ID

17311

Beskrivning

Urinary Vitamin C Loss in Diabetic Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00071526

Länk

https://clinicaltrials.gov/show/NCT00071526

Nyckelord

Versioner (1)
  1. 2016-09-06 2016-09-06 -
Uppladdad den

6 september 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Type 1 NCT00071526

Engelsk

Eligibility Diabetes Type 1 NCT00071526

1 Formulär  
Criteria
Beskrivning

Criteria

we propose to study an unlimited number of male and female subjects between the ages of 18 and 65. this will include healthy subjects and subjects with type 1 or type 2 diabetes. to be included in the study, study subjects should
Beskrivning

Age | Healthy Volunteers | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1708335
UMLS CUI [3]
C0011854
UMLS CUI [4]
C0011860
be in good general health
Beskrivning

General health good

Datatyp

boolean

Alias
UMLS CUI [1]
C1277245
have no significant illnesses that compromise clinical stability other than the complications of diabetes mellitus alone or in the context of metabolic syndrome. subjects with ischemic heart disease and/or peripheral artery disease are eligible for arm 1 of the protocol.
Beskrivning

Illness Significant compromises Stable status Clinical | Complications of Diabetes Mellitus | Metabolic Syndrome | Myocardial Ischemia | Peripheral Arterial Diseases

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C0205360
UMLS CUI [1,5]
C0205210
UMLS CUI [2]
C0342257
UMLS CUI [3]
C0524620
UMLS CUI [4]
C0151744
UMLS CUI [5]
C1704436
have serum creatinine < 2.5
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
for healthy volunteers, be normotensive at the time of the study, with a blood pressure less than or equal to 140/90
Beskrivning

Healthy Volunteers normotensive | Blood Pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C2712122
UMLS CUI [2]
C0005823
for diabetic subjects, blood pressure less than or equal to 170/95 as long as clinically stable and in usual state of health, for example, no chest pain, shortness of breath, headache, syncope or fatigue
Beskrivning

Study Subject Diabetic | Blood Pressure | Stable status Clinical | health Usual | Chest Pain | Dyspnea | Headache | Syncope | Fatigue

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0241863
UMLS CUI [2]
C0005823
UMLS CUI [3,1]
C0205360
UMLS CUI [3,2]
C0205210
UMLS CUI [4,1]
C0683314
UMLS CUI [4,2]
C3538928
UMLS CUI [5]
C0008031
UMLS CUI [6]
C0013404
UMLS CUI [7]
C0018681
UMLS CUI [8]
C0039070
UMLS CUI [9]
C0015672
the aim of this study is to determine whether diabetic subjects lose vitamin c in the urine in their normal clinical condition (i.e. while on treatment) and not in the native untreated state of uncontrolled hyperglycemia. therefore the patients will not discontinue medication.
Beskrivning

Study Subject Diabetic | Condition Clinical Normal | Urine vitamin C measurement | Hyperglycemia Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0241863
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0205210
UMLS CUI [2,3]
C0205307
UMLS CUI [3]
C1278265
UMLS CUI [4,1]
C0020456
UMLS CUI [4,2]
C0205318
exclusion criteria (for arm 1):
Beskrivning

Exclusion Criteria Protocol Treatment Arm

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1522541
exclusion criteria will include the following:
Beskrivning

ID.9

Datatyp

boolean

significant organ malfunction leading to clinical instability including liver disease, pulmonary disease, stroke and anemia at investigator discretion
Beskrivning

Organ failure Significant Causing Instability Clinical | Liver diseases | Lung diseases | Cerebrovascular accident | Anemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231174
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0678227
UMLS CUI [1,4]
C1444783
UMLS CUI [1,5]
C0205210
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0002871
serious or chronic illness or history of serious or chronic illness resulting in clinical instability other than complications of diabetes
Beskrivning

Illness Serious Causing Instability Clinical | Chronic disease Causing Instability Clinical | Complications of Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0678227
UMLS CUI [1,4]
C1444783
UMLS CUI [1,5]
C0205210
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C1444783
UMLS CUI [2,4]
C0205210
UMLS CUI [3]
C0342257
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
alcohol abuse, drug addiction or the use of illegal drugs
Beskrivning

Alcohol abuse | Drug Dependence | Illicit drug use

Datatyp

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C1510472
UMLS CUI [3]
C0281875
positive hiv or hepatitis (b or c) screening tests (subjects will be notified of these test results).
Beskrivning

HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0856706
UMLS CUI [3]
C1112419
presence of other concomitant conditions which in the judgment of the investigators can influence vitamin c metabolism or vitamin c renal handling
Beskrivning

Comorbidity Affecting Vitamin C metabolism | Comorbidity Affecting Vitamin C Kidney Handling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1158854
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0003968
UMLS CUI [2,4]
C0022646
UMLS CUI [2,5]
C1832073
exclusion criteria (for arms 2 and 3):
Beskrivning

Exclusion Criteria Protocol Treatment Arm

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1522541
exclusion criteria will include the following:
Beskrivning

