ID

33043

Beschrijving

The Effect of Nexium and Probiotics on Insulin Secretion and Cardiovascular Risk Factors in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00699426

Link

https://clinicaltrials.gov/show/NCT00699426

Trefwoorden

Versies (1)
  1. 24-11-18 24-11-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

24 november 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00699426

Engels

Eligibility Type 2 Diabetes NCT00699426

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes (who criteria) treated with metformin and/or sulfonylureas or diet
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Metformin | Sulfonylurea | Diet therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0038766
UMLS CUI [4]
C0012159
males and females between 40 and 70 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
hba1c between 6,0-10,0
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
diabetes duration > 1 year
Beschrijving

Diabetes Mellitus Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0449238
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
kidney disease (s-creatinine above the upper limit of normal range).
Beschrijving

Kidney Disease | Serum creatinine raised

Datatype

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0700225
liver disease (alat increase > 3 times the upper limit of the normal range of alat).
Beschrijving

Liver disease | Alanine aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151905
macroalbuminuria (urinary albumin excretion of > 300 mg/day).
Beschrijving

High urine albumin levels

Datatype

boolean

Alias
UMLS CUI [1]
C1654921
heart failure(nyha class lll or lv)
Beschrijving

Heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
severe neuropathy (symptoms + vibration perception threshold > 50 measured by biothesiometer.)
Beschrijving

Symptoms Neuropathy Severe | Determine vibration perception threshold Biothesiometer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0442874
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C1736033
UMLS CUI [2,2]
C0810485
neutropenia (neutrophil count<2.0x10/l) or anemia (hemoglobin<8mm for men or <7mm for women.
Beschrijving

Neutropenia | Neutrophil count | Anemia | Hemoglobin measurement | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0027947
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0002871
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0079399
alcohol abuse
Beschrijving

Alcohol abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0085762
drug abuse
Beschrijving

Drug abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0013146
severe organic or metabolic diseases including cancer
Beschrijving

Organic disease Severe | Metabolic Disease Severe | Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0683324
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0025517
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0006826
c-peptide< 0,3 pmol/l
Beschrijving

C-peptide measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202100
medicine interaction
Beschrijving

Drug Interactions

Datatype

boolean

Alias
UMLS CUI [1]
C0687133
treatment with insulin
Beschrijving

Insulin regime

Datatype

boolean

Alias
UMLS CUI [1]
C0557978
ppi or other medications for ulcus diseases
Beschrijving

Proton Pump Inhibitors Ulcer | Pharmaceutical Preparations Ulcer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0358591
UMLS CUI [1,2]
C0041582
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0041582
treatment with warfarin or other coumarin derivations
Beschrijving

Warfarin | Coumarins

Datatype

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0010207
pregnant or breastfeeding women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
allergy to medication used in the study
Beschrijving

Hypersensitivity Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
participants may not participate in another clinical intervention trial
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Type 2 Diabetes NCT00699426

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Metformin | Sulfonylurea | Diet therapy
Item
type 2 diabetes (who criteria) treated with metformin and/or sulfonylureas or diet
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C0038766 (UMLS CUI [3])
C0012159 (UMLS CUI [4])
Age
Item
males and females between 40 and 70 years
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c between 6,0-10,0
boolean
C0474680 (UMLS CUI [1])
Diabetes Mellitus Duration
Item
diabetes duration > 1 year
boolean
C0011849 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Kidney Disease | Serum creatinine raised
Item
kidney disease (s-creatinine above the upper limit of normal range).
boolean
C0022658 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Liver disease | Alanine aminotransferase increased
Item
liver disease (alat increase > 3 times the upper limit of the normal range of alat).
boolean
C0023895 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
High urine albumin levels
Item
macroalbuminuria (urinary albumin excretion of > 300 mg/day).
boolean
C1654921 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
heart failure(nyha class lll or lv)
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Symptoms Neuropathy Severe | Determine vibration perception threshold Biothesiometer
Item
severe neuropathy (symptoms + vibration perception threshold > 50 measured by biothesiometer.)
boolean
C1457887 (UMLS CUI [1,1])
C0442874 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C1736033 (UMLS CUI [2,1])
C0810485 (UMLS CUI [2,2])
Neutropenia | Neutrophil count | Anemia | Hemoglobin measurement | Gender
Item
neutropenia (neutrophil count<2.0x10/l) or anemia (hemoglobin<8mm for men or <7mm for women.
boolean
C0027947 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0002871 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
Alcohol abuse
Item
alcohol abuse
boolean
C0085762 (UMLS CUI [1])
Drug abuse
Item
drug abuse
boolean
C0013146 (UMLS CUI [1])
Organic disease Severe | Metabolic Disease Severe | Malignant Neoplasms
Item
severe organic or metabolic diseases including cancer
boolean
C0683324 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0025517 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3])
C-peptide measurement
Item
c-peptide< 0,3 pmol/l
boolean
C0202100 (UMLS CUI [1])
Drug Interactions
Item
medicine interaction
boolean
C0687133 (UMLS CUI [1])
Insulin regime
Item
treatment with insulin
boolean
C0557978 (UMLS CUI [1])
Proton Pump Inhibitors Ulcer | Pharmaceutical Preparations Ulcer
Item
ppi or other medications for ulcus diseases
boolean
C0358591 (UMLS CUI [1,1])
C0041582 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0041582 (UMLS CUI [2,2])
Warfarin | Coumarins
Item
treatment with warfarin or other coumarin derivations
boolean
C0043031 (UMLS CUI [1])
C0010207 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs
Item
allergy to medication used in the study
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Study Subject Participation Status
Item
participants may not participate in another clinical intervention trial
boolean
C2348568 (UMLS CUI [1])
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