ID

33157

Description

Effects of N-3 Polyunsaturated Fatty Acids On Chylomicron Secretion And Expression Of Genes That Regulate Intestinal Lipid Metabolism In Men With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01449773

Link

https://clinicaltrials.gov/show/NCT01449773

Keywords

Versions (1)
  1. 11/29/18 11/29/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 29, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT01449773

English

Eligibility Type 2 Diabetes NCT01449773

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age between 18 and 55 years,
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
plasma tg levels above the 50th percentile for age,
Description

Plasma triglyceride measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583329
non-smoker,
Description

Non-smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337672
bmi between 25.0 and 40.0 kg/m2,
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
stable body weight for at least 6 months prior to the study baseline,
Description

Stable body weight

Data type

boolean

Alias
UMLS CUI [1]
C0517386
hba1c between 6.5 and 8.5%,
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
baseline fasting plasma glucose < 15.0 mmol/l
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
patients with de novo type 2 diabetes not taking oral hypoglycemic agents -- - or patients having received stable doses of metformin for at least 3 months before randomization.
Description

Non-Insulin-Dependent Diabetes Mellitus de novo | Oral hypoglycemic Absent | Metformin Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C1515568
UMLS CUI [2,1]
C0359086
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
extreme dyslipidemias such as familial hypercholesterolemia,
Description

Dyslipidemias Extreme | Hypercholesterolemia, Familial

Data type

boolean

Alias
UMLS CUI [1,1]
C0242339
UMLS CUI [1,2]
C0205403
UMLS CUI [2]
C0020445
patients with secondary form of diabetes or acute metabolic diabetic complications,
Description

Secondary diabetes mellitus | Complications of Diabetes Mellitus Metabolic

Data type

boolean

Alias
UMLS CUI [1]
C0271640
UMLS CUI [2,1]
C0342257
UMLS CUI [2,2]
C0311400
patients having received or being treated with insulin or a thiazolidinedione within the past 6 months,
Description

Insulin | Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C1257987
subjects having cvd (chd, cerebrovascular disease or peripheral arterial disease)
Description

Cardiovascular Disease | Coronary heart disease | Cerebrovascular Disorder | Peripheral Arterial Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0010068
UMLS CUI [3]
C0007820
UMLS CUI [4]
C1704436
subjects taking medications known to affect lipoprotein metabolism (e.g. steroids, beta blockers, thiazide diuretics, lipid lowering agents,
Description

Pharmaceutical Preparations Affecting Lipoprotein metabolism | Steroids | Adrenergic beta-1 Receptor Antagonists | Thiazide Diuretics | Hypolipidemic Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1158917
UMLS CUI [2]
C0038317
UMLS CUI [3]
C0304516
UMLS CUI [4]
C0012802
UMLS CUI [5]
C0086440
significant alcohol intake
Description

Alcohol consumption Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0750502
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Similar models

Eligibility Type 2 Diabetes NCT01449773

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age between 18 and 55 years,
boolean
C0001779 (UMLS CUI [1])
Plasma triglyceride measurement
Item
plasma tg levels above the 50th percentile for age,
boolean
C0583329 (UMLS CUI [1])
Non-smoker
Item
non-smoker,
boolean
C0337672 (UMLS CUI [1])
Body mass index
Item
bmi between 25.0 and 40.0 kg/m2,
boolean
C1305855 (UMLS CUI [1])
Stable body weight
Item
stable body weight for at least 6 months prior to the study baseline,
boolean
C0517386 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c between 6.5 and 8.5%,
boolean
C0474680 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
baseline fasting plasma glucose < 15.0 mmol/l
boolean
C0583513 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus de novo | Oral hypoglycemic Absent | Metformin Dose Stable
Item
patients with de novo type 2 diabetes not taking oral hypoglycemic agents -- - or patients having received stable doses of metformin for at least 3 months before randomization.
boolean
C0011860 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0359086 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Dyslipidemias Extreme | Hypercholesterolemia, Familial
Item
extreme dyslipidemias such as familial hypercholesterolemia,
boolean
C0242339 (UMLS CUI [1,1])
C0205403 (UMLS CUI [1,2])
C0020445 (UMLS CUI [2])
Secondary diabetes mellitus | Complications of Diabetes Mellitus Metabolic
Item
patients with secondary form of diabetes or acute metabolic diabetic complications,
boolean
C0271640 (UMLS CUI [1])
C0342257 (UMLS CUI [2,1])
C0311400 (UMLS CUI [2,2])
Insulin | Thiazolidinediones
Item
patients having received or being treated with insulin or a thiazolidinedione within the past 6 months,
boolean
C0021641 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
Cardiovascular Disease | Coronary heart disease | Cerebrovascular Disorder | Peripheral Arterial Disease
Item
subjects having cvd (chd, cerebrovascular disease or peripheral arterial disease)
boolean
C0007222 (UMLS CUI [1])
C0010068 (UMLS CUI [2])
C0007820 (UMLS CUI [3])
C1704436 (UMLS CUI [4])
Pharmaceutical Preparations Affecting Lipoprotein metabolism | Steroids | Adrenergic beta-1 Receptor Antagonists | Thiazide Diuretics | Hypolipidemic Agents
Item
subjects taking medications known to affect lipoprotein metabolism (e.g. steroids, beta blockers, thiazide diuretics, lipid lowering agents,
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1158917 (UMLS CUI [1,3])
C0038317 (UMLS CUI [2])
C0304516 (UMLS CUI [3])
C0012802 (UMLS CUI [4])
C0086440 (UMLS CUI [5])
Alcohol consumption Significant
Item
significant alcohol intake
boolean
C0001948 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
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