ID

32877

Beschreibung

Dance Dance Revolution (DDR) in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00851019

Link

https://clinicaltrials.gov/show/NCT00851019

Stichworte

Versionen (2)
  1. 18.11.18 18.11.18 -
  2. 19.11.18 19.11.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

18. November 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Type 2 Diabetes Mellitus NCT00851019

Englisch

Eligibility Type 2 Diabetes Mellitus NCT00851019

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 to 65 inclusive
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed type 2 diabetes mellitus (by ada diagnostic criteria) for at least 1 year
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
on stable doses of oral anti-hyperglycemic medications for at least 3 months (i.e., sulfonylureas, metformin, thiazolidinediones, and/or dpp-4 inhibitors; glp-1 analogues may also be permitted)
Beschreibung

Oral hypoglycemic Dose Stable | Sulfonylureas | Metformin | Thiazolidinediones | Dipeptidyl-Peptidase IV Inhibitors | GLP-1 analogues

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0038766
UMLS CUI [3]
C0025598
UMLS CUI [4]
C1257987
UMLS CUI [5]
C1827106
UMLS CUI [6]
C4301632
hemoglobin a1c level between 7.5% and 9.0% inclusive
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) between 25.0 and 40.0 kg/m2 inclusive
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
able to engage in a regular program of mild-to-moderate intensity physical activity
Beschreibung

Participation Program Physical activity Mild | Participation Program Moderate physical activity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C3484370
UMLS CUI [1,3]
C0026606
UMLS CUI [1,4]
C2945599
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C3484370
UMLS CUI [2,3]
C4482418
subjects not currently engaged in any regimented exercise program outside of the usual activities of daily living that is intended to achieve metabolic changes (e.g., weight loss, athletic training, etc.)
Beschreibung

Absence Exercise Change Metabolic | Weight Reduction Program Absent | Athletic training Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0015259
UMLS CUI [1,3]
C0392747
UMLS CUI [1,4]
C0311400
UMLS CUI [2,1]
C3179079
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0237919
UMLS CUI [3,2]
C0332197
able to give informed consent and cooperate with all necessary procedures of the study
Beschreibung

Informed Consent | Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any contraindications to a regular program of mild-to-moderate intensity exercise, or any cardiovascular, pulmonary, orthopedic, rheumatological or neurological conditions that may, in the opinion of the investigators, interfere with the subject's optimal participation in a regular exercise program, interfere with the quality of the data collected from the subject, or make a regular exercise program potentially hazardous
Beschreibung

Medical contraindication Exercise Mild | Medical contraindication Moderate Exercise | Cardiovascular Diseases | Lung diseases | Orthopedic problem | Rheumatism | Nervous system disorder | Condition Interferes with Participation Exercise | Condition Interferes with Patient data Quality | Condition Exercise At risk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0015259
UMLS CUI [1,3]
C2945599
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1513375
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0024115
UMLS CUI [5]
C0029354
UMLS CUI [6]
C0035435
UMLS CUI [7]
C0027765
UMLS CUI [8,1]
C0348080
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0679823
UMLS CUI [8,4]
C0015259
UMLS CUI [9,1]
C0348080
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C2707520
UMLS CUI [9,4]
C0332306
UMLS CUI [10,1]
C0348080
UMLS CUI [10,2]
C0015259
UMLS CUI [10,3]
C1444641
diabetes mellitus currently being treated with insulin and/or pramlintide
Beschreibung

Insulin regime Diabetes Mellitus | Pramlintide

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0011849
UMLS CUI [2]
C0537551
screening fasting plasma glucose (fpg) 300 mg/dl or greater or symptoms of hyperglycemia (polyuria, polydipsia); screening fpg < 60 mg dl, or a history of symptomatic hypoglycemia averaging more than once per day; or any other history suggestive of erratic glucose control
Beschreibung

Plasma fasting glucose measurement | Symptoms Hyperglycemia | Polyuria | Polydipsia | HYPOGLYCEMIA SYMPTOMATIC | Medical History Suggestive of GLUCOSE CONTROL Unstable

Datentyp

boolean

Alias
UMLS CUI [1]
C0583513
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0020456
UMLS CUI [3]
C0032617
UMLS CUI [4]
C0085602
UMLS CUI [5]
C0745152
UMLS CUI [6,1]
C0262926
UMLS CUI [6,2]
C0332299
UMLS CUI [6,3]
C0726398
UMLS CUI [6,4]
C0443343
screening fasting triglycerides 500 mg/dl or greater; or ldl-cholesterol 200 mg/dl or greater; screening blood pressure averaging 180 mm hg or greater systolic or 100 mm hg or greater diastolic
Beschreibung

