ID

29144

Beschrijving

Effects of Nutritional Products on Blood Glucose in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00753181

Link

https://clinicaltrials.gov/show/NCT00753181

Trefwoorden

Versies (1)
  1. 01-03-18 01-03-18 -
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See clinicaltrials.gov

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1 maart 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00753181

Engels

Eligibility Diabetes Mellitus, Type 2 NCT00753181

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. type 2 diabetes
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
2. hba1c >6.5% and <11.0%
Beschrijving

Glucohemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202054
3. male/non-pregnant, non-lactating female, at least 6 months postpartum
Beschrijving

Gender | Pregnancy Absent | Breast Feeding Absent | Postpartum

Datatype

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 of childbearing potential, practicing method of birth control
Beschrijving

Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
5. body mass index > 18.5 kg/m2 and < 43.0 kg/m2.
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
6. weight stable for past two months
Beschrijving

Stable body weight Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0517386
UMLS CUI [1,2]
C0449238
7. if on anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, dosage constant for at least two months
Beschrijving

Antihypertensive Agents Dosage Stable | Hypoglycemic Agents Dosage Stable | Antithyroid Agents Dosage Stable | Hormone Therapy Dosage Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0020616
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0040125
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C0279025
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. uses injected medications (e.g., insulin, exenatide) for glucose control.
Beschrijving

Pharmaceutical Preparations Injection Blood Glucose Control | Insulin | exenatide

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1828121
UMLS CUI [1,3]
C0005802
UMLS CUI [1,4]
C0243148
UMLS CUI [2]
C0021641
UMLS CUI [3]
C0167117
2. history of diabetic ketoacidosis
Beschrijving

Diabetic Ketoacidosis

Datatype

boolean

Alias
UMLS CUI [1]
C0011880
3. current infection ; inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0021562
UMLS CUI [2,2]
C0543467
UMLS CUI [3]
C0001617
UMLS CUI [4]
C0003232
4. active malignancy
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
5. states he/she has had a significant cardiovascular event < 12 weeks prior to study entry or history of congestive heart failure in the last 12 months.
Beschrijving

Cardiovascular event | Congestive heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C1320716
UMLS CUI [2]
C0018802
6. end stage organ failure
Beschrijving

Organ failure End-stage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0349410
UMLS CUI [1,2]
C0205088
7. active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion (such as gastroparesis), excluding diabetes.
Beschrijving

Metabolic Disease Interferes with Nutrient absorption | Liver disease Interferes with Nutrient absorption | Gastrointestinal Disease Interferes with Nutrient absorption | Metabolic Disease Interferes with Nutrients Distribution | Liver disease Interferes with Nutrients Distribution | Gastrointestinal Disease Interferes with Nutrients Distribution | Metabolic Disease Interferes with Nutrients Metabolism | Liver disease Interferes with Nutrients Metabolism | Gastrointestinal Disease Interferes with Nutrients Metabolism | Metabolic Disease Interferes with Nutrients Excretion | Liver disease Interferes with Nutrients Excretion | Gastrointestinal Disease Interferes with Nutrients Excretion | Gastroparesis | Exception Diabetes

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025517
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1961155
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1961155
UMLS CUI [3,1]
C0017178
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1961155
UMLS CUI [4,1]
C0025517
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0678695
UMLS CUI [4,4]
C1378698
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0678695
UMLS CUI [5,4]
C1378698
UMLS CUI [6,1]
C0017178
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0678695
UMLS CUI [6,4]
C1378698
UMLS CUI [7,1]
C0025517
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0678695
UMLS CUI [7,4]
C0025519
UMLS CUI [8,1]
C0023895
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0678695
UMLS CUI [8,4]
C0025519
UMLS CUI [9,1]
C0017178
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C0678695
UMLS CUI [9,4]
C0025519
UMLS CUI [10,1]
C0025517
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C0678695
UMLS CUI [10,4]
C0221102
UMLS CUI [11,1]
C0023895
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0678695
UMLS CUI [11,4]
C0221102
UMLS CUI [12,1]
C0017178
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C0678695
UMLS CUI [12,4]
C0221102
UMLS CUI [13]
C0152020
UMLS CUI [14,1]
C1705847
UMLS CUI [14,2]
C0011847
8. chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv.
Beschrijving

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

Datatype

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
9. use of herbals, dietary supplements, or medications, other than allowed medications, during past four weeks that could profoundly affect blood glucose.
Beschrijving

Plant Preparations Affecting Blood Glucose | Dietary Supplements Affecting Blood Glucose | Pharmaceutical Preparations Illicit Affecting Blood Glucose

Datatype

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]
C0332266
UMLS CUI [3,3]
C0392760
UMLS CUI [3,4]
C0005802
10. symptomatic in response to blood collection prior to enrollment into this study.
Beschrijving

Response Symptomatic Collection of blood specimen

Datatype

boolean

Alias
UMLS CUI [1,1]
C0871261
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0005834
11. clotting or bleeding disorders.
Beschrijving

Blood Coagulation Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0005779
12. non-typical eating pattern
Beschrijving

Abnormal eating pattern

Datatype

boolean

Alias
UMLS CUI [1]
C0586278
13. is currently using diabetes-specific nutritional product(s)defined as more than one eating occasion per week.
Beschrijving

Nutritional products Diabetes Specific | Meal (occasion for eating) times/week

Datatype

boolean

Alias
UMLS CUI [1,1]
C4036031
UMLS CUI [1,2]
C0011847
UMLS CUI [1,3]
C0205369
UMLS CUI [2,1]
C1998602
UMLS CUI [2,2]
C0456698
14. engages in strenuous exercise five or more times per week.
Beschrijving

