ID

33078

Description

What Makes Exercise Feel More Difficult to Women With and Without Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00785005

Lien

https://clinicaltrials.gov/show/NCT00785005

Mots-clés

Versions (1)
  1. 26/11/2018 26/11/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

26 novembre 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00785005

Anglais

Eligibility Type 2 Diabetes NCT00785005

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
sedentary women not participating in a regular exercise program (> one bout of exercise per week)
Description

Gender | Sedentary lifestyle | Exercise Regular Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C1532253
UMLS CUI [3,1]
C0015259
UMLS CUI [3,2]
C0205272
UMLS CUI [3,3]
C0332197
if subject has diabetes, must be uncomplicated t2dm and < 25 years since t2dm diagnosis
Description

Non-Insulin-Dependent Diabetes Mellitus Uncomplicated Disease length

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0443334
UMLS CUI [1,3]
C0872146
ages of 50-70 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
bmi of 25-35
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
subjects can only be taking the following oral hypoglycemic drugs: metformin, sulfonylureas or sitagliptin. use of insulin or other oral hypoglycemic medications is not allowed.
Description

Oral hypoglycemic | Metformin | Sulfonylureas | sitagliptin | Insulin Excluded

Type de données

boolean

Alias
UMLS CUI [1]
C0359086
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0038766
UMLS CUI [4]
C1565750
UMLS CUI [5,1]
C0021641
UMLS CUI [5,2]
C0332196
persons with t2dm will be accepted for study only if they have total glycosylated hemoglobin levels (hba1c) <8% (adequate control) on therapy.
Description

Non-Insulin-Dependent Diabetes Mellitus Controlled | Hemoglobin A1c measurement

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C2911690
UMLS CUI [2]
C0474680
control subjects must have hba1c < 5.5% and a fasting blood glucose of <100 mg/dl suggesting no significant insulin resistance.
Description

Control Group | Hemoglobin A1c measurement | Fasting blood glucose measurement | Insulin Resistance Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0009932
UMLS CUI [2]
C0474680
UMLS CUI [3]
C0428568
UMLS CUI [4,1]
C0021655
UMLS CUI [4,2]
C0332197
all women must be post-menopausal, documented by menstrual history and follicle stimulating hormone (fsh) level.
Description

Postmenopausal state | Menstrual History | Follicle stimulating hormone measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C1954761
UMLS CUI [3]
C0202022
current smokers will be excluded since smoking can impair cv exercise performance but people who have quit smoking for at least 1 year will be accepted for study.
Description

Tobacco use Excluded | Tobacco use Impairing Exercise | Cessation of smoking Accepted

Type de données

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0332196
UMLS CUI [2,1]
C0543414
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0015259
UMLS CUI [3,1]
C0085134
UMLS CUI [3,2]
C1272684
absence of comorbid conditions will be confirmed by history, physical examination and laboratory testing.
Description

Comorbidity Absent Medical History | Comorbidity Absent Physical Examination | Comorbidity Absent Laboratory Procedures

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0031809
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0022885
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
in general, people will be excluded with any condition which could limit exercise performance.
Description

Condition Limiting Exercise

Type de données

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0015259
persons with clinically evident distal symmetrical neuropathy, determined by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, light touch, ankle jerks), will be excluded from further study as neuropathy may limit exercise performance.
Description

Neuropathy Distal Symmetrical | Symptom Evaluation | Numbness | Paresthesia | Evaluation Signs | Vibration test | Sensation pinprick test | Light touch | Ankle reflex | Neuropathy Limiting Exercise

Type de données

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0205108
UMLS CUI [1,3]
C0332516
UMLS CUI [2]
C3494438
UMLS CUI [3]
C0028643
UMLS CUI [4]
C0030554
UMLS CUI [5,1]
C1261322
UMLS CUI [5,2]
C0311392
UMLS CUI [6]
C1142180
UMLS CUI [7]
C4479969
UMLS CUI [8]
C0576660
UMLS CUI [9]
C0234171
UMLS CUI [10,1]
C0442874
UMLS CUI [10,2]
C0439801
UMLS CUI [10,3]
C0015259
persons with autonomic dysfunction (>20 mm fall in upright bp without a change in heart rate) will be excluded as well, due to associated limitations of exercise performance.
Description

Autonomic dysfunction Limiting Exercise | Blood pressure orthostatic decreased

Type de données

boolean

Alias
UMLS CUI [1,1]
C1145628
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0015259
UMLS CUI [2]
C1095974
persons will be excluded if they have evidence of heart disease by history (prior heart attack or bypass surgery, heart failure, or significant valvular disease) or abnormal resting electrocardiogram (ekg) consistent with prior infarct or latent ischemia (unless cardiovascular stress imaging or catheterization shows they do not have coronary artery disease). we will also exclude subjects with left or right bundle branch block on resting ekg (precludes recognition of ischemic ekg changes with exercise) or abnormal exercise ekg (> 1 mm st segment depression 80 msec out in the st segment for 3 consecutive beats).
Description

Heart Disease | Myocardial Infarction | Bypass surgery | Heart failure | Valvular disease | Electrocardiogram abnormal At rest | Infarction | Ischemia Latent | Exception Coronary Artery Disease Absent | Electrocardiogram: left bundle branch block At rest | Electrocardiogram: right bundle branch block At rest | Exercise ECG abnormal ST segment depression

Type de données

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0027051
UMLS CUI [3]
C1536078
UMLS CUI [4]
C0018801
UMLS CUI [5]
C3258293
UMLS CUI [6,1]
C0522055
UMLS CUI [6,2]
C0443144
UMLS CUI [7]
C0021308
UMLS CUI [8,1]
C0022116
UMLS CUI [8,2]
C0205275
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C1956346
UMLS CUI [9,3]
C0332197
UMLS CUI [10,1]
C0344420
UMLS CUI [10,2]
C0443144
UMLS CUI [11,1]
C0344421
UMLS CUI [11,2]
C0443144
UMLS CUI [12,1]
C0149612
UMLS CUI [12,2]
C0520887
persons with angina or any other exercise-limiting cardiovascular, pulmonary or musculoskeletal symptoms will be excluded as well.
Description

Angina Pectoris | Cardiovascular symptoms Limiting Exercise | Symptoms Pulmonary Limiting Exercise | Musculoskeletal symptom Limiting Exercise

Type de données

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2,1]
C0476270
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0015259
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C2709248
UMLS CUI [3,3]
C0439801
UMLS CUI [3,4]
C0015259
UMLS CUI [4,1]
C0231443
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0015259
presence of systolic blood pressure >150 at rest or >250 with exercise or diastolic pressure >95 at rest or >105 with exercise are also grounds for exclusion.
Description

Systolic blood pressure at rest | Systolic Pressure Exercise | Diastolic blood pressure at rest | Diastolic blood pressure Exercise

Type de données

boolean

Alias
UMLS CUI [1]
C2039694
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0015259
UMLS CUI [3]
C2183311
UMLS CUI [4,1]
C0428883
UMLS CUI [4,2]
C0015259
subjects with proteinuria (urine protein >200 mg/dl) or a creatinine > 2 mg/dl, suggestive of renal disease will be excluded.
Description

Proteinuria | Urine protein test | Serum creatinine measurement Suggestive of Kidney Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0033687
UMLS CUI [2]
C0262923
UMLS CUI [3,1]
C0201976
UMLS CUI [3,2]
C0332299
UMLS CUI [3,3]
C0022658
subjects with total cholesterol >220 mg/dl, low density lipoprotein > 130 mg/dl, or triglycerides > 250 mg/dl will be excluded given the potential insulin resistance and endothelial dysfunction associated with these cholesterol parameters.
Description

Serum total cholesterol measurement | Low density lipoprotein measurement | Triglycerides measurement | Insulin Resistance potential | Endothelial dysfunction potential

Type de données

boolean

Alias
UMLS CUI [1]
C1445957
UMLS CUI [2]
C0202116
UMLS CUI [3]
C0202236
UMLS CUI [4,1]
C0021655
UMLS CUI [4,2]
C3245505
UMLS CUI [5,1]
C0856169
UMLS CUI [5,2]
C3245505
subjects taking the following medications will be excluded: insulin, oral hypoglycemic agents other than those stated in inclusion criteria, estrogen-containing hormone replacement therapy including the "estring".
Description

Insulin | Oral hypoglycemic | Hormone replacement therapy Containing Estrogens | Estring

Type de données

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0359086
UMLS CUI [3,1]
C0282402
UMLS CUI [3,2]
C0332256
UMLS CUI [3,3]
C0014939
UMLS CUI [4]
C0591465
control subjects who have an immediate family member with type 2 diabetes will be excluded.
Description

Control Group | Family member Non-Insulin-Dependent Diabetes Mellitus

Type de données

boolean

Alias
UMLS CUI [1]
C0009932
UMLS CUI [2,1]
C0086282
UMLS CUI [2,2]
C0011860
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Similar models

