ID

33195

Beschreibung

Effect of Pioglitazone on Mitochondrial Function in Muscle and Adipose Tissue in Humans; ODM derived from: https://clinicaltrials.gov/show/NCT01165190

Link

https://clinicaltrials.gov/show/NCT01165190

Stichworte

Versionen (1)
  1. 30.11.18 30.11.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

30. November 2018

DOI

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Creative Commons BY 4.0
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Eligibility Type II Diabetes Mellitus NCT01165190

Englisch

Eligibility Type II Diabetes Mellitus NCT01165190

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
Beschreibung

Able to communicate Research Personnel | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0035173
UMLS CUI [2]
C0021430
2. subjects may be of either sex with age as described in each protocol. female subjects must be non-lactating and will be eligible only if they have a negative pregnancy test throughout the study period.
Beschreibung

Age Study Protocol | Gender Breast Feeding Absent | Gender Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0006147
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0427780
3. subjects must range in age from 18-65.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. subjects must have the following laboratory values:
Beschreibung

Laboratory Results

Datentyp

boolean

Alias
UMLS CUI [1]
C1254595
2-hour ogtt plasma glucose 140-250 mg/dl
Beschreibung

Plasma Glucose Measurement OGTT

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0202042
UMLS CUI [1,2]
C0029161
hematocrit ≥ 35 vol%
Beschreibung

Hematocrit level

Datentyp

boolean

Alias
UMLS CUI [1]
C0518014
serum creatinine ≤ 1.6 mg/dl
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
ast (sgot) < 2.5 times upper limit of normal
Beschreibung

Aspartate aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
alt (sgpt) < 2.5 times upper limit of normal
Beschreibung

Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
pt, ptt within the normal range
Beschreibung

Prothrombin time normal | Partial Thromboplastin Time measurement Normal

Datentyp

boolean

Alias
UMLS CUI [1]
C0580551
UMLS CUI [2,1]
C0030605
UMLS CUI [2,2]
C0205307
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects must not be receiving any medications with known effects on glucose tolerance unless the subject has been on stable dose of such agents for the past three months before entry into the study. subjects taking systemic glucocorticoids will be excluded. subjects may be taking a stable dose of estrogens or other hormonal replacement therapy, if the subject has been on these agents for the prior three months.
Beschreibung

Pharmaceutical Preparations Effect Glucose tolerance | Glucocorticoids, Systemic | Estrogens Dose Stable allowed | Hormone replacement therapy Dose Stable allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C0178665
UMLS CUI [2]
C3540777
UMLS CUI [3,1]
C0014939
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [3,4]
C0683607
UMLS CUI [4,1]
C0282402
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
UMLS CUI [4,4]
C0683607
2. history of clinically significant heart disease, including ischemic heart disease (new york heart classification greater than grade ii; more than non-specific st-t wave changes on the ekg) and congestive heart failure
Beschreibung

Heart Disease | Myocardial Ischemia New York Heart Association Classification | Myocardial Ischemia More Than ECG Nonspecific ST-T change | Congestive heart failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0151744
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C0151744
UMLS CUI [3,2]
C0439093
UMLS CUI [3,3]
C1112720
UMLS CUI [4]
C0018802
3. history of peripheral vascular disease (history of claudication)
Beschreibung

Peripheral Vascular Disease | Claudication

Datentyp

boolean

Alias
UMLS CUI [1]
C0085096
UMLS CUI [2]
C1456822
4. history of pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation).
Beschreibung

Lung disease | Dyspnea on exertion | Abnormal breath sounds Auscultation

Datentyp

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0231807
UMLS CUI [3,1]
C0231856
UMLS CUI [3,2]
C0004339
5. history of peripheral edema
Beschreibung

Peripheral edema

Datentyp

boolean

Alias
UMLS CUI [1]
C0085649
6. uncontrolled hypertension with systolic bp>160 mmhg, diastolic bp>100 mmhg
Beschreibung

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
7. resting heart rate >100 beats/min
Beschreibung

