ID

23430

Beskrivning

Effect of Nuts vs. a Wheat Bran Muffin in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00410722

Länk

https://clinicaltrials.gov/show/NCT00410722

Nyckelord

Versioner (1)
  1. 2017-07-04 2017-07-04 -
Uppladdad den

4 juli 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00410722

Engelsk

Eligibility Type 2 Diabetes NCT00410722

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and post menopausal women with type 2 diabetes treated with diet plus oral hypoglycemic agents (sulfonylureas (glyburide), biguanides (metformin), thiazolidinediones (tzds) and new secretagogues (repaglinide)) at a stable dose for at least 3 months prior to starting the study;
Beskrivning

Gender | Postmenopausal state | Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Oral hypoglycemic Dose Stable | Sulfonylurea | Glyburide | Biguanides | Metformin | Thiazolidinediones | repaglinide

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0011860
UMLS CUI [4]
C0012159
UMLS CUI [5,1]
C0359086
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0205360
UMLS CUI [6]
C0038766
UMLS CUI [7]
C0017628
UMLS CUI [8]
C0005382
UMLS CUI [9]
C0025598
UMLS CUI [10]
C1257987
UMLS CUI [11]
C0246689
hba1c of 6.5 to 8.0% as a compromise between those whose levels are acceptable and the level which is currently considered unacceptable.
Beskrivning

Glycosylated hemoglobin A

Datatyp

boolean

Alias
UMLS CUI [1]
C0019018
diabetes diagnosed >6 months prior to randomization
Beskrivning

Diabetes Mellitus disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0872146
weight stable within 3% body weight >2 months.
Beskrivning

Stable body weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0517386
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of acarbose
Beskrivning

Acarbose

Datatyp

boolean

Alias
UMLS CUI [1]
C0050393
use of insulin
Beskrivning

Insulin

Datatyp

boolean

Alias
UMLS CUI [1]
C0021641
known nut allergies
Beskrivning

Nut Hypersensitivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0577620
clinically significant gastroparesis
Beskrivning

Gastroparesis

Datatyp

boolean

Alias
UMLS CUI [1]
C0152020
use of steroids
Beskrivning

Steroids

Datatyp

boolean

Alias
UMLS CUI [1]
C0038317
presence of gi disease (celiac disease, ulcerative colitis, and crohns)
Beskrivning

Gastrointestinal Diseases | Celiac Disease | Ulcerative Colitis | Crohn Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0007570
UMLS CUI [3]
C0009324
UMLS CUI [4]
C0010346
major cardiovascular event (stroke or myocardial infarction)
Beskrivning

Cardiovascular event Major | Cerebrovascular accident | Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0027051
major surgery < 6 months prior to randomization
Beskrivning

major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
presence of major debilitating disorder such as clinically significant liver disease (not including non-alcoholic fatty liver (nafl) or non-alcoholic steatohepatitis (nash) but including cirrhosis, infectious hepatitis (b and c), aspartate transaminase (ast) or alanine transaminase (alt) > 130 iu/l)
Beskrivning

Debilitation Major | Liver diseases | Non-alcoholic Fatty Liver Disease | Nonalcoholic Steatohepatitis | Liver Cirrhosis | HEPATITIS B INFECTIOUS | Hepatitis C | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0742985
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0400966
UMLS CUI [4]
C3241937
UMLS CUI [5]
C0023890
UMLS CUI [6]
C0744836
UMLS CUI [7]
C0019196
UMLS CUI [8]
C0201899
UMLS CUI [9]
C0201836
renal failure (high creatinine > 150 mmol/l)
Beskrivning

Kidney Failure | Creatinine increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0151578
serum triglyceride > 6 mmol/l.
Beskrivning

Serum Triglyceride Measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0542495
patients currently undergoing treatment for cancer with the exception of non-melanoma skin cancer, but not high risk patients or those whose treatment has been successfully completed.
Beskrivning

Cancer treatment | Skin carcinoma | High risk Absent | Treatment completed Successful

