ID

37379

Beschreibung

Study on the Efficacy aNd Safety of Jinlida Granules in Patients With Inadequately cOntrolled tYpe-2 Diabetes and dysLIpidemia Under liFe Style Intervention (ENJOY LIFE Study); ODM derived from: https://clinicaltrials.gov/show/NCT02035644

Link

https://clinicaltrials.gov/show/NCT02035644

Stichworte

Versionen (1)
  1. 20.07.19 20.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. Juli 2019

DOI

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Eligibility Type 2 Diabetes NCT02035644

Englisch

Eligibility Type 2 Diabetes NCT02035644

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age of 20-70 years;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosed with type 2 diabetes inadequately controlled under life style intervention with 3 months before screening;
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Control Inadequate | Lifestyle Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0243148
UMLS CUI [2,2]
C0205412
UMLS CUI [3]
C1517876
3. hba1c ≥6.5% and ≤10.0%, and fasting plasma glucose ≥7 and ≤13.3mmol/l at baseline;
Beschreibung

Hemoglobin A1c measurement | Plasma fasting glucose measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2]
C0583513
4. diagnosed with dislipidemia with triglycerides>150mg/dl (1.70mmol/l), and/or total cholesterol >200mg/dl (5.16mmol/l), and/or ldl-c>100mg/dl (2.58mmol/l)
Beschreibung

Dyslipidemia | Triglycerides measurement | Serum total cholesterol measurement | Serum LDL cholesterol measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0242339
UMLS CUI [2]
C0202236
UMLS CUI [3]
C1445957
UMLS CUI [4]
C0428474
5. body mass index (bmi): 20<bmi<40 kg/m2;
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. moderate or severe liver dysfunction, abnormal renal function;
Beschreibung

Liver Dysfunction Moderate | Liver Dysfunction Severe | Abnormal renal function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0151746
2. severe dysfunction of the heart;
Beschreibung

Heart dysfunction Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0340515
UMLS CUI [1,2]
C0205082
3. histories of acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma within 3 months;
Beschreibung

Complications of Diabetes Mellitus | Diabetic Ketoacidosis | Hyperglycemic Hyperosmolar Nonketotic Coma

Datentyp

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2]
C0011880
UMLS CUI [3]
C0020457
4. psychiatric disease or severe infection;
Beschreibung

Mental disorders | Communicable Disease Severe

Datentyp

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205082
5. pregnancy or planned pregnancy;
Beschreibung

Pregnancy | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
6. use of any drug (including insulin) for treatment of diabetes or dyslipidemia within 3 months;
Beschreibung

Pharmacotherapy Diabetes Mellitus | Pharmacotherapy Dyslipidemia | Insulin regime

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0011849
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0242339
UMLS CUI [3]
C0557978
7. use of chronic (>7 days) systemic glucocorticoid therapy within 8 weeks or receive growth hormone therapy within 6 months;
Beschreibung

Glucocorticoids, Systemic | Growth hormone treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C3540777
UMLS CUI [2]
C0744483
8. diagnosed with type 1 diabetes, or gestational diabetes, or other specific types of diabetes;
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Gestational Diabetes | Diabetes Type Specific

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0085207
UMLS CUI [3,1]
C0011847
UMLS CUI [3,2]
C0332307
UMLS CUI [3,3]
C0205369
9. history of malignant tumor within 5 years.
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
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Ähnliche Modelle

Eligibility Type 2 Diabetes NCT02035644

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age of 20-70 years;
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Control Inadequate | Lifestyle Therapy
Item
2. diagnosed with type 2 diabetes inadequately controlled under life style intervention with 3 months before screening;
boolean
C0011860 (UMLS CUI [1])
C0243148 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C1517876 (UMLS CUI [3])
Hemoglobin A1c measurement | Plasma fasting glucose measurement
Item
3. hba1c ≥6.5% and ≤10.0%, and fasting plasma glucose ≥7 and ≤13.3mmol/l at baseline;
boolean
C0474680 (UMLS CUI [1])
C0583513 (UMLS CUI [2])
Dyslipidemia | Triglycerides measurement | Serum total cholesterol measurement | Serum LDL cholesterol measurement
Item
4. diagnosed with dislipidemia with triglycerides>150mg/dl (1.70mmol/l), and/or total cholesterol >200mg/dl (5.16mmol/l), and/or ldl-c>100mg/dl (2.58mmol/l)
boolean
C0242339 (UMLS CUI [1])
C0202236 (UMLS CUI [2])
C1445957 (UMLS CUI [3])
C0428474 (UMLS CUI [4])
Body mass index
Item
5. body mass index (bmi): 20<bmi<40 kg/m2;
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver Dysfunction Moderate | Liver Dysfunction Severe | Abnormal renal function
Item
1. moderate or severe liver dysfunction, abnormal renal function;
boolean
C0086565 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0151746 (UMLS CUI [3])
Heart dysfunction Severe
Item
2. severe dysfunction of the heart;
boolean
C0340515 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Complications of Diabetes Mellitus | Diabetic Ketoacidosis | Hyperglycemic Hyperosmolar Nonketotic Coma
Item
3. histories of acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma within 3 months;
boolean
C0342257 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
C0020457 (UMLS CUI [3])
Mental disorders | Communicable Disease Severe
Item
4. psychiatric disease or severe infection;
boolean
C0004936 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Pregnancy | Pregnancy, Planned
Item
5. pregnancy or planned pregnancy;
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Pharmacotherapy Diabetes Mellitus | Pharmacotherapy Dyslipidemia | Insulin regime
Item
6. use of any drug (including insulin) for treatment of diabetes or dyslipidemia within 3 months;
boolean
C0013216 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0013216 (UMLS CUI [2,1])
C0242339 (UMLS CUI [2,2])
C0557978 (UMLS CUI [3])
Glucocorticoids, Systemic | Growth hormone treatment
Item
7. use of chronic (>7 days) systemic glucocorticoid therapy within 8 weeks or receive growth hormone therapy within 6 months;
boolean
C3540777 (UMLS CUI [1])
C0744483 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent | Gestational Diabetes | Diabetes Type Specific
Item
8. diagnosed with type 1 diabetes, or gestational diabetes, or other specific types of diabetes;
boolean
C0011854 (UMLS CUI [1])
C0085207 (UMLS CUI [2])
C0011847 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
Malignant Neoplasms
Item
9. history of malignant tumor within 5 years.
boolean
C0006826 (UMLS CUI [1])
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