ID

35820

Beskrivning

Famine From Feast: Linking Vitamin C, Red Blood Cell Fragility, and Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02107976

Länk

https://clinicaltrials.gov/show/NCT02107976

Nyckelord

Versioner (1)
  1. 2019-03-25 2019-03-25 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

25 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Type 2 NCT02107976

Engelsk

Eligibility Diabetes Type 2 NCT02107976

1 Formulär  
Criteria
Beskrivning

Criteria

male or female 18-60 years old, able to give informed consent.
Beskrivning

Age | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
diabetes type 2 hga1c 7-12 percent on insulin and/or oral hypoglycemic agents.
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Insulin | Hypoglycemic Agents Oral

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0474680
UMLS CUI [3]
C0021641
UMLS CUI [4,1]
C0020616
UMLS CUI [4,2]
C1527415
in general good health with no other significant illness.
Beskrivning

General health good | Illness Other Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0332197
mild concomitant disease such as mild hypothyroidism (tsh < 10) is acceptable.
Beskrivning

Comorbidity Mild Acceptable | Hypothyroidism Mild | Thyroid stimulating hormone measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2945599
UMLS CUI [1,3]
C1879533
UMLS CUI [2,1]
C0020676
UMLS CUI [2,2]
C2945599
UMLS CUI [3]
C0202230
blood pressure with or without medication < 160/90 mmhg with no known significant target organ damage (end organ damage includes the following: proliferative retinopathy, serum creatinine > 1.5 or egfr < 55 ml/min, symptomatic ischemic heart disease, severe congestive heart failure, advanced peripheral vascular disease.
Beskrivning

Blood pressure determination | Relationship Pharmaceutical Preparations | Independent of Pharmaceutical Preparations | Target Organ Damage Absent | Proliferative retinopathy | Creatinine measurement, serum | Estimated Glomerular Filtration Rate | Myocardial Ischemia Symptomatic | Congestive heart failure Severe | Peripheral Vascular Disease Advanced

Datatyp

boolean

Alias
UMLS CUI [1]
C0005824
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0013227
UMLS CUI [3,1]
C0332291
UMLS CUI [3,2]
C0013227
UMLS CUI [4,1]
C1521840
UMLS CUI [4,2]
C0178784
UMLS CUI [4,3]
C1883709
UMLS CUI [4,4]
C0332197
UMLS CUI [5]
C0339467
UMLS CUI [6]
C0201976
UMLS CUI [7]
C3811844
UMLS CUI [8,1]
C0151744
UMLS CUI [8,2]
C0231220
UMLS CUI [9,1]
C0018802
UMLS CUI [9,2]
C0205082
UMLS CUI [10,1]
C0085096
UMLS CUI [10,2]
C0205179
plasma/rbc vitamin c levels less than or equal to 30 microm.
Beskrivning

Plasma Vitamin C level | Erythrocytes Vitamin C level

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C0201898
UMLS CUI [2,1]
C0014792
UMLS CUI [2,2]
C0201898
willingness to use effective contraceptive methods such as barrier method for the duration of study (female subjects).
Beskrivning

Gender Contraceptive methods | Contraception, Barrier

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0004764
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
diabetic type 1 subjects will be excluded due to the possibility of ketosis and hemodynamic instability with lack of insulin.
Beskrivning

Diabetes Mellitus, Insulin-Dependent | At risk Ketosis | At risk Hemodynamic instability

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0022638
UMLS CUI [3,1]
C1444641
UMLS CUI [3,2]
C0948268
any subjective or objective evidence of microangiopathy such as history of claudication, symptomatic peripheral vascular disease, symptomatic coronary artery disease, stroke, retinopathy, nephropathy (serum creatinine > 1.5 or egfr < 55 ml/min).
Beskrivning

Microangiopathy | Claudication | Peripheral Vascular Diseases Symptomatic | Coronary Artery Disease Symptomatic | Cerebrovascular accident | Retinal Diseases | Kidney Diseases | Creatinine measurement, serum | Estimated Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C0155765
UMLS CUI [2]
C1456822
UMLS CUI [3,1]
C0085096
UMLS CUI [3,2]
C0231220
UMLS CUI [4,1]
C1956346
UMLS CUI [4,2]
C0231220
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0035309
UMLS CUI [7]
C0022658
UMLS CUI [8]
C0201976
UMLS CUI [9]
C3811844
subjects with retinopathy to avoid accelerated retinopathy with hyperglycemia.
Beskrivning

Retinal Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0035309
concomitant disease such as severe heart failure, severe liver disease (transaminases > 3 times normal), or severe systemic disease of any sort.
Beskrivning

Comorbidity | Heart failure Severe | Liver disease Severe | Transaminases increased | Systemic disease Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0438717
UMLS CUI [5,1]
C0442893
UMLS CUI [5,2]
C0205082
participation in each protocol delineated evaluation procedure will be judged on a case by case basis with patient safety as the paramount consideration.
Beskrivning

