ID

33125

Beschrijving

Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00993824

Link

https://clinicaltrials.gov/show/NCT00993824

Trefwoorden

Versies (1)
  1. 28-11-18 28-11-18 -
Houder van rechten

See clinicaltrials.gov

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28 november 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00993824

Engels

Eligibility Type 2 Diabetes NCT00993824

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female subjects ≥18 and ≤75 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
clinical diagnosis of type 2 diabetes
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
currently treated with metformin, a sulfonylurea, or combination metformin/sulfonylurea; stable dose for ≥3 months
Beschrijving

Metformin Dose Stable | Sulfonylurea Dose Stable | Combined Modality Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0038766
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0009429
hba1c of 7.0-9.0% inclusive
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
if taking lipid lowering medications, stable dose for >30 days
Beschrijving

Hypolipidemic Agents Dose Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086440
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
taken oral or injected prednisone or cortisone medications in the previous 30 days. (topical or inhaled steroids will not be considered excluded medications.)
Beschrijving

Prednisone Oral Product | Prednisone Injection | Cortisone Oral Product | Cortisone Injection | Topical steroids allowed | Inhaled steroids allowed

Datatype

boolean

Alias
UMLS CUI [1]
C3216040
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C1828121
UMLS CUI [3]
C3209977
UMLS CUI [4,1]
C0010137
UMLS CUI [4,2]
C1828121
UMLS CUI [5,1]
C2064827
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C2065041
UMLS CUI [6,2]
C0683607
current use of insulin or tzd's, or incretins
Beschrijving

Insulin | Thiazolidinediones | Incretins

Datatype

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C1257987
UMLS CUI [3]
C1562292
ldl <70 mg/dl
Beschrijving

Low density lipoprotein measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202116
serum triglycerides >500 mg/dl
Beschrijving

Serum Triglyceride Measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0542495
history of hypertriglyceridemia-induced pancreatitis
Beschrijving

Pancreatitis Hypertriglyceridemia Induced

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030305
UMLS CUI [1,2]
C0020557
UMLS CUI [1,3]
C0205263
history of gastrointestinal disorder such as dysphagia, swallowing disorder, intestinal motility disorder or prior bowel obstruction
Beschrijving

Gastrointestinal Disease | Deglutition Disorders | Deranged intestinal motility | Intestinal Obstruction

Datatype

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0011168
UMLS CUI [3]
C0232673
UMLS CUI [4]
C0021843
history or presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the investigator would compromise the subject's safety or successful participation in the study
Beschrijving

Medical condition Severe compromises Patient safety | Severe Mental Disorder compromises Patient safety | Chronic condition compromises Patient safety | Chronic infectious disease compromises Patient safety | Medical condition Severe compromises Study Subject Participation Status | Severe Mental Disorder compromises Study Subject Participation Status | Chronic condition compromises Study Subject Participation Status | Chronic infectious disease compromises Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C4046029
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C4315615
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C0151317
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C1113679
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0205082
UMLS CUI [5,3]
C2945640
UMLS CUI [5,4]
C2348568
UMLS CUI [6,1]
C4046029
UMLS CUI [6,2]
C2945640
UMLS CUI [6,3]
C2348568
UMLS CUI [7,1]
C4315615
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C2348568
UMLS CUI [8,1]
C0151317
UMLS CUI [8,2]
C2945640
UMLS CUI [8,3]
C2348568
unable to follow the study protocol
Beschrijving

Protocol Compliance Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
unable to speak, read and write in english
Beschrijving

Lacking Able to speak English Language | Lacking Able to read English Language | Lacking Able to write English Language

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0586740
UMLS CUI [2,3]
C0376245
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C0584993
UMLS CUI [3,3]
C0376245
pregnant, planning to become pregnant, breast feeding
Beschrijving

Pregnancy | Pregnancy, Planned | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
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Similar models

Eligibility Type 2 Diabetes NCT00993824

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female subjects ≥18 and ≤75 years of age
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
clinical diagnosis of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Metformin Dose Stable | Sulfonylurea Dose Stable | Combined Modality Therapy
Item
currently treated with metformin, a sulfonylurea, or combination metformin/sulfonylurea; stable dose for ≥3 months
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0009429 (UMLS CUI [3])
Hemoglobin A1c measurement
Item
hba1c of 7.0-9.0% inclusive
boolean
C0474680 (UMLS CUI [1])
Hypolipidemic Agents Dose Stable
Item
if taking lipid lowering medications, stable dose for >30 days
boolean
C0086440 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Prednisone Oral Product | Prednisone Injection | Cortisone Oral Product | Cortisone Injection | Topical steroids allowed | Inhaled steroids allowed
Item
taken oral or injected prednisone or cortisone medications in the previous 30 days. (topical or inhaled steroids will not be considered excluded medications.)
boolean
C3216040 (UMLS CUI [1])
C0032952 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
C3209977 (UMLS CUI [3])
C0010137 (UMLS CUI [4,1])
C1828121 (UMLS CUI [4,2])
C2064827 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C2065041 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
Insulin | Thiazolidinediones | Incretins
Item
current use of insulin or tzd's, or incretins
boolean
C0021641 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
C1562292 (UMLS CUI [3])
Low density lipoprotein measurement
Item
ldl <70 mg/dl
boolean
C0202116 (UMLS CUI [1])
Serum Triglyceride Measurement
Item
serum triglycerides >500 mg/dl
boolean
C0542495 (UMLS CUI [1])
Pancreatitis Hypertriglyceridemia Induced
Item
history of hypertriglyceridemia-induced pancreatitis
boolean
C0030305 (UMLS CUI [1,1])
C0020557 (UMLS CUI [1,2])
C0205263 (UMLS CUI [1,3])
Gastrointestinal Disease | Deglutition Disorders | Deranged intestinal motility | Intestinal Obstruction
Item
history of gastrointestinal disorder such as dysphagia, swallowing disorder, intestinal motility disorder or prior bowel obstruction
boolean
C0017178 (UMLS CUI [1])
C0011168 (UMLS CUI [2])
C0232673 (UMLS CUI [3])
C0021843 (UMLS CUI [4])
Medical condition Severe compromises Patient safety | Severe Mental Disorder compromises Patient safety | Chronic condition compromises Patient safety | Chronic infectious disease compromises Patient safety | Medical condition Severe compromises Study Subject Participation Status | Severe Mental Disorder compromises Study Subject Participation Status | Chronic condition compromises Study Subject Participation Status | Chronic infectious disease compromises Study Subject Participation Status
Item
history or presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the investigator would compromise the subject's safety or successful participation in the study
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C4046029 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C4315615 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0151317 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C1113679 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C2945640 (UMLS CUI [5,3])
C2348568 (UMLS CUI [5,4])
C4046029 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C4315615 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C2348568 (UMLS CUI [7,3])
C0151317 (UMLS CUI [8,1])
C2945640 (UMLS CUI [8,2])
C2348568 (UMLS CUI [8,3])
Protocol Compliance Unable
Item
unable to follow the study protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Lacking Able to speak English Language | Lacking Able to read English Language | Lacking Able to write English Language
Item
unable to speak, read and write in english
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C0586740 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
C0332268 (UMLS CUI [3,1])
C0584993 (UMLS CUI [3,2])
C0376245 (UMLS CUI [3,3])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
pregnant, planning to become pregnant, breast feeding
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
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