ID

33713

Beschreibung

Go Fish: Omega-3 Fatty Acid Supplementation in Diabetes-Related Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01092390

Link

https://clinicaltrials.gov/show/NCT01092390

Stichworte

Versionen (1)
  1. 20.12.18 20.12.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. Dezember 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes NCT01092390

Englisch

Eligibility Diabetes NCT01092390

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01092390
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants have a diagnosis of diabetes (either oral medication or diet controlled)
Beschreibung

Diabetes Mellitus | Oral medication | Dietary control

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0175795
UMLS CUI [3]
C0743195
have an average systolic blood pressure (sbp) <150 and diastolic blood pressure (dbp) <90 mmhg
Beschreibung

Systolic Pressure Average | Diastolic blood pressure Average

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C1510992
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C1510992
have quantified proteinuria -- urine albumin/creatinine ratio of > 17 mg/g (men) and >25 mg/g (women) (i.e. at least microalbuminuria).
Beschreibung

Proteinuria | Urine albumin/creatinine ratio measurement | Gender | Microalbuminuria

Datentyp

boolean

Alias
UMLS CUI [1]
C0033687
UMLS CUI [2]
C0455271
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0730345
participants must be on stable doses of antihypertensive, hypoglycemic, and lipid lowering medications for a minimum of two months prior to randomization. participants must agree to stay on stable doses of diabetes, antihypertensive and lipid medication for the duration of the study.
Beschreibung

Antihypertensive Agents Dose Stable | Hypoglycemic Agents Dose Stable | Hypolipidemic Agents Dose Stable | Antidiabetics Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0020616
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0086440
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
major exclusion criteria will be poorly controlled diabetes (hemoglobin a1c >9%)
Beschreibung

Poorly controlled diabetes mellitus | Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0554876
UMLS CUI [2]
C0474680
use of insulin
Beschreibung

Insulin use

Datentyp

boolean

Alias
UMLS CUI [1]
C0240016
use of fish oil supplements or are unwilling to stop fish oil supplements one month prior to randomization and refrain from the supplements during the study
Beschreibung

Fish Oil Supplements | Fish Oil Supplements Discontinue Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016157
UMLS CUI [1,2]
C0242295
UMLS CUI [2,1]
C0016157
UMLS CUI [2,2]
C0242295
UMLS CUI [2,3]
C1444662
UMLS CUI [2,4]
C0558080
stage 4 or stage 5 ckd or a screening urine protein/creatinine ratio of >2.5.
Beschreibung

Chronic kidney disease stage | Urine protein/creatinine ratio measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C2074731
UMLS CUI [2]
C1096054
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Ähnliche Modelle

Eligibility Diabetes NCT01092390

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01092390
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus | Oral medication | Dietary control
Item
participants have a diagnosis of diabetes (either oral medication or diet controlled)
boolean
C0011849 (UMLS CUI [1])
C0175795 (UMLS CUI [2])
C0743195 (UMLS CUI [3])
Systolic Pressure Average | Diastolic blood pressure Average
Item
have an average systolic blood pressure (sbp) <150 and diastolic blood pressure (dbp) <90 mmhg
boolean
C0871470 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
C0428883 (UMLS CUI [2,1])
C1510992 (UMLS CUI [2,2])
Proteinuria | Urine albumin/creatinine ratio measurement | Gender | Microalbuminuria
Item
have quantified proteinuria -- urine albumin/creatinine ratio of > 17 mg/g (men) and >25 mg/g (women) (i.e. at least microalbuminuria).
boolean
C0033687 (UMLS CUI [1])
C0455271 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0730345 (UMLS CUI [4])
Antihypertensive Agents Dose Stable | Hypoglycemic Agents Dose Stable | Hypolipidemic Agents Dose Stable | Antidiabetics Dose Stable
Item
participants must be on stable doses of antihypertensive, hypoglycemic, and lipid lowering medications for a minimum of two months prior to randomization. participants must agree to stay on stable doses of diabetes, antihypertensive and lipid medication for the duration of the study.
boolean
C0003364 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0020616 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0086440 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0935929 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Poorly controlled diabetes mellitus | Hemoglobin A1c measurement
Item
major exclusion criteria will be poorly controlled diabetes (hemoglobin a1c >9%)
boolean
C0554876 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Insulin use
Item
use of insulin
boolean
C0240016 (UMLS CUI [1])
Fish Oil Supplements | Fish Oil Supplements Discontinue Unwilling
Item
use of fish oil supplements or are unwilling to stop fish oil supplements one month prior to randomization and refrain from the supplements during the study
boolean
C0016157 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
C0016157 (UMLS CUI [2,1])
C0242295 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
Chronic kidney disease stage | Urine protein/creatinine ratio measurement
Item
stage 4 or stage 5 ckd or a screening urine protein/creatinine ratio of >2.5.
boolean
C2074731 (UMLS CUI [1])
C1096054 (UMLS CUI [2])
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