ID

29144

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00753181

Nyckelord

Versioner (1)
  1. 2018-03-01 2018-03-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 mars 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Diabetes Mellitus, Type 2 NCT00753181

Engelsk

Eligibility Diabetes Mellitus, Type 2 NCT00753181

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. type 2 diabetes
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

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

Glucohemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202054
3. male/non-pregnant, non-lactating female, at least 6 months postpartum
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 of childbearing potential, practicing method of birth control
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

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.
Beskrivning

Body mass index

Datatyp

boolean

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

Stable body weight Duration

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Exclusion Criteria

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

Pharmaceutical Preparations Injection Blood Glucose Control | Insulin | exenatide

Datatyp

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
Beskrivning

Diabetic Ketoacidosis

Datatyp

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
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
4. active malignancy
Beskrivning

Malignant Neoplasms

Datatyp

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.
Beskrivning

Cardiovascular event | Congestive heart failure

Datatyp

boolean

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

Organ failure End-stage

Datatyp

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.
Beskrivning

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

Datatyp

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

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

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

Response Symptomatic Collection of blood specimen

Datatyp

boolean

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

Blood Coagulation Disorders

Datatyp

boolean

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

Abnormal eating pattern

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

Strenuous Exercise times/week

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514989
UMLS CUI [1,2]
C0456698
Tillbaka till toppen

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00753181

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial