ID

22963

Beskrivning

Moderate Alcohol Intake Among Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00295334

Länk

https://clinicaltrials.gov/show/NCT00295334

Nyckelord

  1. 2017-06-18 2017-06-18 -
Uppladdad den

18 juni 2017

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes NCT00295334

Eligibility Type 2 Diabetes NCT00295334

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age between 40-75 yrs.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. alcohol abstainers (less than or equal to 1 drink/week)
Beskrivning

AOD abstainer

Datatyp

boolean

Alias
UMLS CUI [1]
C0682156
3. established diagnosis of type 2 diabetes.
Beskrivning

Diabetes Mellitus Type 2

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
4. clinically stable, with no stroke or mi within the last 3 months and no major surgery within the last 3 months.
Beskrivning

Stable Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0205360
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. taking insulin >2 injections /day, or with insulin pump.
Beskrivning

Insulin Treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0745343
2. tgs>500 mg/dl.
Beskrivning

Triglycerides

Datatyp

boolean

Alias
UMLS CUI [1]
C0202236
3. hba1c >10%
Beskrivning

HbA1c

Datatyp

boolean

Alias
UMLS CUI [1]
C0019018
4. serum creatinine > 2 mg/dl
Beskrivning

Serum Creatinine

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
5. liver dysfunction (above 2 fold level of alt and/or ast enzymes)
Beskrivning

Liver function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
5. evidence of severe diabetes complications (such as proliferative retinopathy or renal disease).
Beskrivning

Complications of Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0342257
6. patients with autonomic neuropathy manifested as postural hypertension and/or hypoglycemia unawareness.
Beskrivning

Autonomic neuropathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0259749
7. using drugs that might significantly interact with moderate alcohol. list of drugs will be obtained from pharmacology expert.
Beskrivning

Drug interactions

Datatyp

text

Alias
UMLS CUI [1]
C0687133
8. presence of active cancer, receiving or had received chemotherapy in last 3 years.
Beskrivning

Malignant Neoplasms

Datatyp

text

Alias
UMLS CUI [1]
C0006826
9. suffering a major illness that might probably require hospitalization (upon physician's evaluation).
Beskrivning

Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
10. clinically assessed as having high potential of addictive behavior as judged by a validated clinical assessment and/or personal or family history of addiction, alcoholism or alcohol abuse.
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
11. severe symptoms during run-in as assessed by the physician.
Beskrivning

Severe symptoms

Datatyp

boolean

Alias
UMLS CUI [1]
C0436345
12. pregnant or lactating women.
Beskrivning

Gynaecological Status

Datatyp

text

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
13. participation in another trial in which active intervention is being received.
Beskrivning

Subject Participation Status

Datatyp

text

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Type 2 Diabetes NCT00295334

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age between 40-75 yrs.
boolean
C0001779 (UMLS CUI [1])
AOD abstainer
Item
2. alcohol abstainers (less than or equal to 1 drink/week)
boolean
C0682156 (UMLS CUI [1])
Diabetes Mellitus Type 2
Item
3. established diagnosis of type 2 diabetes.
boolean
C0011860 (UMLS CUI [1])
Stable Status
Item
4. clinically stable, with no stroke or mi within the last 3 months and no major surgery within the last 3 months.
boolean
C0205360 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Insulin Treatment
Item
1. taking insulin >2 injections /day, or with insulin pump.
boolean
C0745343 (UMLS CUI [1])
Triglycerides
Item
2. tgs>500 mg/dl.
boolean
C0202236 (UMLS CUI [1])
HbA1c
Item
3. hba1c >10%
boolean
C0019018 (UMLS CUI [1])
Serum Creatinine
Item
4. serum creatinine > 2 mg/dl
boolean
C0201976 (UMLS CUI [1])
Liver function
Item
5. liver dysfunction (above 2 fold level of alt and/or ast enzymes)
boolean
C0232741 (UMLS CUI [1])
Complications of Diabetes Mellitus
Item
5. evidence of severe diabetes complications (such as proliferative retinopathy or renal disease).
boolean
C0342257 (UMLS CUI [1])
Autonomic neuropathy
Item
6. patients with autonomic neuropathy manifested as postural hypertension and/or hypoglycemia unawareness.
boolean
C0259749 (UMLS CUI [1])
Drug interactions
Item
7. using drugs that might significantly interact with moderate alcohol. list of drugs will be obtained from pharmacology expert.
text
C0687133 (UMLS CUI [1])
Malignant Neoplasms
Item
8. presence of active cancer, receiving or had received chemotherapy in last 3 years.
text
C0006826 (UMLS CUI [1])
Comorbidity
Item
9. suffering a major illness that might probably require hospitalization (upon physician's evaluation).
boolean
C0009488 (UMLS CUI [1])
Substance Use Disorders
Item
10. clinically assessed as having high potential of addictive behavior as judged by a validated clinical assessment and/or personal or family history of addiction, alcoholism or alcohol abuse.
boolean
C0038586 (UMLS CUI [1])
Severe symptoms
Item
11. severe symptoms during run-in as assessed by the physician.
boolean
C0436345 (UMLS CUI [1])
Gynaecological Status
Item
12. pregnant or lactating women.
text
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Subject Participation Status
Item
13. participation in another trial in which active intervention is being received.
text
C2348568 (UMLS CUI [1])

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