ID

44270

Description

Dietary Protein and Insulin Sensitivity Study; ODM derived from: https://clinicaltrials.gov/show/NCT00508937

Link

https://clinicaltrials.gov/show/NCT00508937

Keywords

  1. 5/8/18 5/8/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Insulin Resistance NCT00508937

Eligibility Insulin Resistance NCT00508937

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
body mass index (bmi) ≥ 27 and ≤ 40 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
homa-ir ≥ 2.5
Description

Homeostasis model assessment Insulin Resistance

Data type

boolean

Alias
UMLS CUI [1,1]
C1829779
UMLS CUI [1,2]
C0021655
non-smoking
Description

Non-smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337672
total cholesterol and ldl cholesterol <95th percentile for sex and age
Description

Serum total cholesterol measurement | Serum LDL cholesterol measurement | Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C1445957
UMLS CUI [2]
C0428474
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0001779
fasting triglycerides < 500mg/dl
Description

Serum fasting triglyceride measurement

Data type

boolean

Alias
UMLS CUI [1]
C0582824
fasting blood sugar < 126
Description

Fasting Blood Sugar Measurement

Data type

boolean

Alias
UMLS CUI [1]
C2825162
urinary microalbumin < 30 mg/l
Description

Urinary Microalbumin Assay

Data type

boolean

Alias
UMLS CUI [1]
C2981750
normal thyroid stimulating hormone levels
Description

Serum TSH level normal

Data type

boolean

Alias
UMLS CUI [1]
C0580433
hematocrit ≥ 36%
Description

Hematocrit procedure

Data type

boolean

Alias
UMLS CUI [1]
C0018935
blood pressure < 150/90
Description

Blood pressure measurement

Data type

boolean

Alias
UMLS CUI [1]
C0005824
at least 3 months of a weight-stable state (± 5 lbs) prior to the study. during the study, subjects will be required to maintain their body weight within ± 3% (up to a maximum change of 5 lbs) of their initial weight over the course of any consecutive two weeks after the second week of baseline diet or during the last week of each diet phase
Description

Stable body weight | Requirement Body Weight Maintenance | Diet

Data type

boolean

Alias
UMLS CUI [1]
C0517386
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C4042910
UMLS CUI [3]
C0012155
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, hiv, or cancer (other than skin cancer) in the last 5 years
Description

Coronary heart disease | Cerebrovascular Disorder | Peripheral Vascular Disease | Blood Coagulation Disorders | Liver disease | Kidney Disease | Diabetes Mellitus | Lung disease | HIV Infection | Malignant Neoplasms | Exception Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2]
C0007820
UMLS CUI [3]
C0085096
UMLS CUI [4]
C0005779
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0011849
UMLS CUI [8]
C0024115
UMLS CUI [9]
C0019693
UMLS CUI [10]
C0006826
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0699893
use of drugs known to affect lipid metabolism or insulin resistance, hormones, or the blood thinning agent, warfarin
Description

Pharmaceutical Preparations Affecting Lipid Metabolism | Pharmaceutical Preparations Affecting Insulin Resistance | Hormone preparation | Anticoagulants | Warfarin

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0598783
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0021655
UMLS CUI [3]
C0019932
UMLS CUI [4]
C0003280
UMLS CUI [5]
C0043031
use of alcohol or dietary supplements during the study
Description

Alcohol consumption | Dietary Supplements

Data type

boolean

Alias
UMLS CUI [1]
C0001948
UMLS CUI [2]
C0242295
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Insulin Resistance NCT00508937

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
body mass index (bmi) ≥ 27 and ≤ 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Homeostasis model assessment Insulin Resistance
Item
homa-ir ≥ 2.5
boolean
C1829779 (UMLS CUI [1,1])
C0021655 (UMLS CUI [1,2])
Non-smoker
Item
non-smoking
boolean
C0337672 (UMLS CUI [1])
Serum total cholesterol measurement | Serum LDL cholesterol measurement | Gender | Age
Item
total cholesterol and ldl cholesterol <95th percentile for sex and age
boolean
C1445957 (UMLS CUI [1])
C0428474 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
Serum fasting triglyceride measurement
Item
fasting triglycerides < 500mg/dl
boolean
C0582824 (UMLS CUI [1])
Fasting Blood Sugar Measurement
Item
fasting blood sugar < 126
boolean
C2825162 (UMLS CUI [1])
Urinary Microalbumin Assay
Item
urinary microalbumin < 30 mg/l
boolean
C2981750 (UMLS CUI [1])
Serum TSH level normal
Item
normal thyroid stimulating hormone levels
boolean
C0580433 (UMLS CUI [1])
Hematocrit procedure
Item
hematocrit ≥ 36%
boolean
C0018935 (UMLS CUI [1])
Blood pressure measurement
Item
blood pressure < 150/90
boolean
C0005824 (UMLS CUI [1])
Stable body weight | Requirement Body Weight Maintenance | Diet
Item
at least 3 months of a weight-stable state (± 5 lbs) prior to the study. during the study, subjects will be required to maintain their body weight within ± 3% (up to a maximum change of 5 lbs) of their initial weight over the course of any consecutive two weeks after the second week of baseline diet or during the last week of each diet phase
boolean
C0517386 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C4042910 (UMLS CUI [2,2])
C0012155 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Coronary heart disease | Cerebrovascular Disorder | Peripheral Vascular Disease | Blood Coagulation Disorders | Liver disease | Kidney Disease | Diabetes Mellitus | Lung disease | HIV Infection | Malignant Neoplasms | Exception Skin carcinoma
Item
history of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, hiv, or cancer (other than skin cancer) in the last 5 years
boolean
C0010068 (UMLS CUI [1])
C0007820 (UMLS CUI [2])
C0085096 (UMLS CUI [3])
C0005779 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0011849 (UMLS CUI [7])
C0024115 (UMLS CUI [8])
C0019693 (UMLS CUI [9])
C0006826 (UMLS CUI [10])
C1705847 (UMLS CUI [11,1])
C0699893 (UMLS CUI [11,2])
Pharmaceutical Preparations Affecting Lipid Metabolism | Pharmaceutical Preparations Affecting Insulin Resistance | Hormone preparation | Anticoagulants | Warfarin
Item
use of drugs known to affect lipid metabolism or insulin resistance, hormones, or the blood thinning agent, warfarin
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0598783 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0021655 (UMLS CUI [2,3])
C0019932 (UMLS CUI [3])
C0003280 (UMLS CUI [4])
C0043031 (UMLS CUI [5])
Alcohol consumption | Dietary Supplements
Item
use of alcohol or dietary supplements during the study
boolean
C0001948 (UMLS CUI [1])
C0242295 (UMLS CUI [2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])

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