Study Subject Participation Status | Consideration Patient safety

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C1113679
pregnancy, breastfeeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of diabetic ketoacidosis or hyperosmolar coma.
Beskrivning

Diabetic Ketoacidosis | Hyperosmolar Coma

Datatyp

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C0020457
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Similar models

Eligibility Diabetes Type 2 NCT02107976

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Age | Informed Consent
Item
male or female 18-60 years old, able to give informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Insulin | Hypoglycemic Agents Oral
Item
diabetes type 2 hga1c 7-12 percent on insulin and/or oral hypoglycemic agents.
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0021641 (UMLS CUI [3])
C0020616 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
General health good | Illness Other Absent
Item
in general good health with no other significant illness.
boolean
C1277245 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Comorbidity Mild Acceptable | Hypothyroidism Mild | Thyroid stimulating hormone measurement
Item
mild concomitant disease such as mild hypothyroidism (tsh < 10) is acceptable.
boolean
C0009488 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
C0020676 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0202230 (UMLS CUI [3])
Blood pressure determination | Relationship Pharmaceutical Preparations | Independent of Pharmaceutical Preparations | Target Organ Damage Absent | Proliferative retinopathy | Creatinine measurement, serum | Estimated Glomerular Filtration Rate | Myocardial Ischemia Symptomatic | Congestive heart failure Severe | Peripheral Vascular Disease Advanced
Item
blood pressure with or without medication < 160/90 mmhg with no known significant target organ damage (end organ damage includes the following: proliferative retinopathy, serum creatinine > 1.5 or egfr < 55 ml/min, symptomatic ischemic heart disease, severe congestive heart failure, advanced peripheral vascular disease.
boolean
C0005824 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0332291 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C1521840 (UMLS CUI [4,1])
C0178784 (UMLS CUI [4,2])
C1883709 (UMLS CUI [4,3])
C0332197 (UMLS CUI [4,4])
C0339467 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C3811844 (UMLS CUI [7])
C0151744 (UMLS CUI [8,1])
C0231220 (UMLS CUI [8,2])
C0018802 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0085096 (UMLS CUI [10,1])
C0205179 (UMLS CUI [10,2])
Plasma Vitamin C level | Erythrocytes Vitamin C level
Item
plasma/rbc vitamin c levels less than or equal to 30 microm.
boolean
C0032105 (UMLS CUI [1,1])
C0201898 (UMLS CUI [1,2])
C0014792 (UMLS CUI [2,1])
C0201898 (UMLS CUI [2,2])
Gender Contraceptive methods | Contraception, Barrier
Item
willingness to use effective contraceptive methods such as barrier method for the duration of study (female subjects).
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0004764 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | At risk Ketosis | At risk Hemodynamic instability
Item
diabetic type 1 subjects will be excluded due to the possibility of ketosis and hemodynamic instability with lack of insulin.
boolean
C0011854 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0022638 (UMLS CUI [2,2])
C1444641 (UMLS CUI [3,1])
C0948268 (UMLS CUI [3,2])
Microangiopathy | Claudication | Peripheral Vascular Diseases Symptomatic | Coronary Artery Disease Symptomatic | Cerebrovascular accident | Retinal Diseases | Kidney Diseases | Creatinine measurement, serum | Estimated Glomerular Filtration Rate
Item
any subjective or objective evidence of microangiopathy such as history of claudication, symptomatic peripheral vascular disease, symptomatic coronary artery disease, stroke, retinopathy, nephropathy (serum creatinine > 1.5 or egfr < 55 ml/min).
boolean
C0155765 (UMLS CUI [1])
C1456822 (UMLS CUI [2])
C0085096 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C1956346 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0038454 (UMLS CUI [5])
C0035309 (UMLS CUI [6])
C0022658 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
C3811844 (UMLS CUI [9])
Retinal Disease
Item
subjects with retinopathy to avoid accelerated retinopathy with hyperglycemia.
boolean
C0035309 (UMLS CUI [1])
Comorbidity | Heart failure Severe | Liver disease Severe | Transaminases increased | Systemic disease Severe
Item
concomitant disease such as severe heart failure, severe liver disease (transaminases > 3 times normal), or severe systemic disease of any sort.
boolean
C0009488 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0438717 (UMLS CUI [4])
C0442893 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Study Subject Participation Status | Consideration Patient safety
Item
participation in each protocol delineated evaluation procedure will be judged on a case by case basis with patient safety as the paramount consideration.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C1113679 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnancy, breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Diabetic Ketoacidosis | Hyperosmolar Coma
Item
history of diabetic ketoacidosis or hyperosmolar coma.
boolean
C0011880 (UMLS CUI [1])
C0020457 (UMLS CUI [2])
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