ID.17

Datatyp

boolean

significant organ malfunction leading to clinical instability including liver disease, pulmonary disease, ischemic heart disease, heart failure, stroke, peripheral vascular disease, and anemia at investigator discretion
Beskrivning

Organ failure Significant Causing Instability Clinical | Liver diseases | Lung diseases | Myocardial Ischemia | Heart failure | Cerebrovascular accident | Peripheral Vascular Diseases | Anemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231174
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0678227
UMLS CUI [1,4]
C1444783
UMLS CUI [1,5]
C0205210
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0151744
UMLS CUI [5]
C0018801
UMLS CUI [6]
C0038454
UMLS CUI [7]
C0085096
UMLS CUI [8]
C0002871
other serious or chronic illness; history of serious or chronic illness; coronary artery disease, or peripheral vascular disease resulting in clinical instability
Beskrivning

Illness Serious | Chronic disease | Coronary Artery Disease Causing Instability Clinical | Peripheral Vascular Diseases Causing Instability Clinical

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0008679
UMLS CUI [3,1]
C1956346
UMLS CUI [3,2]
C0678227
UMLS CUI [3,3]
C1444783
UMLS CUI [3,4]
C0205210
UMLS CUI [4,1]
C0085096
UMLS CUI [4,2]
C0678227
UMLS CUI [4,3]
C1444783
UMLS CUI [4,4]
C0205210
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
alcohol abuse, drug addiction or the use of illegal drugs
Beskrivning

Alcohol abuse | Drug Dependence | Illicit drug use

Datatyp

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C1510472
UMLS CUI [3]
C0281875
positive hiv or hepatitis (b or c) screening tests (subjects will be notified of these test results).
Beskrivning

HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0856706
UMLS CUI [3]
C1112419
presence of other concomitant conditions which in the judgment of the investigators can influence vitamin c metabolism or vitamin c renal handling
Beskrivning

Comorbidity Affecting Vitamin C metabolism | Comorbidity Affecting Vitamin C Kidney Handling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1158854
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0003968
UMLS CUI [2,4]
C0022646
UMLS CUI [2,5]
C1832073
for inpatient subjects, an additional exclusion criterion is consumption during the hospitalization of any foods or beverages other than those in the vitamin c free diet.
Beskrivning

Exclusion Criteria Inpatient | Food Consumption During Hospitalization | Drinking Beverages During Hospitalization | Diet Vitamin C Free of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0021562
UMLS CUI [2,1]
C2983605
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C0019993
UMLS CUI [3,1]
C0684271
UMLS CUI [3,2]
C0005329
UMLS CUI [3,3]
C0347984
UMLS CUI [3,4]
C0019993
UMLS CUI [4,1]
C0012155
UMLS CUI [4,2]
C0003968
UMLS CUI [4,3]
C0332296
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Similar models

