ID

38738

Description

Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2; ODM derived from: https://clinicaltrials.gov/show/NCT01497132

Link

https://clinicaltrials.gov/show/NCT01497132

Keywords

Versions (1)
  1. 10/31/19 10/31/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 31, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01497132

English

Eligibility Diabetes Mellitus, Type 2 NCT01497132

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
meeting criteria for ifg, igt, ifg+igt or diabetes mellitus at ogtt.
Description

Criteria Fulfill | Impaired fasting glycaemia | Impaired glucose tolerance | Diabetes Mellitus | Oral Glucose Tolerance Test

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
UMLS CUI [2]
C1272092
UMLS CUI [3]
C0271650
UMLS CUI [4]
C0011849
UMLS CUI [5]
C0029161
bmi ≤ 32 kg/m2.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hba1c ≤ 7.0 % (monos) or ≤ 63 mmol/mol (ifcc).
Description

Hemoglobin A1c measurement | Hemoglobin A1c measurement IFCC

Data type

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0474680
UMLS CUI [2,2]
C2964654
fasting plasma glucose < 9 mmol/l
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
s-25-oh-vitamin d3 < 75 nmol/l.
Description

Vitamin D3 measurement

Data type

boolean

Alias
UMLS CUI [1]
C0523979
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with any vitamin d preparation.
Description

Vitamin D-class Agent

Data type

boolean

Alias
UMLS CUI [1]
C2936842
regular sun-bathing in solarium.
Description

Sunbathing Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C0038813
UMLS CUI [1,2]
C0205272
hypercalcemia at screening, defined as free s-calcium > 1.35 mmol/l.
Description

Hypercalcemia | Serum calcium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0020437
UMLS CUI [2]
C0728876
hyperphosphatemia at screening, defined as s-phosphate > 1.5 mmol/l.
Description

Hyperphosphatemia | Serum Phosphate Measurement

Data type

boolean

Alias
UMLS CUI [1]
C0085681
UMLS CUI [2]
C1883013
sarcoidosis or other granulomatous disease.
Description

Sarcoidosis | Granulomatous disorder

Data type

boolean

Alias
UMLS CUI [1]
C0036202
UMLS CUI [2]
C0740451
treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin.
Description

Phenytoin | Barbiturates | Rifampin | isoniazid | Cardiac Glycosides | orlistat | Cholestyramine

Data type

boolean

Alias
UMLS CUI [1]
C0031507
UMLS CUI [2]
C0004745
UMLS CUI [3]
C0035608
UMLS CUI [4]
C0022209
UMLS CUI [5]
C0007158
UMLS CUI [6]
C0076275
UMLS CUI [7]
C0008402
impaired hepatic function.
Description

Liver Dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0086565
impaired renal function
Description

Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1565489
cardiac disease defined as:
Description

Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
unstable angina pectoris
Description

Angina, Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0002965
myocardial infarction within the last 6 months
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
congestive heart failure nyha class iii and iv
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
cerebral stroke within the last 6 months.
Description

Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0038454
anti-diabetic medication of any kind.
Description

Antidiabetics Kind Any

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
Description

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01497132

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill | Impaired fasting glycaemia | Impaired glucose tolerance | Diabetes Mellitus | Oral Glucose Tolerance Test
Item
meeting criteria for ifg, igt, ifg+igt or diabetes mellitus at ogtt.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1272092 (UMLS CUI [2])
C0271650 (UMLS CUI [3])
C0011849 (UMLS CUI [4])
C0029161 (UMLS CUI [5])
Body mass index
Item
bmi ≤ 32 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement | Hemoglobin A1c measurement IFCC
Item
hba1c ≤ 7.0 % (monos) or ≤ 63 mmol/mol (ifcc).
boolean
C0474680 (UMLS CUI [1])
C0474680 (UMLS CUI [2,1])
C2964654 (UMLS CUI [2,2])
Plasma fasting glucose measurement
Item
fasting plasma glucose < 9 mmol/l
boolean
C0583513 (UMLS CUI [1])
Vitamin D3 measurement
Item
s-25-oh-vitamin d3 < 75 nmol/l.
boolean
C0523979 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Vitamin D-class Agent
Item
treatment with any vitamin d preparation.
boolean
C2936842 (UMLS CUI [1])
Sunbathing Regular
Item
regular sun-bathing in solarium.
boolean
C0038813 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Hypercalcemia | Serum calcium measurement
Item
hypercalcemia at screening, defined as free s-calcium > 1.35 mmol/l.
boolean
C0020437 (UMLS CUI [1])
C0728876 (UMLS CUI [2])
Hyperphosphatemia | Serum Phosphate Measurement
Item
hyperphosphatemia at screening, defined as s-phosphate > 1.5 mmol/l.
boolean
C0085681 (UMLS CUI [1])
C1883013 (UMLS CUI [2])
Sarcoidosis | Granulomatous disorder
Item
sarcoidosis or other granulomatous disease.
boolean
C0036202 (UMLS CUI [1])
C0740451 (UMLS CUI [2])
Phenytoin | Barbiturates | Rifampin | isoniazid | Cardiac Glycosides | orlistat | Cholestyramine
Item
treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin.
boolean
C0031507 (UMLS CUI [1])
C0004745 (UMLS CUI [2])
C0035608 (UMLS CUI [3])
C0022209 (UMLS CUI [4])
C0007158 (UMLS CUI [5])
C0076275 (UMLS CUI [6])
C0008402 (UMLS CUI [7])
Liver Dysfunction
Item
impaired hepatic function.
boolean
C0086565 (UMLS CUI [1])
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
Heart Disease
Item
cardiac disease defined as:
boolean
C0018799 (UMLS CUI [1])
Angina, Unstable
Item
unstable angina pectoris
boolean
C0002965 (UMLS CUI [1])
Myocardial Infarction
Item
myocardial infarction within the last 6 months
boolean
C0027051 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
congestive heart failure nyha class iii and iv
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cerebrovascular accident
Item
cerebral stroke within the last 6 months.
boolean
C0038454 (UMLS CUI [1])
Antidiabetics Kind Any
Item
anti-diabetic medication of any kind.
boolean
C0935929 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent
Item
females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
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