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0699893
UMLS CUI [3,1]
C0332167
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0580352
UMLS CUI [4,2]
C1272703
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Similar models

Eligibility Type 2 Diabetes NCT00410722

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Postmenopausal state | Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Oral hypoglycemic Dose Stable | Sulfonylurea | Glyburide | Biguanides | Metformin | Thiazolidinediones | repaglinide
Item
men and post menopausal women with type 2 diabetes treated with diet plus oral hypoglycemic agents (sulfonylureas (glyburide), biguanides (metformin), thiazolidinediones (tzds) and new secretagogues (repaglinide)) at a stable dose for at least 3 months prior to starting the study;
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
C0012159 (UMLS CUI [4])
C0359086 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
C0038766 (UMLS CUI [6])
C0017628 (UMLS CUI [7])
C0005382 (UMLS CUI [8])
C0025598 (UMLS CUI [9])
C1257987 (UMLS CUI [10])
C0246689 (UMLS CUI [11])
Glycosylated hemoglobin A
Item
hba1c of 6.5 to 8.0% as a compromise between those whose levels are acceptable and the level which is currently considered unacceptable.
boolean
C0019018 (UMLS CUI [1])
Diabetes Mellitus disease length
Item
diabetes diagnosed >6 months prior to randomization
boolean
C0011849 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Stable body weight
Item
weight stable within 3% body weight >2 months.
boolean
C0517386 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acarbose
Item
use of acarbose
boolean
C0050393 (UMLS CUI [1])
Insulin
Item
use of insulin
boolean
C0021641 (UMLS CUI [1])
Nut Hypersensitivity
Item
known nut allergies
boolean
C0577620 (UMLS CUI [1])
Gastroparesis
Item
clinically significant gastroparesis
boolean
C0152020 (UMLS CUI [1])
Steroids
Item
use of steroids
boolean
C0038317 (UMLS CUI [1])
Gastrointestinal Diseases | Celiac Disease | Ulcerative Colitis | Crohn Disease
Item
presence of gi disease (celiac disease, ulcerative colitis, and crohns)
boolean
C0017178 (UMLS CUI [1])
C0007570 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
C0010346 (UMLS CUI [4])
Cardiovascular event Major | Cerebrovascular accident | Myocardial Infarction
Item
major cardiovascular event (stroke or myocardial infarction)
boolean
C1320716 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
major surgery
Item
major surgery < 6 months prior to randomization
boolean
C0679637 (UMLS CUI [1])
Debilitation Major | Liver diseases | Non-alcoholic Fatty Liver Disease | Nonalcoholic Steatohepatitis | Liver Cirrhosis | HEPATITIS B INFECTIOUS | Hepatitis C | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
presence of major debilitating disorder such as clinically significant liver disease (not including non-alcoholic fatty liver (nafl) or non-alcoholic steatohepatitis (nash) but including cirrhosis, infectious hepatitis (b and c), aspartate transaminase (ast) or alanine transaminase (alt) > 130 iu/l)
boolean
C0742985 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2])
C0400966 (UMLS CUI [3])
C3241937 (UMLS CUI [4])
C0023890 (UMLS CUI [5])
C0744836 (UMLS CUI [6])
C0019196 (UMLS CUI [7])
C0201899 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
Kidney Failure | Creatinine increased
Item
renal failure (high creatinine > 150 mmol/l)
boolean
C0035078 (UMLS CUI [1])
C0151578 (UMLS CUI [2])
Serum Triglyceride Measurement
Item
serum triglyceride > 6 mmol/l.
boolean
C0542495 (UMLS CUI [1])
Cancer treatment | Skin carcinoma | High risk Absent | Treatment completed Successful
Item
patients currently undergoing treatment for cancer with the exception of non-melanoma skin cancer, but not high risk patients or those whose treatment has been successfully completed.
boolean
C0920425 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0332167 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0580352 (UMLS CUI [4,1])
C1272703 (UMLS CUI [4,2])
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