Resting heart rate

Datentyp

boolean

Alias
UMLS CUI [1]
C1821417
8. autonomic neuropathy
Beschreibung

Autonomic neuropathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0259749
9. heavy alcohol consumption (> 2 drinks/day)
Beschreibung

Heavy drinker Alcoholic drinks per day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0337678
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0439505
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Ähnliche Modelle

Eligibility Type II Diabetes Mellitus NCT01165190

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Able to communicate Research Personnel | Informed Consent
Item
1. subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
boolean
C2364293 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Age Study Protocol | Gender Breast Feeding Absent | Gender Pregnancy test negative
Item
2. subjects may be of either sex with age as described in each protocol. female subjects must be non-lactating and will be eligible only if they have a negative pregnancy test throughout the study period.
boolean
C0001779 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
Age
Item
3. subjects must range in age from 18-65.
boolean
C0001779 (UMLS CUI [1])
Laboratory Results
Item
4. subjects must have the following laboratory values:
boolean
C1254595 (UMLS CUI [1])
Plasma Glucose Measurement OGTT
Item
2-hour ogtt plasma glucose 140-250 mg/dl
boolean
C0202042 (UMLS CUI [1,1])
C0029161 (UMLS CUI [1,2])
Hematocrit level
Item
hematocrit ≥ 35 vol%
boolean
C0518014 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine ≤ 1.6 mg/dl
boolean
C0201976 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
ast (sgot) < 2.5 times upper limit of normal
boolean
C0201899 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
alt (sgpt) < 2.5 times upper limit of normal
boolean
C0201836 (UMLS CUI [1])
Prothrombin time normal | Partial Thromboplastin Time measurement Normal
Item
pt, ptt within the normal range
boolean
C0580551 (UMLS CUI [1])
C0030605 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Effect Glucose tolerance | Glucocorticoids, Systemic | Estrogens Dose Stable allowed | Hormone replacement therapy Dose Stable allowed
Item
1. subjects must not be receiving any medications with known effects on glucose tolerance unless the subject has been on stable dose of such agents for the past three months before entry into the study. subjects taking systemic glucocorticoids will be excluded. subjects may be taking a stable dose of estrogens or other hormonal replacement therapy, if the subject has been on these agents for the prior three months.
boolean
C0013227 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C0178665 (UMLS CUI [1,3])
C3540777 (UMLS CUI [2])
C0014939 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0683607 (UMLS CUI [3,4])
C0282402 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0683607 (UMLS CUI [4,4])
Heart Disease | Myocardial Ischemia New York Heart Association Classification | Myocardial Ischemia More Than ECG Nonspecific ST-T change | Congestive heart failure
Item
2. history of clinically significant heart disease, including ischemic heart disease (new york heart classification greater than grade ii; more than non-specific st-t wave changes on the ekg) and congestive heart failure
boolean
C0018799 (UMLS CUI [1])
C0151744 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0151744 (UMLS CUI [3,1])
C0439093 (UMLS CUI [3,2])
C1112720 (UMLS CUI [3,3])
C0018802 (UMLS CUI [4])
Peripheral Vascular Disease | Claudication
Item
3. history of peripheral vascular disease (history of claudication)
boolean
C0085096 (UMLS CUI [1])
C1456822 (UMLS CUI [2])
Lung disease | Dyspnea on exertion | Abnormal breath sounds Auscultation
Item
4. history of pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation).
boolean
C0024115 (UMLS CUI [1])
C0231807 (UMLS CUI [2])
C0231856 (UMLS CUI [3,1])
C0004339 (UMLS CUI [3,2])
Peripheral edema
Item
5. history of peripheral edema
boolean
C0085649 (UMLS CUI [1])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
6. uncontrolled hypertension with systolic bp>160 mmhg, diastolic bp>100 mmhg
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Resting heart rate
Item
7. resting heart rate >100 beats/min
boolean
C1821417 (UMLS CUI [1])
Autonomic neuropathy
Item
8. autonomic neuropathy
boolean
C0259749 (UMLS CUI [1])
Heavy drinker Alcoholic drinks per day
Item
9. heavy alcohol consumption (> 2 drinks/day)
boolean
C0337678 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
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