ID

34777

Description

Nutritional Intervention With Moderately High-protein, Low-glycemic Load Products in Type-2 Diabetes Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01264523

Link

https://clinicaltrials.gov/show/NCT01264523

Keywords

  1. 1/28/19 1/28/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 28, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Type-2 Diabetes NCT01264523

Eligibility Type-2 Diabetes NCT01264523

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinically diagnosed of type-2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
under dietary treatment or with metformin
Description

Diet therapy | Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0025598
body mass index (bmi) between 22 and 35 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
bmi under 22 or over 35 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
to follow a pharmacological treatment with other drugs but metformin
Description

Pharmacotherapy | Exception Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0013216
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
to be already insulin-dependent
Description

Dependence on Insulin

Data type

boolean

Alias
UMLS CUI [1,1]
C0439857
UMLS CUI [1,2]
C0021641
to have other concomitant pharmacological treatments for weight loss, hormonal substitutive therapy, altered thyroid function, etc. without an stable dosage (at least three months prior the beginning of the study).
Description

Weight-Loss Agents | Hormone replacement therapy | Thyroid function altered

Data type

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2]
C0282402
UMLS CUI [3,1]
C2242456
UMLS CUI [3,2]
C0392747
to suffer from complications due to type 2 diabetes (microangiopathy, polyneuropathy, cardiopathy, hepatic and renal impairments, etc)
Description

Complications Due to Non-Insulin-Dependent Diabetes Mellitus | Microangiopathy | Polyneuropathy | Heart Disease | Hepatic impairment | Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0011860
UMLS CUI [2]
C0155765
UMLS CUI [3]
C0152025
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0948807
UMLS CUI [6]
C1565489
to have a recent (less than 3 months before the beginning of the study) uncontrolled diagnostic of hypercholesterolemia and/or hypertriglyceridemia.
Description

Hypercholesterolemia Uncontrolled | Hypertriglyceridemia Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0020443
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0020557
UMLS CUI [2,2]
C0205318

Similar models

Eligibility Type-2 Diabetes NCT01264523

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
clinically diagnosed of type-2 diabetes
boolean
C0011860 (UMLS CUI [1])
Diet therapy | Metformin
Item
under dietary treatment or with metformin
boolean
C0012159 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
Body mass index
Item
body mass index (bmi) between 22 and 35 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Body mass index
Item
bmi under 22 or over 35 kg/m2
boolean
C1305855 (UMLS CUI [1])
Pharmacotherapy | Exception Metformin
Item
to follow a pharmacological treatment with other drugs but metformin
boolean
C0013216 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Dependence on Insulin
Item
to be already insulin-dependent
boolean
C0439857 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
Weight-Loss Agents | Hormone replacement therapy | Thyroid function altered
Item
to have other concomitant pharmacological treatments for weight loss, hormonal substitutive therapy, altered thyroid function, etc. without an stable dosage (at least three months prior the beginning of the study).
boolean
C0376606 (UMLS CUI [1])
C0282402 (UMLS CUI [2])
C2242456 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
Complications Due to Non-Insulin-Dependent Diabetes Mellitus | Microangiopathy | Polyneuropathy | Heart Disease | Hepatic impairment | Renal Insufficiency
Item
to suffer from complications due to type 2 diabetes (microangiopathy, polyneuropathy, cardiopathy, hepatic and renal impairments, etc)
boolean
C0009566 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0011860 (UMLS CUI [1,3])
C0155765 (UMLS CUI [2])
C0152025 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0948807 (UMLS CUI [5])
C1565489 (UMLS CUI [6])
Hypercholesterolemia Uncontrolled | Hypertriglyceridemia Uncontrolled
Item
to have a recent (less than 3 months before the beginning of the study) uncontrolled diagnostic of hypercholesterolemia and/or hypertriglyceridemia.
boolean
C0020443 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0020557 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial