ID

22963

Description

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

Lien

https://clinicaltrials.gov/show/NCT00295334

Mots-clés

  1. 18/06/2017 18/06/2017 -
Téléchargé le

18 juin 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes NCT00295334

Eligibility Type 2 Diabetes NCT00295334

Inclusion Criteria
Description

Inclusion Criteria

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

Age

Type de données

boolean

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

AOD abstainer

Type de données

boolean

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

Diabetes Mellitus Type 2

Type de données

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.
Description

Stable Status

Type de données

boolean

Alias
UMLS CUI [1]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

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

Insulin Treatment

Type de données

boolean

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

Triglycerides

Type de données

boolean

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

HbA1c

Type de données

boolean

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

Serum Creatinine

Type de données

boolean

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

Liver function

Type de données

boolean

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

Complications of Diabetes Mellitus

Type de données

boolean

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

Autonomic neuropathy

Type de données

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.
Description

Drug interactions

Type de données

text

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

Malignant Neoplasms

Type de données

text

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

Comorbidity

Type de données

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.
Description

Substance Use Disorders

Type de données

boolean

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

Severe symptoms

Type de données

boolean

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

Gynaecological Status

Type de données

text

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

Subject Participation Status

Type de données

text

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Type 2 Diabetes NCT00295334

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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