New Drugs | Operative Surgical Procedures Influence Excretion Investigational New Drugs | Medical condition Influence Absorption Investigational New Drugs | Medical condition Influence Distribution Investigational New Drugs | Medical condition Influence Metabolism Investigational New Drugs | Medical condition Influence Excretion Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C1378698
UMLS CUI [2,4]
C0013230
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C4054723
UMLS CUI [3,3]
C0025519
UMLS CUI [3,4]
C0013230
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C4054723
UMLS CUI [4,3]
C0221102
UMLS CUI [4,4]
C0013230
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C4054723
UMLS CUI [5,3]
C0237442
UMLS CUI [5,4]
C0013230
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C4054723
UMLS CUI [6,3]
C1378698
UMLS CUI [6,4]
C0013230
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C4054723
UMLS CUI [7,3]
C0025519
UMLS CUI [7,4]
C0013230
UMLS CUI [8,1]
C3843040
UMLS CUI [8,2]
C4054723
UMLS CUI [8,3]
C0221102
UMLS CUI [8,4]
C0013230
13. allergic to or have contraindication to the intervention drugs.
Description

Hypersensitivity Investigational New Drugs | Medical contraindication Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0013230
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Similar models

Eligibility Type 2 Diabetes NCT02503943

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male or female, age between 35-60 years old
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
2. type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Body mass index | Waist Circumference | Gender
Item
3. 24kg/m²≤bmi≤32kg/m², or wc≥90cm for male and wc≥85cm for female
boolean
C1305855 (UMLS CUI [1])
C0455829 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Hypertensive disease Grade | Masked Hypertension | 24-hour ambulatory blood pressure monitoring | Blood pressure determination Daytime | Blood pressure determination Night time | 24 hour blood pressure
Item
4. grade 1 hypertension or masked hypertension diagnosed via 24-h ambulatory blood pressure monitoring (daytime blood pressure load 50%≥135/85 mmhg, night time blood pressure load 50%≥125/75 mmhg or 24h blood pressure load 50%≥130/80 mmhg）
boolean
C0020538 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C3178811 (UMLS CUI [2])
C2022220 (UMLS CUI [3])
C0005824 (UMLS CUI [4,1])
C0332169 (UMLS CUI [4,2])
C0005824 (UMLS CUI [5,1])
C0240526 (UMLS CUI [5,2])
C1282173 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Complications Serious | Diabetic Neuropathy | Diabetic Retinopathy | Diabetic Nephropathy Stage | Complications of Diabetes Mellitus
Item
1. type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage iv diabetic nephropathy, or acute diabetic complications.
boolean
C0011860 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0011882 (UMLS CUI [2])
C0011884 (UMLS CUI [3])
C0011881 (UMLS CUI [4,1])
C1306673 (UMLS CUI [4,2])
C0342257 (UMLS CUI [5])
Diabetes Mellitus, Insulin-Dependent
Item
2. type 1 diabetes.
boolean
C0011854 (UMLS CUI [1])
Sleep Apnea Syndrome Moderate | Sleep Apnea Syndrome Severe
Item
3. diagnosed moderate to severe sleep apnea syndrome(sas).
boolean
C0037315 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0037315 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Hypertensive disease Grade
Item
4. grade 2 or grade 3 hypertension.
boolean
C0020538 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Triglycerides measurement
Item
5. triglyceride≥5.65mmol/l
boolean
C0202236 (UMLS CUI [1])
Event Cardiovascular | Event Cerebrovascular | Congestive heart failure | Myocardial Infarction | Cerebrovascular accident
Item
6. history of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
boolean
C0441471 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
C0441471 (UMLS CUI [2,1])
C1880018 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased | Hepatitis | Liver Cirrhosis | Hepatic Encephalopathy
Item
7. hypohepatia (ast or ast is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
boolean
C0086565 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0019158 (UMLS CUI [4])
C0023890 (UMLS CUI [5])
C0019151 (UMLS CUI [6])
Renal Insufficiency | Serum creatinine raised | Dialysis | Nephritic syndrome
Item
8. renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
boolean
C1565489 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
C0268732 (UMLS CUI [4])
Chronic Obstructive Airway Disease | Chronic respiratory failure | Hypoxemia
Item
9. chronic obstructive pulmonary disease (copd), chronic respiratory failure or hyoxemia.
boolean
C0024117 (UMLS CUI [1])
C0264492 (UMLS CUI [2])
C0700292 (UMLS CUI [3])
Communicable Diseases | Neoplasms | Cardiac Arrhythmia Severe | Mental disorders | Substance Dependence
Item
10. acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
boolean
C0009450 (UMLS CUI [1])
C0027651 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0004936 (UMLS CUI [4])
C0038580 (UMLS CUI [5])
Childbearing Potential Contraceptive Agents Absent
Item
11. fertile woman without contraceptives.
boolean
C3831118 (UMLS CUI [1,1])
C0009871 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Operative Surgical Procedures Influence Absorption Investigational New Drugs | Operative Surgical Procedures Influence Distribution Investigational New Drugs | Operative Surgical Procedures Influence Metabolism Investigational New Drugs | Operative Surgical Procedures Influence Excretion Investigational New Drugs | Medical condition Influence Absorption Investigational New Drugs | Medical condition Influence Distribution Investigational New Drugs | Medical condition Influence Metabolism Investigational New Drugs | Medical condition Influence Excretion Investigational New Drugs
Item
12. any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
boolean
C0543467 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0543467 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C1378698 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C0543467 (UMLS CUI [3,1])
C4054723 (UMLS CUI [3,2])
C0025519 (UMLS CUI [3,3])
C0013230 (UMLS CUI [3,4])
C0543467 (UMLS CUI [4,1])
C4054723 (UMLS CUI [4,2])
C0221102 (UMLS CUI [4,3])
C0013230 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C4054723 (UMLS CUI [5,2])
C0237442 (UMLS CUI [5,3])
C0013230 (UMLS CUI [5,4])
C3843040 (UMLS CUI [6,1])
C4054723 (UMLS CUI [6,2])
C1378698 (UMLS CUI [6,3])
C0013230 (UMLS CUI [6,4])
C3843040 (UMLS CUI [7,1])
C4054723 (UMLS CUI [7,2])
C0025519 (UMLS CUI [7,3])
C0013230 (UMLS CUI [7,4])
C3843040 (UMLS CUI [8,1])
C4054723 (UMLS CUI [8,2])
C0221102 (UMLS CUI [8,3])
C0013230 (UMLS CUI [8,4])
Hypersensitivity Investigational New Drugs | Medical contraindication Investigational New Drugs
Item
13. allergic to or have contraindication to the intervention drugs.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
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