ID

38832

Description

Variation of Glucose Values at Early Stages of Diabetes - Continuous Glucose Monitoring; ODM derived from: https://clinicaltrials.gov/show/NCT02294370

Link

https://clinicaltrials.gov/show/NCT02294370

Keywords

Versions (1)
  1. 11/7/19 11/7/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 7, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02294370

English

Eligibility Diabetes Mellitus, Type 2 NCT02294370

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
individuals with impaired glucose tolerance (2h plasma glucose during oral glucose tolerance test >7.8-11.1 mmol/l, n=50) or with type 2 diabetes (fasting plasma glucose > 7.0 mmol/l and/or 2h plasma glucose > 11.1 mmol/l on two occasions, or both criteria fulfilled in the same oral glucose tolerance test while not pregnant, n=50) with short duration (<3 years); 40 from padova university hospital, 60 from the botnia study or the ppp (prevalence, prediction, prevention)-botnia study in finland.
Description

Decreased glucose tolerance | Plasma Glucose Measurement Oral Glucose Tolerance Test | Diabetes Mellitus, Non-Insulin-Dependent | Plasma fasting glucose measurement | Pregnancy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0151671
UMLS CUI [2,1]
C0202042
UMLS CUI [2,2]
C0029161
UMLS CUI [3]
C0011860
UMLS CUI [4]
C0583513
UMLS CUI [5,1]
C0032961
UMLS CUI [5,2]
C0332197
age 40-75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
medication with: insulin, glucagon-like peptide-1 (glp-1)-analogues, sulphonylureas, oral corticosteroids, thyreostatic agents or thyroid hormone, luteinizing-hormone-releasing hormone (lhrh) analogues
Description

Insulin | GLP-1 Analogue | Sulfonylurea | Adrenal Cortex Hormones Oral | Thyreostatic therapy | Thyroid Hormones | LH-RH Analogs

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C3273809
UMLS CUI [3]
C0038766
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C1527415
UMLS CUI [5]
C1696471
UMLS CUI [6]
C0040135
UMLS CUI [7]
C1518041
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
known changes in retinal fundus photographs
Description

Change Ophthalmoscopy Retinal

Data type

boolean

Alias
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C0029090
UMLS CUI [1,3]
C0035298
known, microalbuminuria
Description

Microalbuminuria

Data type

boolean

Alias
UMLS CUI [1]
C0730345
hba1c >8%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
fasting plasma glucose >10 mmol/l
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
medication with metformin, glitazones, gliptins (or acarbose) is allowed but gliptins and acarbose need to be stopped 2 days before testing and during the study
Description

Metformin allowed | Thiazolidinediones allowed | Gliptins To be stopped | Acarbose To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0683607
UMLS CUI [2,1]
C1257987
UMLS CUI [2,2]
C0683607
UMLS CUI [3,1]
C1827106
UMLS CUI [3,2]
C1272691
UMLS CUI [4,1]
C0050393
UMLS CUI [4,2]
C1272691
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02294370

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Decreased glucose tolerance | Plasma Glucose Measurement Oral Glucose Tolerance Test | Diabetes Mellitus, Non-Insulin-Dependent | Plasma fasting glucose measurement | Pregnancy Absent
Item
individuals with impaired glucose tolerance (2h plasma glucose during oral glucose tolerance test >7.8-11.1 mmol/l, n=50) or with type 2 diabetes (fasting plasma glucose > 7.0 mmol/l and/or 2h plasma glucose > 11.1 mmol/l on two occasions, or both criteria fulfilled in the same oral glucose tolerance test while not pregnant, n=50) with short duration (<3 years); 40 from padova university hospital, 60 from the botnia study or the ppp (prevalence, prediction, prevention)-botnia study in finland.
boolean
C0151671 (UMLS CUI [1])
C0202042 (UMLS CUI [2,1])
C0029161 (UMLS CUI [2,2])
C0011860 (UMLS CUI [3])
C0583513 (UMLS CUI [4])
C0032961 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Age
Item
age 40-75 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Insulin | GLP-1 Analogue | Sulfonylurea | Adrenal Cortex Hormones Oral | Thyreostatic therapy | Thyroid Hormones | LH-RH Analogs
Item
medication with: insulin, glucagon-like peptide-1 (glp-1)-analogues, sulphonylureas, oral corticosteroids, thyreostatic agents or thyroid hormone, luteinizing-hormone-releasing hormone (lhrh) analogues
boolean
C0021641 (UMLS CUI [1])
C3273809 (UMLS CUI [2])
C0038766 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C1696471 (UMLS CUI [5])
C0040135 (UMLS CUI [6])
C1518041 (UMLS CUI [7])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Change Ophthalmoscopy Retinal
Item
known changes in retinal fundus photographs
boolean
C0392747 (UMLS CUI [1,1])
C0029090 (UMLS CUI [1,2])
C0035298 (UMLS CUI [1,3])
Microalbuminuria
Item
known, microalbuminuria
boolean
C0730345 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c >8%
boolean
C0474680 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasting plasma glucose >10 mmol/l
boolean
C0583513 (UMLS CUI [1])
Metformin allowed | Thiazolidinediones allowed | Gliptins To be stopped | Acarbose To be stopped
Item
medication with metformin, glitazones, gliptins (or acarbose) is allowed but gliptins and acarbose need to be stopped 2 days before testing and during the study
boolean
C0025598 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C1257987 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C1827106 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
C0050393 (UMLS CUI [4,1])
C1272691 (UMLS CUI [4,2])
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