ID

40450

Beskrivning

Nutritional Intervention of Type II Diabetes Mellitus by Vitamin D in Qatar; ODM derived from: https://clinicaltrials.gov/show/NCT02098980

Länk

https://clinicaltrials.gov/show/NCT02098980

Nyckelord

Versioner (1)
  1. 2020-04-22 2020-04-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 april 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Insulin Resistance NCT02098980

Engelsk

Eligibility Insulin Resistance NCT02098980

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or non-pregnant, non-lactating females, aged 18-75
Beskrivning

Gender | Pregnancy Absent | Breast Feeding Absent | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0001779
volunteered to participate by signing the consent form
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
bmi ˂ 40kg/ m2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
serum 25(oh) vitamin d3 (25(oh)d) concentration ˂75nmol/l
Beskrivning

Serum 25-Hydroxy vitamin D3 measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278060
fasting serum glucose <7.0 mmol/l
Beskrivning

Serum fasting glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0583334
homa insulin resistance index ≥1.3
Beskrivning

HOMA Insulin Resistance Index

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1829779
UMLS CUI [1,2]
C0021655
UMLS CUI [1,3]
C0918012
presence of any one or more of the following risk factors for type 2 diabetes:
Beskrivning

Risk factors Quantity Non-Insulin-Dependent Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0011860
high bmi (>23)
Beskrivning

Body mass index High

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1305855
UMLS CUI [1,2]
C0205250
high waist circumference according to idf ethnic specific values for non-
Beskrivning

Waist Circumference High | Gender

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0455829
UMLS CUI [1,2]
C0205250
UMLS CUI [2]
C0079399
caucasian (females >80cm; males >90cm)
Beskrivning

ID.10

Datatyp

boolean

family history of diabetes in first-degree relative (parent or sibling)
Beskrivning

Family history of diabetes mellitus First Degree Relative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1313937
UMLS CUI [1,2]
C1517194
previous history of gestational diabetes
Beskrivning

Gestational Diabetes

Datatyp

boolean

Alias
UMLS CUI [1]
C0085207
history of high blood glucose, high triglycerides and/or low hdl cholesterol
Beskrivning

Hyperglycemia | Hypertriglyceridemia | Low HDL cholesterol

Datatyp

boolean

Alias
UMLS CUI [1]
C0020456
UMLS CUI [2]
C0020557
UMLS CUI [3]
C0151691
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
fasting serum glucose ≥7.0mmol/l
Beskrivning

Serum fasting glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0583334
history of renal failure or liver disease
Beskrivning

Kidney Failure | Liver disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0023895
serum urea or creatinine >1.8 times upper limit of normal (uln)
Beskrivning

Serum urea increased | Serum creatinine raised

Datatyp

boolean

Alias
UMLS CUI [1]
C0857448
UMLS CUI [2]
C0700225
serum aspartate or alanine transaminase (ast,alt) >1.5 times uln
Beskrivning

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
current use of drug or drugs to treat diabetes or which influence glucose metabolism
Beskrivning

Pharmacotherapy Diabetes Mellitus | Pharmaceutical Preparations Influence Glucose metabolism

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0011849
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C0596620
medical or surgical event requiring hospitalization within 3 months of randomization
Beskrivning

Event Medical Hospitalization Required | Event Surgical Hospitalization Required

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0205476
UMLS CUI [1,3]
C1708385
UMLS CUI [2,1]
C0441471
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C1708385
presence of any condition affecting nutrient absorption
Beskrivning

Condition Affecting Nutrient absorption

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1961155
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Similar models

Eligibility Insulin Resistance NCT02098980

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Pregnancy Absent | Breast Feeding Absent | Age
Item
male or non-pregnant, non-lactating females, aged 18-75
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
Informed Consent
Item
volunteered to participate by signing the consent form
boolean
C0021430 (UMLS CUI [1])
Body mass index
Item
bmi ˂ 40kg/ m2
boolean
C1305855 (UMLS CUI [1])
Serum 25-Hydroxy vitamin D3 measurement
Item
serum 25(oh) vitamin d3 (25(oh)d) concentration ˂75nmol/l
boolean
C1278060 (UMLS CUI [1])
Serum fasting glucose measurement
Item
fasting serum glucose <7.0 mmol/l
boolean
C0583334 (UMLS CUI [1])
HOMA Insulin Resistance Index
Item
homa insulin resistance index ≥1.3
boolean
C1829779 (UMLS CUI [1,1])
C0021655 (UMLS CUI [1,2])
C0918012 (UMLS CUI [1,3])
Risk factors Quantity Non-Insulin-Dependent Diabetes Mellitus
Item
presence of any one or more of the following risk factors for type 2 diabetes:
boolean
C0035648 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0011860 (UMLS CUI [1,3])
Body mass index High
Item
high bmi (>23)
boolean
C1305855 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
Waist Circumference High | Gender
Item
high waist circumference according to idf ethnic specific values for non-
boolean
C0455829 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
ID.10
Item
caucasian (females >80cm; males >90cm)
boolean
Family history of diabetes mellitus First Degree Relative
Item
family history of diabetes in first-degree relative (parent or sibling)
boolean
C1313937 (UMLS CUI [1,1])
C1517194 (UMLS CUI [1,2])
Gestational Diabetes
Item
previous history of gestational diabetes
boolean
C0085207 (UMLS CUI [1])
Hyperglycemia | Hypertriglyceridemia | Low HDL cholesterol
Item
history of high blood glucose, high triglycerides and/or low hdl cholesterol
boolean
C0020456 (UMLS CUI [1])
C0020557 (UMLS CUI [2])
C0151691 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Serum fasting glucose measurement
Item
fasting serum glucose ≥7.0mmol/l
boolean
C0583334 (UMLS CUI [1])
Kidney Failure | Liver disease
Item
history of renal failure or liver disease
boolean
C0035078 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
Serum urea increased | Serum creatinine raised
Item
serum urea or creatinine >1.8 times upper limit of normal (uln)
boolean
C0857448 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
serum aspartate or alanine transaminase (ast,alt) >1.5 times uln
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Pharmacotherapy Diabetes Mellitus | Pharmaceutical Preparations Influence Glucose metabolism
Item
current use of drug or drugs to treat diabetes or which influence glucose metabolism
boolean
C0013216 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
Event Medical Hospitalization Required | Event Surgical Hospitalization Required
Item
medical or surgical event requiring hospitalization within 3 months of randomization
boolean
C0441471 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C1708385 (UMLS CUI [1,3])
C0441471 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C1708385 (UMLS CUI [2,3])
Condition Affecting Nutrient absorption
Item
presence of any condition affecting nutrient absorption
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1961155 (UMLS CUI [1,3])
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