Strenuous Exercise times/week

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514989
UMLS CUI [1,2]
C0456698
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00753181

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
1. type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Glucohemoglobin measurement
Item
2. hba1c >6.5% and <11.0%
boolean
C0202054 (UMLS CUI [1])
Gender | Pregnancy Absent | Breast Feeding Absent | Postpartum
Item
3. male/non-pregnant, non-lactating female, at least 6 months postpartum
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 of childbearing potential, practicing method of birth control
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Body mass index
Item
5. body mass index > 18.5 kg/m2 and < 43.0 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Stable body weight Duration
Item
6. weight stable for past two months
boolean
C0517386 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Antihypertensive Agents Dosage Stable | Hypoglycemic Agents Dosage Stable | Antithyroid Agents Dosage Stable | Hormone Therapy Dosage Stable
Item
7. if on anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, dosage constant for at least two months
boolean
C0003364 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0020616 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0040125 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0279025 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Injection Blood Glucose Control | Insulin | exenatide
Item
1. uses injected medications (e.g., insulin, exenatide) for glucose control.
boolean
C0013227 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C0005802 (UMLS CUI [1,3])
C0243148 (UMLS CUI [1,4])
C0021641 (UMLS CUI [2])
C0167117 (UMLS CUI [3])
Diabetic Ketoacidosis
Item
2. history of diabetic ketoacidosis
boolean
C0011880 (UMLS CUI [1])
Communicable Disease | Inpatient Operative Surgical Procedures | Adrenal Cortex Hormones | Antibiotics
Item
3. current infection ; inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks
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
Item
4. active malignancy
boolean
C0006826 (UMLS CUI [1])
Cardiovascular event | Congestive heart failure
Item
5. states he/she has had a significant cardiovascular event < 12 weeks prior to study entry or history of congestive heart failure in the last 12 months.
boolean
C1320716 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
Organ failure End-stage
Item
6. end stage organ failure
boolean
C0349410 (UMLS CUI [1,1])
C0205088 (UMLS CUI [1,2])
Metabolic Disease Interferes with Nutrient absorption | Liver disease Interferes with Nutrient absorption | Gastrointestinal Disease Interferes with Nutrient absorption | Metabolic Disease Interferes with Nutrients Distribution | Liver disease Interferes with Nutrients Distribution | Gastrointestinal Disease Interferes with Nutrients Distribution | Metabolic Disease Interferes with Nutrients Metabolism | Liver disease Interferes with Nutrients Metabolism | Gastrointestinal Disease Interferes with Nutrients Metabolism | Metabolic Disease Interferes with Nutrients Excretion | Liver disease Interferes with Nutrients Excretion | Gastrointestinal Disease Interferes with Nutrients Excretion | Gastroparesis | Exception Diabetes
Item
7. active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion (such as gastroparesis), excluding diabetes.
boolean
C0025517 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1961155 (UMLS CUI [1,3])
C0023895 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1961155 (UMLS CUI [2,3])
C0017178 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1961155 (UMLS CUI [3,3])
C0025517 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0678695 (UMLS CUI [4,3])
C1378698 (UMLS CUI [4,4])
C0023895 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0678695 (UMLS CUI [5,3])
C1378698 (UMLS CUI [5,4])
C0017178 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0678695 (UMLS CUI [6,3])
C1378698 (UMLS CUI [6,4])
C0025517 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0678695 (UMLS CUI [7,3])
C0025519 (UMLS CUI [7,4])
C0023895 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0678695 (UMLS CUI [8,3])
C0025519 (UMLS CUI [8,4])
C0017178 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C0678695 (UMLS CUI [9,3])
C0025519 (UMLS CUI [9,4])
C0025517 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C0678695 (UMLS CUI [10,3])
C0221102 (UMLS CUI [10,4])
C0023895 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0678695 (UMLS CUI [11,3])
C0221102 (UMLS CUI [11,4])
C0017178 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0678695 (UMLS CUI [12,3])
C0221102 (UMLS CUI [12,4])
C0152020 (UMLS CUI [13])
C1705847 (UMLS CUI [14,1])
C0011847 (UMLS CUI [14,2])
Chronic disease | Communicable Disease | Tuberculosis | Hepatitis B | Hepatitis C | HIV Infection
Item
8. 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 Illicit Affecting Blood Glucose
Item
9. use of herbals, dietary supplements, or medications, other than allowed medications, during past four weeks 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])
C0332266 (UMLS CUI [3,2])
C0392760 (UMLS CUI [3,3])
C0005802 (UMLS CUI [3,4])
Response Symptomatic Collection of blood specimen
Item
10. symptomatic in response to blood collection prior to enrollment into this study.
boolean
C0871261 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
Blood Coagulation Disorders
Item
11. clotting or bleeding disorders.
boolean
C0005779 (UMLS CUI [1])
Abnormal eating pattern
Item
12. non-typical eating pattern
boolean
C0586278 (UMLS CUI [1])
Nutritional products Diabetes Specific | Meal (occasion for eating) times/week
Item
13. is currently using diabetes-specific nutritional product(s)defined as more than one eating occasion per week.
boolean
C4036031 (UMLS CUI [1,1])
C0011847 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C1998602 (UMLS CUI [2,1])
C0456698 (UMLS CUI [2,2])
Strenuous Exercise times/week
Item
14. engages in strenuous exercise five or more times per week.
boolean
C1514989 (UMLS CUI [1,1])
C0456698 (UMLS CUI [1,2])
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