ID

39594

Descripción

The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Pregnancy-induced Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01795248

Link

https://clinicaltrials.gov/show/NCT01795248

Palabras clave

Versiones (1)
  1. 1/2/20 1/2/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

1 de febrero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Gestational Diabetes Mellitus NCT01795248

Inglés

Eligibility Gestational Diabetes Mellitus NCT01795248

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed oral and written consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
previous diagnosis of gdm according to current danish guidelines (mainly pg concentrationa t 120 min after 75 g ogtt ≥ 9.0 mm) during pregnancy within the last 5 years
Descripción

Gestational Diabetes | Plasma Glucose Measurement | Oral Glucose Tolerance Test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085207
UMLS CUI [2]
C0202042
UMLS CUI [3]
C0029161
age >18 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
25 kg/m2 < bmi < 45 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
ngt, ifg and or igt
Descripción

Glucose tolerance test normal | Impaired fasting glucose | Impaired glucose tolerance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438251
UMLS CUI [2]
C1272092
UMLS CUI [3]
C0151671
safe contraception and negative pregnancy test
Descripción

Contraceptive methods | Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0427780
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with diabetes
Descripción

Diabetes Mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011849
hba1c ≥6.5%
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
patients with previous pancreatitis or previous neoplasia
Descripción

Pancreatitis Previous | Neoplastic disease Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030305
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1882062
UMLS CUI [2,2]
C0205156
pregnant or breast feeding women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
anaemia (haemoglobin <7 mm)
Descripción

Anemia | Hemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
women planning to become pregnant within the next 5 years
Descripción

Pregnancy, Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032992
women using other contraception than intrauterine device (iud) or oral contraceptives. women who do not use safe contraception will be offered application of an iud.
Descripción

Gender | Contraceptive methods Except Intrauterine Devices | Contraceptive methods Except Oral Contraceptives

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0021900
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0332300
UMLS CUI [3,3]
C0009905
women treated with statins, corticosteroids or other hormone therapy (except estrogens and gestagens)
Descripción

Statins | Adrenal Cortex Hormones | Hormone Therapy | Exception Estrogens | Exception Progestins

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0360714
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0279025
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0014939
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0033306
ongoing abuse of alcohol or narcotics
Descripción

Alcohol abuse | Narcotic Abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0524661
impaired hepatic function (liver transaminases >3 times upper normal limit)
Descripción

Liver Dysfunction | Increased liver transaminases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C4478596
impaired renal function (se-creatinine >120 μm and/or albuminuria)
Descripción

Renal Insufficiency | Creatinine measurement, serum | Albuminuria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0001925
uncontrolled hypertension (systolic blood pressure >180 mmhg, diastolic blood pressure >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
any condition that the investigator feels would interfere with trial participation
Descripción

Condition Interferes with Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
receiving any investigational drug within the last 3 months
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Gestational Diabetes Mellitus NCT01795248

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed oral and written consent
boolean
C0021430 (UMLS CUI [1])
Gestational Diabetes | Plasma Glucose Measurement | Oral Glucose Tolerance Test
Item
previous diagnosis of gdm according to current danish guidelines (mainly pg concentrationa t 120 min after 75 g ogtt ≥ 9.0 mm) during pregnancy within the last 5 years
boolean
C0085207 (UMLS CUI [1])
C0202042 (UMLS CUI [2])
C0029161 (UMLS CUI [3])
Age
Item
age >18 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
25 kg/m2 < bmi < 45 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glucose tolerance test normal | Impaired fasting glucose | Impaired glucose tolerance
Item
ngt, ifg and or igt
boolean
C0438251 (UMLS CUI [1])
C1272092 (UMLS CUI [2])
C0151671 (UMLS CUI [3])
Contraceptive methods | Pregnancy test negative
Item
safe contraception and negative pregnancy test
boolean
C0700589 (UMLS CUI [1])
C0427780 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus
Item
patients with diabetes
boolean
C0011849 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c ≥6.5%
boolean
C0474680 (UMLS CUI [1])
Pancreatitis Previous | Neoplastic disease Previous
Item
patients with previous pancreatitis or previous neoplasia
boolean
C0030305 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1882062 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Anemia | Hemoglobin measurement
Item
anaemia (haemoglobin <7 mm)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Pregnancy, Planned
Item
women planning to become pregnant within the next 5 years
boolean
C0032992 (UMLS CUI [1])
Gender | Contraceptive methods Except Intrauterine Devices | Contraceptive methods Except Oral Contraceptives
Item
women using other contraception than intrauterine device (iud) or oral contraceptives. women who do not use safe contraception will be offered application of an iud.
boolean
C0079399 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0021900 (UMLS CUI [2,3])
C0700589 (UMLS CUI [3,1])
C0332300 (UMLS CUI [3,2])
C0009905 (UMLS CUI [3,3])
Statins | Adrenal Cortex Hormones | Hormone Therapy | Exception Estrogens | Exception Progestins
Item
women treated with statins, corticosteroids or other hormone therapy (except estrogens and gestagens)
boolean
C0360714 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0014939 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0033306 (UMLS CUI [5,2])
Alcohol abuse | Narcotic Abuse
Item
ongoing abuse of alcohol or narcotics
boolean
C0085762 (UMLS CUI [1])
C0524661 (UMLS CUI [2])
Liver Dysfunction | Increased liver transaminases
Item
impaired hepatic function (liver transaminases >3 times upper normal limit)
boolean
C0086565 (UMLS CUI [1])
C4478596 (UMLS CUI [2])
Renal Insufficiency | Creatinine measurement, serum | Albuminuria
Item
impaired renal function (se-creatinine >120 μm and/or albuminuria)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0001925 (UMLS CUI [3])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled hypertension (systolic blood pressure >180 mmhg, diastolic blood pressure >100 mmhg)
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Condition Interferes with Study Subject Participation Status
Item
any condition that the investigator feels would interfere with trial participation
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Investigational New Drugs
Item
receiving any investigational drug within the last 3 months
boolean
C0013230 (UMLS CUI [1])
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