ID

15171

Description

The Effect of Whey Protein Consumed as a Pre-meal on Postprandial Lipemia in Healthy and Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02343471

Link

https://clinicaltrials.gov/show/NCT02343471

Keywords

Versions (1)
  1. 5/20/16 5/20/16 -
Uploaded on

May 20, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Healthy NCT02343471

English

Eligibility Healthy NCT02343471

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Healthy NCT02343471
Criteria
Description

Criteria

weight stable for the last three month.
Description

Stable body weight

Data type

boolean

Alias
UMLS CUI [1]
C0517386
bmi<40
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
inclusion criteria for subjects with type 2 diabetes:
Description

Non-Insulin-Dependent Diabetes Mellitus Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C1512693
diagnosed type 2 diabetes (hba1c > 48 mmol/l)
Description

Diabetes Mellitus, Non-Insulin-Dependent | Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0019018
stable dose of metformin, sulfonylurea (su), insulin and sglt inhibitors are accepted.
Description

Metformin Dosage Stable | Sulfonylurea | Insulin | Sodium-Glucose Transporter Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C3536898
UMLS CUI [3]
C0021641
UMLS CUI [4]
C3665045
exclusion criteria - general:
Description

Exclusion Criteria General

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205246
type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
type 2 diabetes (hba1c ≥ 48 mmol/l)
Description

Diabetes Mellitus, Non-Insulin-Dependent | Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0019018
fasting plasma triglycerides > 5.0 mmol/l
Description

Plasma fasting triglyceride measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583331
blood pressure > 160/100 mmhg
Description

Blood Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0005823
cardiovascular, liver, kidney or metabolic disease
Description

Cardiovascular Diseases | Liver diseases | Kidney Diseases | Metabolic Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0025517
corticosteroid treatment
Description

Steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0149783
pregnancy or lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
alcohol or drug abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
legal incapacity
Description

Mental Incompetency Legal

Data type

boolean

Alias
UMLS CUI [1,1]
C0086455
UMLS CUI [1,2]
C1301860
exclusion criteria for subjects with type 2 diabetes:
Description

Non-Insulin-Dependent Diabetes Mellitus Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0680251
treatment with dpp-4 inhibitors, glp-1 agonists and basal bolus insulin.
Description

Therapeutic procedure Dipeptidyl Peptidase 4 Inhibitors | Therapeutic procedure Glucagon-like Peptide-1 (GLP-1) Agonists | Therapeutic procedure Basal insulin Bolus infusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2917254
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2916791
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0650607
UMLS CUI [3,3]
C1511237
fasting blood glucose ≥ 14 mmol/l.
Description

Fasting blood glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428568
exclusion criteria for healthy subjects:
Description

Healthy Subjects Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0680251
prediabetes, defined from the who criteria (igf ≥ 6.1 mmol/l).
Description

Prediabetes | WHO criteria | IGF

Data type

boolean

Alias
UMLS CUI [1]
C0362046
UMLS CUI [2,1]
C0043237
UMLS CUI [2,2]
C0679228
UMLS CUI [3]
C0037657
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Similar models

Eligibility Healthy NCT02343471

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Healthy NCT02343471
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Stable body weight
Item
weight stable for the last three month.
boolean
C0517386 (UMLS CUI [1])
Body mass index
Item
bmi<40
boolean
C1305855 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Inclusion criteria
Item
inclusion criteria for subjects with type 2 diabetes:
boolean
C0011860 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent | Glycosylated hemoglobin A
Item
diagnosed type 2 diabetes (hba1c > 48 mmol/l)
boolean
C0011860 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
Metformin Dosage Stable | Sulfonylurea | Insulin | Sodium-Glucose Transporter Inhibitors
Item
stable dose of metformin, sulfonylurea (su), insulin and sglt inhibitors are accepted.
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C3536898 (UMLS CUI [2])
C0021641 (UMLS CUI [3])
C3665045 (UMLS CUI [4])
Exclusion Criteria General
Item
exclusion criteria - general:
boolean
C0680251 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Glycosylated hemoglobin A
Item
type 2 diabetes (hba1c ≥ 48 mmol/l)
boolean
C0011860 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
Plasma fasting triglyceride measurement
Item
fasting plasma triglycerides > 5.0 mmol/l
boolean
C0583331 (UMLS CUI [1])
Blood Pressure
Item
blood pressure > 160/100 mmhg
boolean
C0005823 (UMLS CUI [1])
Cardiovascular Diseases | Liver diseases | Kidney Diseases | Metabolic Diseases
Item
cardiovascular, liver, kidney or metabolic disease
boolean
C0007222 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0025517 (UMLS CUI [4])
Steroid therapy
Item
corticosteroid treatment
boolean
C0149783 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Substance Use Disorders
Item
alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Mental Incompetency Legal
Item
legal incapacity
boolean
C0086455 (UMLS CUI [1,1])
C1301860 (UMLS CUI [1,2])
Non-Insulin-Dependent Diabetes Mellitus Exclusion Criteria
Item
exclusion criteria for subjects with type 2 diabetes:
boolean
C0011860 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Therapeutic procedure Dipeptidyl Peptidase 4 Inhibitors | Therapeutic procedure Glucagon-like Peptide-1 (GLP-1) Agonists | Therapeutic procedure Basal insulin Bolus infusion
Item
treatment with dpp-4 inhibitors, glp-1 agonists and basal bolus insulin.
boolean
C0087111 (UMLS CUI [1,1])
C2917254 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C2916791 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0650607 (UMLS CUI [3,2])
C1511237 (UMLS CUI [3,3])
Fasting blood glucose measurement
Item
fasting blood glucose ≥ 14 mmol/l.
boolean
C0428568 (UMLS CUI [1])
Healthy Subjects Exclusion Criteria
Item
exclusion criteria for healthy subjects:
boolean
C1708335 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Prediabetes | WHO criteria | IGF
Item
prediabetes, defined from the who criteria (igf ≥ 6.1 mmol/l).
boolean
C0362046 (UMLS CUI [1])
C0043237 (UMLS CUI [2,1])
C0679228 (UMLS CUI [2,2])
C0037657 (UMLS CUI [3])
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