ID

29155

Beskrivning

Comparison of Nutritional Products for People With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00797069

Länk

https://clinicaltrials.gov/show/NCT00797069

Nyckelord

Versioner (1)
  1. 2018-03-02 2018-03-02 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

2 mars 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00797069

Engelsk

Eligibility Diabetes Mellitus, Type 2 NCT00797069

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months).
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent | Oral hypoglycemic

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0359086
2. subject is between 18 and 75 years of age, inclusive.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
Beskrivning

Gender | Pregnancy Absent | Breast Feeding Absent | Postpartum

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0086839
4. if female is of childbearing potential, is practicing a method of birth control.
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
5. subject's bmi is > 18.5 kg/m2 and < 35 kg/m2.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
6. if on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.
Beskrivning

Pharmaceutical Preparations chronic | Antihypertensive Agents Dosage Stable | Hypoglycemic Agents Dosage Stable | Thyroid preparations Dosage Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0020616
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C0279175
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject uses exogenous insulin for glucose control.
Beskrivning

Insulin Exogenous GLUCOSE CONTROL

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0205228
UMLS CUI [1,3]
C0726398
2. subject states that he/she has type 1 diabetes.
Beskrivning

Diabetes Mellitus, Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
3. subject states that he/she has a history of diabetic ketoacidosis.
Beskrivning

Diabetic Ketoacidosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0011880
4. subject takes an alpha-glucosidase inhibitor.
Beskrivning

alpha-Glucosidase Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C1299007
5. subject states that he/she has a current infection ; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
Beskrivning

Communicable Disease | Inpatient Operative Surgical Procedures | Adrenal Cortex Hormones | Antibiotics

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0021562
UMLS CUI [2,2]
C0543467
UMLS CUI [3]
C0001617
UMLS CUI [4]
C0003232
6. subject states that he/she has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
Beskrivning

Malignant Neoplasms | Exception Malignant Neoplasms Dermal Specified | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C0221928
UMLS CUI [2,4]
C0205369
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
7. subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
Beskrivning

Cardiovascular event | Congestive heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C1320716
UMLS CUI [2]
C0018802
8. subject states that he/she has end stage organ failure or is status post organ transplant.
Beskrivning

End-stage Organ failure | Status post Organ Transplantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205088
UMLS CUI [1,2]
C0349410
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0029216
9. subject states that he/she has a history of renal disease.
Beskrivning

Kidney Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0022658
10. subject states that he/she has current hepatic disease.
Beskrivning

Liver diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
11. subject states that he/she has a history of severe gastroparesis.
Beskrivning

Gastroparesis Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0152020
UMLS CUI [1,2]
C0205082
12. subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv.
Beskrivning

Chronic disease | Communicable Disease | Tuberculosis | Hepatitis B | Hepatitis C | HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0008679
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0041296
UMLS CUI [4]
C0019163
UMLS CUI [5]
C0019196
UMLS CUI [6]
C0019693
13. subject has taken/is currently taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose.
Beskrivning

Plant Preparations Affecting Blood Glucose | Dietary Supplements Affecting Blood Glucose | Pharmaceutical Preparations Affecting Blood Glucose | Exception Oral hypoglycemic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0949854
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005802
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0005802
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0005802
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0359086
14. subject states that he/she has clotting or bleeding disorders.
Beskrivning

Blood Coagulation Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0005779
15. subject is known to be allergic or intolerant to any ingredient found in the study products.
Beskrivning

Hypersensitivity Investigational New Drugs Ingredient | Intolerance to Investigational New Drugs Ingredient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1550600
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1550600
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00797069

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Oral hypoglycemic
Item
1. subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months).
boolean
C0011860 (UMLS CUI [1])
C0359086 (UMLS CUI [2])
Age
Item
2. subject is between 18 and 75 years of age, inclusive.
boolean
C0001779 (UMLS CUI [1])
Gender | Pregnancy Absent | Breast Feeding Absent | Postpartum
Item
3. subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0086839 (UMLS CUI [4])
Childbearing Potential Contraceptive methods
Item
4. if female is of childbearing potential, is practicing a method of birth control.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Body mass index
Item
5. subject's bmi is > 18.5 kg/m2 and < 35 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Pharmaceutical Preparations chronic | Antihypertensive Agents Dosage Stable | Hypoglycemic Agents Dosage Stable | Thyroid preparations Dosage Stable
Item
6. if on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.
boolean
C0013227 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0020616 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0279175 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Insulin Exogenous GLUCOSE CONTROL
Item
1. subject uses exogenous insulin for glucose control.
boolean
C0021641 (UMLS CUI [1,1])
C0205228 (UMLS CUI [1,2])
C0726398 (UMLS CUI [1,3])
Diabetes Mellitus, Insulin-Dependent
Item
2. subject states that he/she has type 1 diabetes.
boolean
C0011854 (UMLS CUI [1])
Diabetic Ketoacidosis
Item
3. subject states that he/she has a history of diabetic ketoacidosis.
boolean
C0011880 (UMLS CUI [1])
alpha-Glucosidase Inhibitors
Item
4. subject takes an alpha-glucosidase inhibitor.
boolean
C1299007 (UMLS CUI [1])
Communicable Disease | Inpatient Operative Surgical Procedures | Adrenal Cortex Hormones | Antibiotics
Item
5. subject states that he/she has a current infection ; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
boolean
C0009450 (UMLS CUI [1])
C0021562 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3])
C0003232 (UMLS CUI [4])
Malignant Neoplasms | Exception Malignant Neoplasms Dermal Specified | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix
Item
6. subject states that he/she has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0221928 (UMLS CUI [2,3])
C0205369 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
Cardiovascular event | Congestive heart failure
Item
7. subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
boolean
C1320716 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
End-stage Organ failure | Status post Organ Transplantation
Item
8. subject states that he/she has end stage organ failure or is status post organ transplant.
boolean
C0205088 (UMLS CUI [1,1])
C0349410 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0029216 (UMLS CUI [2,2])
Kidney Diseases
Item
9. subject states that he/she has a history of renal disease.
boolean
C0022658 (UMLS CUI [1])
Liver diseases
Item
10. subject states that he/she has current hepatic disease.
boolean
C0023895 (UMLS CUI [1])
Gastroparesis Severe
Item
11. subject states that he/she has a history of severe gastroparesis.
boolean
C0152020 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Chronic disease | Communicable Disease | Tuberculosis | Hepatitis B | Hepatitis C | HIV Infection
Item
12. subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv.
boolean
C0008679 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C0041296 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
C0019196 (UMLS CUI [5])
C0019693 (UMLS CUI [6])
Plant Preparations Affecting Blood Glucose | Dietary Supplements Affecting Blood Glucose | Pharmaceutical Preparations Affecting Blood Glucose | Exception Oral hypoglycemic
Item
13. subject has taken/is currently taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose.
boolean
C0949854 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005802 (UMLS CUI [1,3])
C0242295 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0005802 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0005802 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0359086 (UMLS CUI [4,2])
Blood Coagulation Disorders
Item
14. subject states that he/she has clotting or bleeding disorders.
boolean
C0005779 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs Ingredient | Intolerance to Investigational New Drugs Ingredient
Item
15. subject is known to be allergic or intolerant to any ingredient found in the study products.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
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