Serum fasting triglyceride measurement | Serum LDL cholesterol measurement | Average blood pressure | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0582824
UMLS CUI [2]
C0428474
UMLS CUI [3]
C4301973
UMLS CUI [4]
C0871470
UMLS CUI [5]
C0428883
subjects currently engaged in any regimented exercise program outside of the usual activities of daily living that is intended to achieve metabolic changes (e.g., weight loss, athletic training, etc.); any such activities occurring on a sporadic basis may still disqualify the subject, depending upon its frequency, to be judged at the discretion of the pi. subjects must maintain their usual occupational and other routine daily activities during the study at a reasonably constant level.
Beschreibung

Participation Exercise | Change Metabolic intended | Weight decreased | Athletic training | Requirement Maintenance Activities of Daily Living

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0015259
UMLS CUI [2,1]
C0392747
UMLS CUI [2,2]
C0311400
UMLS CUI [2,3]
C1283828
UMLS CUI [3]
C1262477
UMLS CUI [4]
C0237919
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C0024501
UMLS CUI [5,3]
C0001288
subjects who routinely engage in ddr, either at home or video game arcades; "occasional" participation in ddr may still disqualify the subject, depending upon the frequency of participation, to be judged at the discretion of the pi
Beschreibung

Other Coding

Datentyp

boolean

Alias
UMLS CUI [1]
C3846158
changing doses of any concurrent medications that are known to alter the study's outcomes (e.g., oral anti-hyperglycemic agents, lipid-lowering agents, weight loss agents, anti-hypertensive agents, systemic glucocorticoids, thyroid medications, hormone replacement therapies, oral contraceptives, etc.) or the anticipated need to start any of these medications; such medications taken concurrently must remain at constant dosages throughout the study.
Beschreibung

Medication dose changed Research results altered | Oral hypoglycemic | Hypolipidemic Agents | Weight-Loss Agents | Antihypertensive Agents | Glucocorticoids, Systemic | Thyroid preparations | Hormone replacement therapy | Contraceptives, Oral | Medication dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1608430
UMLS CUI [1,2]
C0683954
UMLS CUI [1,3]
C0392747
UMLS CUI [2]
C0359086
UMLS CUI [3]
C0086440
UMLS CUI [4]
C0376606
UMLS CUI [5]
C0003364
UMLS CUI [6]
C3540777
UMLS CUI [7]
C0279175
UMLS CUI [8]
C0282402
UMLS CUI [9]
C0009905
UMLS CUI [10,1]
C3174092
UMLS CUI [10,2]
C0205360
past history of clinically significant dysfunction of other organ systems (e.g., known hepatic disease or hepatic transaminase levels greater than 3x the upper limit of the normal range other than steatohepatitis; known renal dysfunction or creatinine level 1.5 mg/dl or greater; past history of malignancies excluding cutaneous basal cell carcinoma; known chronic infections including hiv, endocrinopathies such as untreated thyroid disease, adrenal disease, or pituitary dysfunction, etc.), or any recent surgeries that preclude regular exercise, in the opinion of the investigators
Beschreibung

Organ dysfunction | Liver disease | Elevated hepatic transaminases | Exception Steatohepatitis | Renal dysfunction | Creatinine measurement, serum | Malignant Neoplasms | Exception Basal cell carcinoma | Chronic infectious disease | HIV Infection | Endocrine System Diseases | Thyroid Diseases Untreated | Adrenal Diseases | Pituitary dysfunction | Operative Surgical Procedures Preventing Exercise

Datentyp

boolean

Alias
UMLS CUI [1]
C0349410
UMLS CUI [2]
C0023895
UMLS CUI [3]
C1848701
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C2711227
UMLS CUI [5]
C3279454
UMLS CUI [6]
C0201976
UMLS CUI [7]
C0006826
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0007117
UMLS CUI [9]
C0151317
UMLS CUI [10]
C0019693
UMLS CUI [11]
C0014130
UMLS CUI [12,1]
C0040128
UMLS CUI [12,2]
C0332155
UMLS CUI [13]
C0001621
UMLS CUI [14]
C0281947
UMLS CUI [15,1]
C0543467
UMLS CUI [15,2]
C1292733
UMLS CUI [15,3]
C0015259
active hemolytic anemia, known hemoglobinopathies, or any other state of accelerated rbc turnover that may alter the accuracy of the hba1c measurement
Beschreibung

Anemia, Hemolytic | Hemoglobinopathies | RBC Turnover Accelerated | Hemoglobin A1c measurement Accuracy altered