Eligibility Type 2 Diabetes NCT00785005

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Sedentary lifestyle | Exercise Regular Absent
Item
sedentary women not participating in a regular exercise program (> one bout of exercise per week)
boolean
C0079399 (UMLS CUI [1])
C1532253 (UMLS CUI [2])
C0015259 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Non-Insulin-Dependent Diabetes Mellitus Uncomplicated Disease length
Item
if subject has diabetes, must be uncomplicated t2dm and < 25 years since t2dm diagnosis
boolean
C0011860 (UMLS CUI [1,1])
C0443334 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,3])
Age
Item
ages of 50-70 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
bmi of 25-35
boolean
C1305855 (UMLS CUI [1])
Oral hypoglycemic | Metformin | Sulfonylureas | sitagliptin | Insulin Excluded
Item
subjects can only be taking the following oral hypoglycemic drugs: metformin, sulfonylureas or sitagliptin. use of insulin or other oral hypoglycemic medications is not allowed.
boolean
C0359086 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C0038766 (UMLS CUI [3])
C1565750 (UMLS CUI [4])
C0021641 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
Non-Insulin-Dependent Diabetes Mellitus Controlled | Hemoglobin A1c measurement
Item
persons with t2dm will be accepted for study only if they have total glycosylated hemoglobin levels (hba1c) <8% (adequate control) on therapy.
boolean
C0011860 (UMLS CUI [1,1])
C2911690 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
Control Group | Hemoglobin A1c measurement | Fasting blood glucose measurement | Insulin Resistance Absent
Item
control subjects must have hba1c < 5.5% and a fasting blood glucose of <100 mg/dl suggesting no significant insulin resistance.
boolean
C0009932 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0428568 (UMLS CUI [3])
C0021655 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Postmenopausal state | Menstrual History | Follicle stimulating hormone measurement
Item
all women must be post-menopausal, documented by menstrual history and follicle stimulating hormone (fsh) level.
boolean
C0232970 (UMLS CUI [1])
C1954761 (UMLS CUI [2])
C0202022 (UMLS CUI [3])
Tobacco use Excluded | Tobacco use Impairing Exercise | Cessation of smoking Accepted
Item
current smokers will be excluded since smoking can impair cv exercise performance but people who have quit smoking for at least 1 year will be accepted for study.
boolean
C0543414 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0543414 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0015259 (UMLS CUI [2,3])
C0085134 (UMLS CUI [3,1])
C1272684 (UMLS CUI [3,2])
Comorbidity Absent Medical History | Comorbidity Absent Physical Examination | Comorbidity Absent Laboratory Procedures
Item
absence of comorbid conditions will be confirmed by history, physical examination and laboratory testing.
boolean
C0009488 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0031809 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0022885 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Condition Limiting Exercise
Item
in general, people will be excluded with any condition which could limit exercise performance.
boolean
C0348080 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
Neuropathy Distal Symmetrical | Symptom Evaluation | Numbness | Paresthesia | Evaluation Signs | Vibration test | Sensation pinprick test | Light touch | Ankle reflex | Neuropathy Limiting Exercise
Item
persons with clinically evident distal symmetrical neuropathy, determined by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, light touch, ankle jerks), will be excluded from further study as neuropathy may limit exercise performance.
boolean
C0442874 (UMLS CUI [1,1])
C0205108 (UMLS CUI [1,2])
C0332516 (UMLS CUI [1,3])
C3494438 (UMLS CUI [2])
C0028643 (UMLS CUI [3])
C0030554 (UMLS CUI [4])
C1261322 (UMLS CUI [5,1])
C0311392 (UMLS CUI [5,2])
C1142180 (UMLS CUI [6])
C4479969 (UMLS CUI [7])
C0576660 (UMLS CUI [8])
C0234171 (UMLS CUI [9])
C0442874 (UMLS CUI [10,1])
C0439801 (UMLS CUI [10,2])
C0015259 (UMLS CUI [10,3])
Autonomic dysfunction Limiting Exercise | Blood pressure orthostatic decreased
Item
persons with autonomic dysfunction (>20 mm fall in upright bp without a change in heart rate) will be excluded as well, due to associated limitations of exercise performance.