Eligibility Diabetes Type 1 NCT00071526

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Age | Healthy Volunteers | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
we propose to study an unlimited number of male and female subjects between the ages of 18 and 65. this will include healthy subjects and subjects with type 1 or type 2 diabetes. to be included in the study, study subjects should
boolean
C0001779 (UMLS CUI [1])
C1708335 (UMLS CUI [2])
C0011854 (UMLS CUI [3])
C0011860 (UMLS CUI [4])
General health good
Item
be in good general health
boolean
C1277245 (UMLS CUI [1])
Illness Significant compromises Stable status Clinical | Complications of Diabetes Mellitus | Metabolic Syndrome | Myocardial Ischemia | Peripheral Arterial Diseases
Item
have no significant illnesses that compromise clinical stability other than the complications of diabetes mellitus alone or in the context of metabolic syndrome. subjects with ischemic heart disease and/or peripheral artery disease are eligible for arm 1 of the protocol.
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0205210 (UMLS CUI [1,5])
C0342257 (UMLS CUI [2])
C0524620 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
C1704436 (UMLS CUI [5])
Creatinine measurement, serum
Item
have serum creatinine < 2.5
boolean
C0201976 (UMLS CUI [1])
Healthy Volunteers normotensive | Blood Pressure
Item
for healthy volunteers, be normotensive at the time of the study, with a blood pressure less than or equal to 140/90
boolean
C1708335 (UMLS CUI [1,1])
C2712122 (UMLS CUI [1,2])
C0005823 (UMLS CUI [2])
Study Subject Diabetic | Blood Pressure | Stable status Clinical | health Usual | Chest Pain | Dyspnea | Headache | Syncope | Fatigue
Item
for diabetic subjects, blood pressure less than or equal to 170/95 as long as clinically stable and in usual state of health, for example, no chest pain, shortness of breath, headache, syncope or fatigue
boolean
C0681850 (UMLS CUI [1,1])
C0241863 (UMLS CUI [1,2])
C0005823 (UMLS CUI [2])
C0205360 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
C0683314 (UMLS CUI [4,1])
C3538928 (UMLS CUI [4,2])
C0008031 (UMLS CUI [5])
C0013404 (UMLS CUI [6])
C0018681 (UMLS CUI [7])
C0039070 (UMLS CUI [8])
C0015672 (UMLS CUI [9])
Study Subject Diabetic | Condition Clinical Normal | Urine vitamin C measurement | Hyperglycemia Uncontrolled
Item
the aim of this study is to determine whether diabetic subjects lose vitamin c in the urine in their normal clinical condition (i.e. while on treatment) and not in the native untreated state of uncontrolled hyperglycemia. therefore the patients will not discontinue medication.
boolean
C0681850 (UMLS CUI [1,1])
C0241863 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
C1278265 (UMLS CUI [3])
C0020456 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Exclusion Criteria Protocol Treatment Arm
Item
exclusion criteria (for arm 1):
boolean
C0680251 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
ID.9
Item
exclusion criteria will include the following:
boolean
Organ failure Significant Causing Instability Clinical | Liver diseases | Lung diseases | Cerebrovascular accident | Anemia
Item
significant organ malfunction leading to clinical instability including liver disease, pulmonary disease, stroke and anemia at investigator discretion
boolean
C0231174 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C1444783 (UMLS CUI [1,4])
C0205210 (UMLS CUI [1,5])
C0023895 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0002871 (UMLS CUI [5])
Illness Serious Causing Instability Clinical | Chronic disease Causing Instability Clinical | Complications of Diabetes Mellitus
Item
serious or chronic illness or history of serious or chronic illness resulting in clinical instability other than complications of diabetes
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C1444783 (UMLS CUI [1,4])
C0205210 (UMLS CUI [1,5])
C0008679 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C1444783 (UMLS CUI [2,3])
C0205210 (UMLS CUI [2,4])
C0342257 (UMLS CUI [3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Alcohol abuse | Drug Dependence | Illicit drug use
Item
alcohol abuse, drug addiction or the use of illegal drugs
boolean
C0085762 (UMLS CUI [1])
C1510472 (UMLS CUI [2])
C0281875 (UMLS CUI [3])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
positive hiv or hepatitis (b or c) screening tests (subjects will be notified of these test results).
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Comorbidity Affecting Vitamin C metabolism | Comorbidity Affecting Vitamin C Kidney Handling
Item
presence of other concomitant conditions which in the judgment of the investigators can influence vitamin c metabolism or vitamin c renal handling
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1158854 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0003968 (UMLS CUI [2,3])
C0022646 (UMLS CUI [2,4])
C1832073 (UMLS CUI [2,5])
Exclusion Criteria Protocol Treatment Arm
Item
exclusion criteria (for arms 2 and 3):
boolean
C0680251 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
ID.17
Item
exclusion criteria will include the following:
boolean
Organ failure Significant Causing Instability Clinical | Liver diseases | Lung diseases | Myocardial Ischemia | Heart failure | Cerebrovascular accident | Peripheral Vascular Diseases | Anemia
Item
significant organ malfunction leading to clinical instability including liver disease, pulmonary disease, ischemic heart disease, heart failure, stroke, peripheral vascular disease, and anemia at investigator discretion
boolean
C0231174 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C1444783 (UMLS CUI [1,4])
C0205210 (UMLS CUI [1,5])
C0023895 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
C0018801 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C0085096 (UMLS CUI [7])
C0002871 (UMLS CUI [8])
Illness Serious | Chronic disease | Coronary Artery Disease Causing Instability Clinical | Peripheral Vascular Diseases Causing Instability Clinical
Item
other serious or chronic illness; history of serious or chronic illness; coronary artery disease, or peripheral vascular disease resulting in clinical instability
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2])
C1956346 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C1444783 (UMLS CUI [3,3])
C0205210 (UMLS CUI [3,4])
C0085096 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C1444783 (UMLS CUI [4,3])
C0205210 (UMLS CUI [4,4])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Alcohol abuse | Drug Dependence | Illicit drug use
Item
alcohol abuse, drug addiction or the use of illegal drugs
boolean
C0085762 (UMLS CUI [1])
C1510472 (UMLS CUI [2])
C0281875 (UMLS CUI [3])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
positive hiv or hepatitis (b or c) screening tests (subjects will be notified of these test results).
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Comorbidity Affecting Vitamin C metabolism | Comorbidity Affecting Vitamin C Kidney Handling
Item
presence of other concomitant conditions which in the judgment of the investigators can influence vitamin c metabolism or vitamin c renal handling
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1158854 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0003968 (UMLS CUI [2,3])
C0022646 (UMLS CUI [2,4])
C1832073 (UMLS CUI [2,5])
Exclusion Criteria Inpatient | Food Consumption During Hospitalization | Drinking Beverages During Hospitalization | Diet Vitamin C Free of
Item
for inpatient subjects, an additional exclusion criterion is consumption during the hospitalization of any foods or beverages other than those in the vitamin c free diet.
boolean
C0680251 (UMLS CUI [1,1])
C0021562 (UMLS CUI [1,2])
C2983605 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0019993 (UMLS CUI [2,3])
C0684271 (UMLS CUI [3,1])
C0005329 (UMLS CUI [3,2])
C0347984 (UMLS CUI [3,3])
C0019993 (UMLS CUI [3,4])
C0012155 (UMLS CUI [4,1])
C0003968 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
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