Datentyp

boolean

Alias
UMLS CUI [1]
C0002878
UMLS CUI [2]
C0019045
UMLS CUI [3,1]
C0014792
UMLS CUI [3,2]
C0243127
UMLS CUI [3,3]
C0521110
UMLS CUI [4,1]
C0474680
UMLS CUI [4,2]
C0443131
UMLS CUI [4,3]
C0392747
pregnancy or lactation
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Type 2 Diabetes Mellitus NCT00851019

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 to 65 inclusive
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosed type 2 diabetes mellitus (by ada diagnostic criteria) for at least 1 year
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Oral hypoglycemic Dose Stable | Sulfonylureas | Metformin | Thiazolidinediones | Dipeptidyl-Peptidase IV Inhibitors | GLP-1 analogues
Item
on stable doses of oral anti-hyperglycemic medications for at least 3 months (i.e., sulfonylureas, metformin, thiazolidinediones, and/or dpp-4 inhibitors; glp-1 analogues may also be permitted)
boolean
C0359086 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C1257987 (UMLS CUI [4])
C1827106 (UMLS CUI [5])
C4301632 (UMLS CUI [6])
Hemoglobin A1c measurement
Item
hemoglobin a1c level between 7.5% and 9.0% inclusive
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) between 25.0 and 40.0 kg/m2 inclusive
boolean
C1305855 (UMLS CUI [1])
Participation Program Physical activity Mild | Participation Program Moderate physical activity
Item
able to engage in a regular program of mild-to-moderate intensity physical activity
boolean
C0679823 (UMLS CUI [1,1])
C3484370 (UMLS CUI [1,2])
C0026606 (UMLS CUI [1,3])
C2945599 (UMLS CUI [1,4])
C0679823 (UMLS CUI [2,1])
C3484370 (UMLS CUI [2,2])
C4482418 (UMLS CUI [2,3])
Absence Exercise Change Metabolic | Weight Reduction Program Absent | Athletic training Absent
Item
subjects not currently engaged in any regimented exercise program outside of the usual activities of daily living that is intended to achieve metabolic changes (e.g., weight loss, athletic training, etc.)
boolean
C0332197 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0311400 (UMLS CUI [1,4])
C3179079 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0237919 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Informed Consent | Protocol Compliance
Item
able to give informed consent and cooperate with all necessary procedures of the study
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Exercise Mild | Medical contraindication Moderate Exercise | Cardiovascular Diseases | Lung diseases | Orthopedic problem | Rheumatism | Nervous system disorder | Condition Interferes with Participation Exercise | Condition Interferes with Patient data Quality | Condition Exercise At risk
Item
any contraindications to a regular program of mild-to-moderate intensity exercise, or any cardiovascular, pulmonary, orthopedic, rheumatological or neurological conditions that may, in the opinion of the investigators, interfere with the subject's optimal participation in a regular exercise program, interfere with the quality of the data collected from the subject, or make a regular exercise program potentially hazardous
boolean
C1301624 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C2945599 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C1513375 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0029354 (UMLS CUI [5])
C0035435 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
C0348080 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0679823 (UMLS CUI [8,3])
C0015259 (UMLS CUI [8,4])
C0348080 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C2707520 (UMLS CUI [9,3])
C0332306 (UMLS CUI [9,4])
C0348080 (UMLS CUI [10,1])
C0015259 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
Insulin regime Diabetes Mellitus | Pramlintide
Item
diabetes mellitus currently being treated with insulin and/or pramlintide
boolean
C0557978 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0537551 (UMLS CUI [2])
Plasma fasting glucose measurement | Symptoms Hyperglycemia | Polyuria | Polydipsia | HYPOGLYCEMIA SYMPTOMATIC | Medical History Suggestive of GLUCOSE CONTROL Unstable
Item
screening fasting plasma glucose (fpg) 300 mg/dl or greater or symptoms of hyperglycemia (polyuria, polydipsia); screening fpg < 60 mg dl, or a history of symptomatic hypoglycemia averaging more than once per day; or any other history suggestive of erratic glucose control
boolean
C0583513 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0020456 (UMLS CUI [2,2])
C0032617 (UMLS CUI [3])
C0085602 (UMLS CUI [4])
C0745152 (UMLS CUI [5])
C0262926 (UMLS CUI [6,1])
C0332299 (UMLS CUI [6,2])
C0726398 (UMLS CUI [6,3])
C0443343 (UMLS CUI [6,4])
Serum fasting triglyceride measurement | Serum LDL cholesterol measurement | Average blood pressure | Systolic Pressure | Diastolic blood pressure