boolean
C1145628 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
C1095974 (UMLS CUI [2])
Heart Disease | Myocardial Infarction | Bypass surgery | Heart failure | Valvular disease | Electrocardiogram abnormal At rest | Infarction | Ischemia Latent | Exception Coronary Artery Disease Absent | Electrocardiogram: left bundle branch block At rest | Electrocardiogram: right bundle branch block At rest | Exercise ECG abnormal ST segment depression
Item
persons will be excluded if they have evidence of heart disease by history (prior heart attack or bypass surgery, heart failure, or significant valvular disease) or abnormal resting electrocardiogram (ekg) consistent with prior infarct or latent ischemia (unless cardiovascular stress imaging or catheterization shows they do not have coronary artery disease). we will also exclude subjects with left or right bundle branch block on resting ekg (precludes recognition of ischemic ekg changes with exercise) or abnormal exercise ekg (> 1 mm st segment depression 80 msec out in the st segment for 3 consecutive beats).
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C1536078 (UMLS CUI [3])
C0018801 (UMLS CUI [4])
C3258293 (UMLS CUI [5])
C0522055 (UMLS CUI [6,1])
C0443144 (UMLS CUI [6,2])
C0021308 (UMLS CUI [7])
C0022116 (UMLS CUI [8,1])
C0205275 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C1956346 (UMLS CUI [9,2])
C0332197 (UMLS CUI [9,3])
C0344420 (UMLS CUI [10,1])
C0443144 (UMLS CUI [10,2])
C0344421 (UMLS CUI [11,1])
C0443144 (UMLS CUI [11,2])
C0149612 (UMLS CUI [12,1])
C0520887 (UMLS CUI [12,2])
Angina Pectoris | Cardiovascular symptoms Limiting Exercise | Symptoms Pulmonary Limiting Exercise | Musculoskeletal symptom Limiting Exercise
Item
persons with angina or any other exercise-limiting cardiovascular, pulmonary or musculoskeletal symptoms will be excluded as well.
boolean
C0002962 (UMLS CUI [1])
C0476270 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0015259 (UMLS CUI [2,3])
C1457887 (UMLS CUI [3,1])
C2709248 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0015259 (UMLS CUI [3,4])
C0231443 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0015259 (UMLS CUI [4,3])
Systolic blood pressure at rest | Systolic Pressure Exercise | Diastolic blood pressure at rest | Diastolic blood pressure Exercise
Item
presence of systolic blood pressure >150 at rest or >250 with exercise or diastolic pressure >95 at rest or >105 with exercise are also grounds for exclusion.
boolean
C2039694 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
C2183311 (UMLS CUI [3])
C0428883 (UMLS CUI [4,1])
C0015259 (UMLS CUI [4,2])
Proteinuria | Urine protein test | Serum creatinine measurement Suggestive of Kidney Disease
Item
subjects with proteinuria (urine protein >200 mg/dl) or a creatinine > 2 mg/dl, suggestive of renal disease will be excluded.
boolean
C0033687 (UMLS CUI [1])
C0262923 (UMLS CUI [2])
C0201976 (UMLS CUI [3,1])
C0332299 (UMLS CUI [3,2])
C0022658 (UMLS CUI [3,3])
Serum total cholesterol measurement | Low density lipoprotein measurement | Triglycerides measurement | Insulin Resistance potential | Endothelial dysfunction potential
Item
subjects with total cholesterol >220 mg/dl, low density lipoprotein > 130 mg/dl, or triglycerides > 250 mg/dl will be excluded given the potential insulin resistance and endothelial dysfunction associated with these cholesterol parameters.
boolean
C1445957 (UMLS CUI [1])
C0202116 (UMLS CUI [2])
C0202236 (UMLS CUI [3])
C0021655 (UMLS CUI [4,1])
C3245505 (UMLS CUI [4,2])
C0856169 (UMLS CUI [5,1])
C3245505 (UMLS CUI [5,2])
Insulin | Oral hypoglycemic | Hormone replacement therapy Containing Estrogens | Estring
Item
subjects taking the following medications will be excluded: insulin, oral hypoglycemic agents other than those stated in inclusion criteria, estrogen-containing hormone replacement therapy including the "estring".
boolean
C0021641 (UMLS CUI [1])
C0359086 (UMLS CUI [2])
C0282402 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0014939 (UMLS CUI [3,3])
C0591465 (UMLS CUI [4])
Control Group | Family member Non-Insulin-Dependent Diabetes Mellitus
Item
control subjects who have an immediate family member with type 2 diabetes will be excluded.
boolean
C0009932 (UMLS CUI [1])
C0086282 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
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