ID

28929

Beschreibung

Prevention of Diabetes and Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00456963

Link

https://clinicaltrials.gov/show/NCT00456963

Stichworte

Versionen (1)
  1. 17.02.18 17.02.18 -
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See clinicaltrials.gov

Hochgeladen am

17. Februar 2018

DOI

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Eligibility Diabetes Mellitus NCT00456963

Englisch

Eligibility Diabetes Mellitus NCT00456963

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women of any racial background
Beschreibung

Racial group Any

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C1552551
age >= 40 years and <= 75 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
sbp>= 130 mmhg and < 140 mmhg or dbp >= 85 mmhg and < 90 mmhg, average of screening and randomisation visits (in absence of any antihypertensive medication)
Beschreibung

Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C0332197
fg >=100 mg/dl (5.6 mmol/l) and < 126 mg/dl (7.0 mmol/l) between screening and randomisation (in absence of any antidiabetic medication)
Beschreibung

Glucose measurement, fasting | Antidiabetics Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0202045
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C0332197
waist circumference >= 102 cm in men and >= 88 cm in women.
Beschreibung

Waist Circumference | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0455829
UMLS CUI [2]
C0079399
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
sbp >= 140 mmhg or dbp >= 90 mmhg
Beschreibung

Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
any antihypertensive, antidiabetic or antiobesity medication at the time of or during the 6 months previous to randomisation
Beschreibung

Antihypertensive Agents | Antidiabetics | Anti-Obesity Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0003364
UMLS CUI [2]
C0935929
UMLS CUI [3]
C0376607
any current or previous cardiovascular or renal disease requiring continuous administration of ds, ßbs, aceis, arbs, cas, and any other antihypertensive medication
Beschreibung

Cardiovascular Diseases | Kidney Diseases | Requirement Adrenergic beta-1 Receptor Antagonists | Requirement Angiotensin-Converting Enzyme Inhibitors | Requirement Angiotensin II receptor antagonistantagonist | Requirement Antihypertensive Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0022658
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0304516
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0003015
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C0521942
UMLS CUI [6,1]
C1514873
UMLS CUI [6,2]
C0003364
any medical condition preventing adherence to lifestyle measures included in the protocol
Beschreibung

Medical condition Preventing Adherence Lifestyle Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C1510802
UMLS CUI [1,4]
C1517876
hepatic disease as ast (sgot) or alt (sgpt) values equal or greater than two times the upper limit of normal
Beschreibung

Liver diseases | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
chronic renal dysfunction as serum creatinine > 2.0 mg/dl
Beschreibung

Renal dysfunction chronic | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3279454
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0201976
any gastrointestinal disorder interfering with drug absorption
Beschreibung

Gastrointestinal Disease Interferes with Drug absorption

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0678745
known allergy or contraindications to aceis or arbs
Beschreibung

Angiotensin-converting-enzyme inhibitor allergy | Medical contraindication Angiotensin-Converting Enzyme Inhibitors | Allergy to angiotensin II receptor antagonist | Medical contraindication Angiotensin II receptor antagonist

Datentyp

boolean

Alias
UMLS CUI [1]
C0571939
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0003015
UMLS CUI [3]
C2585204
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0521942
pregnant or lactating women; women in reproductive age not using recognized contraceptive methods
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
malignancy within the last 5 years
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
clinically significant autoimmune disorders
Beschreibung

Autoimmune Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
drug abuse or alcohol abuse within the last 5 years
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
history of noncompliance to medical regimens
Beschreibung

Protocol Compliance Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0332268
incapacity or unwillingness to sign the informed consent
Beschreibung

Informed Consent Unable | Informed Consent Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
participation in any investigational clinical trial within the last 3 months
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligibility Diabetes Mellitus NCT00456963

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Racial group Any
Item
men or women of any racial background
boolean
C0034510 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Age
Item
age >= 40 years and <= 75 years
boolean
C0001779 (UMLS CUI [1])
Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents Absent
Item
sbp>= 130 mmhg and < 140 mmhg or dbp >= 85 mmhg and < 90 mmhg, average of screening and randomisation visits (in absence of any antihypertensive medication)
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0003364 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Glucose measurement, fasting | Antidiabetics Absent
Item
fg >=100 mg/dl (5.6 mmol/l) and < 126 mg/dl (7.0 mmol/l) between screening and randomisation (in absence of any antidiabetic medication)
boolean
C0202045 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Waist Circumference | Gender
Item
waist circumference >= 102 cm in men and >= 88 cm in women.
boolean
C0455829 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Systolic Pressure | Diastolic blood pressure
Item
sbp >= 140 mmhg or dbp >= 90 mmhg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Antihypertensive Agents | Antidiabetics | Anti-Obesity Agents
Item
any antihypertensive, antidiabetic or antiobesity medication at the time of or during the 6 months previous to randomisation
boolean
C0003364 (UMLS CUI [1])
C0935929 (UMLS CUI [2])
C0376607 (UMLS CUI [3])
Cardiovascular Diseases | Kidney Diseases | Requirement Adrenergic beta-1 Receptor Antagonists | Requirement Angiotensin-Converting Enzyme Inhibitors | Requirement Angiotensin II receptor antagonistantagonist | Requirement Antihypertensive Agents
Item
any current or previous cardiovascular or renal disease requiring continuous administration of ds, ßbs, aceis, arbs, cas, and any other antihypertensive medication
boolean
C0007222 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0304516 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0003015 (UMLS CUI [4,2])
C1514873 (UMLS CUI [5,1])
C0521942 (UMLS CUI [5,2])
C1514873 (UMLS CUI [6,1])
C0003364 (UMLS CUI [6,2])
Medical condition Preventing Adherence Lifestyle Therapy
Item
any medical condition preventing adherence to lifestyle measures included in the protocol
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1510802 (UMLS CUI [1,3])
C1517876 (UMLS CUI [1,4])
Liver diseases | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
hepatic disease as ast (sgot) or alt (sgpt) values equal or greater than two times the upper limit of normal
boolean
C0023895 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Renal dysfunction chronic | Creatinine measurement, serum
Item
chronic renal dysfunction as serum creatinine > 2.0 mg/dl
boolean
C3279454 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
Gastrointestinal Disease Interferes with Drug absorption
Item
any gastrointestinal disorder interfering with drug absorption
boolean
C0017178 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
Angiotensin-converting-enzyme inhibitor allergy | Medical contraindication Angiotensin-Converting Enzyme Inhibitors | Allergy to angiotensin II receptor antagonist | Medical contraindication Angiotensin II receptor antagonist
Item
known allergy or contraindications to aceis or arbs
boolean
C0571939 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0003015 (UMLS CUI [2,2])
C2585204 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0521942 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
pregnant or lactating women; women in reproductive age not using recognized contraceptive methods
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Malignant Neoplasms
Item
malignancy within the last 5 years
boolean
C0006826 (UMLS CUI [1])
Autoimmune Diseases
Item
clinically significant autoimmune disorders
boolean
C0004364 (UMLS CUI [1])
Substance Use Disorders
Item
drug abuse or alcohol abuse within the last 5 years
boolean
C0038586 (UMLS CUI [1])
Protocol Compliance Lacking
Item
history of noncompliance to medical regimens
boolean
C0525058 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Informed Consent Unable | Informed Consent Unwilling
Item
incapacity or unwillingness to sign the informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Study Subject Participation Status
Item
participation in any investigational clinical trial within the last 3 months
boolean
C2348568 (UMLS CUI [1])
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