Item
screening fasting triglycerides 500 mg/dl or greater; or ldl-cholesterol 200 mg/dl or greater; screening blood pressure averaging 180 mm hg or greater systolic or 100 mm hg or greater diastolic
boolean
C0582824 (UMLS CUI [1])
C0428474 (UMLS CUI [2])
C4301973 (UMLS CUI [3])
C0871470 (UMLS CUI [4])
C0428883 (UMLS CUI [5])
Participation Exercise | Change Metabolic intended | Weight decreased | Athletic training | Requirement Maintenance Activities of Daily Living
Item
subjects currently engaged in any regimented exercise program outside of the usual activities of daily living that is intended to achieve metabolic changes (e.g., weight loss, athletic training, etc.); any such activities occurring on a sporadic basis may still disqualify the subject, depending upon its frequency, to be judged at the discretion of the pi. subjects must maintain their usual occupational and other routine daily activities during the study at a reasonably constant level.
boolean
C0679823 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C0392747 (UMLS CUI [2,1])
C0311400 (UMLS CUI [2,2])
C1283828 (UMLS CUI [2,3])
C1262477 (UMLS CUI [3])
C0237919 (UMLS CUI [4])
C1514873 (UMLS CUI [5,1])
C0024501 (UMLS CUI [5,2])
C0001288 (UMLS CUI [5,3])
Other Coding
Item
subjects who routinely engage in ddr, either at home or video game arcades; "occasional" participation in ddr may still disqualify the subject, depending upon the frequency of participation, to be judged at the discretion of the pi
boolean
C3846158 (UMLS CUI [1])
Medication dose changed Research results altered | Oral hypoglycemic | Hypolipidemic Agents | Weight-Loss Agents | Antihypertensive Agents | Glucocorticoids, Systemic | Thyroid preparations | Hormone replacement therapy | Contraceptives, Oral | Medication dose Stable
Item
changing doses of any concurrent medications that are known to alter the study's outcomes (e.g., oral anti-hyperglycemic agents, lipid-lowering agents, weight loss agents, anti-hypertensive agents, systemic glucocorticoids, thyroid medications, hormone replacement therapies, oral contraceptives, etc.) or the anticipated need to start any of these medications; such medications taken concurrently must remain at constant dosages throughout the study.
boolean
C1608430 (UMLS CUI [1,1])
C0683954 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0359086 (UMLS CUI [2])
C0086440 (UMLS CUI [3])
C0376606 (UMLS CUI [4])
C0003364 (UMLS CUI [5])
C3540777 (UMLS CUI [6])
C0279175 (UMLS CUI [7])
C0282402 (UMLS CUI [8])
C0009905 (UMLS CUI [9])
C3174092 (UMLS CUI [10,1])
C0205360 (UMLS CUI [10,2])
Organ dysfunction | Liver disease | Elevated hepatic transaminases | Exception Steatohepatitis | Renal dysfunction | Creatinine measurement, serum | Malignant Neoplasms | Exception Basal cell carcinoma | Chronic infectious disease | HIV Infection | Endocrine System Diseases | Thyroid Diseases Untreated | Adrenal Diseases | Pituitary dysfunction | Operative Surgical Procedures Preventing Exercise
Item
past history of clinically significant dysfunction of other organ systems (e.g., known hepatic disease or hepatic transaminase levels greater than 3x the upper limit of the normal range other than steatohepatitis; known renal dysfunction or creatinine level 1.5 mg/dl or greater; past history of malignancies excluding cutaneous basal cell carcinoma; known chronic infections including hiv, endocrinopathies such as untreated thyroid disease, adrenal disease, or pituitary dysfunction, etc.), or any recent surgeries that preclude regular exercise, in the opinion of the investigators
boolean
C0349410 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C1848701 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C2711227 (UMLS CUI [4,2])
C3279454 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0006826 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C0007117 (UMLS CUI [8,2])
C0151317 (UMLS CUI [9])
C0019693 (UMLS CUI [10])
C0014130 (UMLS CUI [11])
C0040128 (UMLS CUI [12,1])
C0332155 (UMLS CUI [12,2])
C0001621 (UMLS CUI [13])
C0281947 (UMLS CUI [14])
C0543467 (UMLS CUI [15,1])
C1292733 (UMLS CUI [15,2])
C0015259 (UMLS CUI [15,3])
Anemia, Hemolytic | Hemoglobinopathies | RBC Turnover Accelerated | Hemoglobin A1c measurement Accuracy altered
Item
active hemolytic anemia, known hemoglobinopathies, or any other state of accelerated rbc turnover that may alter the accuracy of the hba1c measurement
boolean
C0002878 (UMLS CUI [1])
C0019045 (UMLS CUI [2])
C0014792 (UMLS CUI [3,1])
C0243127 (UMLS CUI [3,2])
C0521110 (UMLS CUI [3,3])
C0474680 (UMLS CUI [4,1])
C0443131 (UMLS CUI [4,2])
C0392747 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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