ID

37348

Descripción

Effect of AT-derived miRNA on the Biology and Insulin Sensitivity of Skeletal Muscle in Humans; ODM derived from: https://clinicaltrials.gov/show/NCT02459106

Link

https://clinicaltrials.gov/show/NCT02459106

Palabras clave

Versiones (1)
  1. 19/7/19 19/7/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

19 de julio de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02459106

Inglés

Eligibility Type 2 Diabetes Mellitus NCT02459106

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
able to communicate meaningfully with the investigator and legally competent to provide informed written consent
Descripción

Able to communicate Research Personnel | Legal competency Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0035173
UMLS CUI [2,1]
C0680554
UMLS CUI [2,2]
C0021430
18-65 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
bmi of 20-25 kg/m2 (lean subjects); 30-35 kg/m2 (obese subjects)
Descripción

Body mass index | Study Subject Lean | Study Subject Obese

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0424678
UMLS CUI [3,1]
C0681850
UMLS CUI [3,2]
C0028754
stable body weight (< 3 kg change in the last 8 weeks)
Descripción

Stable body weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0517386
homeostatic model assessment (homa)-insulin resistance <2.7 if lean; homeostatic model assessment (homa)-insulin resistance ≥2.7 if obese
Descripción

Homeostasis model assessment Insulin Resistance Measurement | Study Subject Lean | Study Subject Obese

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1829779
UMLS CUI [1,2]
C4049994
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0424678
UMLS CUI [3,1]
C0681850
UMLS CUI [3,2]
C0028754
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
lactation or pregnancy, current and/or within last 6 months, per participant's report
Descripción

Breast Feeding | Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
female subjects postmenopausal
Descripción

Postmenopausal state

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months)
Descripción

Cardiovascular Disease | Angina, Unstable | Myocardial Infarction | Coronary revascularisation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0877341
liver disease (ast or alt(alanine aminotransferase)>2.5 times the upper limit of normal)
Descripción

Liver disease | Aspartate aminotransferase increased | Alanine aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
kidney disease (creatinine >1.6 mg/dl)
Descripción

Kidney Disease | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0201976
anemia (hemoglobin <12 g/dl in men, <11 g/dl in women)
Descripción

Anemia | Hemoglobin measurement | Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0079399
thyroid dysfunction (abnormal tsh)
Descripción

Thyroid dysfunction | Serum TSH level abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0348024
UMLS CUI [2]
C0580434
hba1c ≥6.5%
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
uncontrolled hypertension (systolic bp>160 mmhg, diastolic bp>100 mmhg)
Descripción

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
history of coagulopathies
Descripción

Blood Coagulation Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005779
history (within the last 5 years) or presence of malignancy, (skin cancers, with the exception of melanoma, may be acceptable)
Descripción

Malignant Neoplasms | Exception Skin carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
current or history of drug abuse or alcohol abuse (>2 drinks/day)
Descripción

Substance Use Disorders | Drinks U/day

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0001967
UMLS CUI [2,2]
C0456683
prior treatment (within last 3 months) with systemic glucocorticoids (>2 weeks), beta-blockers, drugs for weight loss, niacin or fibrates
Descripción

Glucocorticoids, Systemic | Adrenergic beta-1 Receptor Antagonists | Weight-Loss Agents | Niacin | Fibrates

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3540777
UMLS CUI [2]
C0304516
UMLS CUI [3]
C0376606
UMLS CUI [4]
C0027996
UMLS CUI [5]
C1449704
history of hiv, active hepatitis b or c, or tuberculosis (participant reported)
Descripción

HIV Infection | Hepatitis B | Hepatitis C | Tuberculosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0041296
smoke > 5 cigarettes per day
Descripción

Tobacco use Number of cigarettes per day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02459106

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Able to communicate Research Personnel | Legal competency Informed Consent
Item
able to communicate meaningfully with the investigator and legally competent to provide informed written consent
boolean
C2364293 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0680554 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
Age
Item
18-65 years of age
boolean
C0001779 (UMLS CUI [1])
Body mass index | Study Subject Lean | Study Subject Obese
Item
bmi of 20-25 kg/m2 (lean subjects); 30-35 kg/m2 (obese subjects)
boolean
C1305855 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C0424678 (UMLS CUI [2,2])
C0681850 (UMLS CUI [3,1])
C0028754 (UMLS CUI [3,2])
Stable body weight
Item
stable body weight (< 3 kg change in the last 8 weeks)
boolean
C0517386 (UMLS CUI [1])
Homeostasis model assessment Insulin Resistance Measurement | Study Subject Lean | Study Subject Obese
Item
homeostatic model assessment (homa)-insulin resistance <2.7 if lean; homeostatic model assessment (homa)-insulin resistance ≥2.7 if obese
boolean
C1829779 (UMLS CUI [1,1])
C4049994 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C0424678 (UMLS CUI [2,2])
C0681850 (UMLS CUI [3,1])
C0028754 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Breast Feeding | Pregnancy
Item
lactation or pregnancy, current and/or within last 6 months, per participant's report
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Postmenopausal state
Item
female subjects postmenopausal
boolean
C0232970 (UMLS CUI [1])
Cardiovascular Disease | Angina, Unstable | Myocardial Infarction | Coronary revascularisation
Item
cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months)
boolean
C0007222 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0877341 (UMLS CUI [4])
Liver disease | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
liver disease (ast or alt(alanine aminotransferase)>2.5 times the upper limit of normal)
boolean
C0023895 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Kidney Disease | Creatinine measurement, serum
Item
kidney disease (creatinine >1.6 mg/dl)
boolean
C0022658 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Anemia | Hemoglobin measurement | Gender
Item
anemia (hemoglobin <12 g/dl in men, <11 g/dl in women)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Thyroid dysfunction | Serum TSH level abnormal
Item
thyroid dysfunction (abnormal tsh)
boolean
C0348024 (UMLS CUI [1])
C0580434 (UMLS CUI [2])
Hemoglobin A1c measurement
Item
hba1c ≥6.5%
boolean
C0474680 (UMLS CUI [1])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled hypertension (systolic bp>160 mmhg, diastolic bp>100 mmhg)
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Blood Coagulation Disorders
Item
history of coagulopathies
boolean
C0005779 (UMLS CUI [1])
Malignant Neoplasms | Exception Skin carcinoma
Item
history (within the last 5 years) or presence of malignancy, (skin cancers, with the exception of melanoma, may be acceptable)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Substance Use Disorders | Drinks U/day
Item
current or history of drug abuse or alcohol abuse (>2 drinks/day)
boolean
C0038586 (UMLS CUI [1])
C0001967 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Glucocorticoids, Systemic | Adrenergic beta-1 Receptor Antagonists | Weight-Loss Agents | Niacin | Fibrates
Item
prior treatment (within last 3 months) with systemic glucocorticoids (>2 weeks), beta-blockers, drugs for weight loss, niacin or fibrates
boolean
C3540777 (UMLS CUI [1])
C0304516 (UMLS CUI [2])
C0376606 (UMLS CUI [3])
C0027996 (UMLS CUI [4])
C1449704 (UMLS CUI [5])
HIV Infection | Hepatitis B | Hepatitis C | Tuberculosis
Item
history of hiv, active hepatitis b or c, or tuberculosis (participant reported)
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0041296 (UMLS CUI [4])
Tobacco use Number of cigarettes per day
Item
smoke > 5 cigarettes per day
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
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