ID

35786

Description

Effect of Metformin and Cholecystokinin-mediated Gallbladder Emptying on GLP-1 Secretion in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02497313

Link

https://clinicaltrials.gov/show/NCT02497313

Keywords

Versions (1)
  1. 3/22/19 3/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02497313

English

Eligibility Diabetes Mellitus, Type 2 NCT02497313

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes for at least 3 months (diagnosed according to the criteria of the world health organization (who))
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
men and postmenopausal women
Description

Gender | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
metformin applied as the only anti-diabetic drug
Description

Metformin | Antidiabetics

Data type

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0935929
caucasian ethnicity
Description

Caucasians

Data type

boolean

Alias
UMLS CUI [1]
C0043157
normal haemoglobin
Description

Hemoglobin normal

Data type

boolean

Alias
UMLS CUI [1]
C0474529
bmi >23 kg/m2 and <35 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
informed and written consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
liver disease (alanine aminotransferase (alat) and/or serum aspartate aminotransferase (asat) >2 times normal values) or history of hepatobiliary disorder
Description

Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased | Hepatobiliary disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0267792
gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
Description

Gastrointestinal Disease | Intestinal resection | Cholecystectomy procedure | Operation on abdominal region Major

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C1096244
UMLS CUI [3]
C0008320
UMLS CUI [4,1]
C0198482
UMLS CUI [4,2]
C0205164
nephropathy (serum creatinine >150 µm and/or albuminuria)
Description

Kidney Disease | Creatinine measurement, serum | Albuminuria

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0001925
hypo- and hyperthyroidism
Description

Hypothyroidism | Hyperthyroidism

Data type

boolean

Alias
UMLS CUI [1]
C0020676
UMLS CUI [2]
C0020550
hypo- and hypercalcaemia
Description

Hypocalcemia | Hypercalcemia

Data type

boolean

Alias
UMLS CUI [1]
C0020598
UMLS CUI [2]
C0020437
hypo- and hyperphosphataemia
Description

Hypophosphatemia | Hyperphosphatemia

Data type

boolean

Alias
UMLS CUI [1]
C0085682
UMLS CUI [2]
C0085681
active or recent malignant disease
Description

Malignant disease

Data type

boolean

Alias
UMLS CUI [1]
C0442867
treatment with medicine that cannot be paused for 12 hours
Description

Pharmaceutical Preparations Discontinue Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1272705
treatment with oral anticoagulants
Description

Oral anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0354604
any treatment or condition requiring acute or sub-acute medical or surgical intervention
Description

Therapeutic procedure Requirement Intervention | Condition Requirement Intervention | Therapeutic procedure Requirement Surgical intervention | Condition Requirement Surgical intervention | Therapeutic procedure Requirement Intervention Subacute | Condition Requirement Intervention Subacute | Therapeutic procedure Requirement Surgical intervention Subacute | Condition Requirement Surgical intervention Subacute

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0184661
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0184661
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0549433
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0549433
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0184661
UMLS CUI [5,4]
C0205365
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C0184661
UMLS CUI [6,4]
C0205365
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C1514873
UMLS CUI [7,3]
C0549433
UMLS CUI [7,4]
C0205365
UMLS CUI [8,1]
C0348080
UMLS CUI [8,2]
C1514873
UMLS CUI [8,3]
C0549433
UMLS CUI [8,4]
C0205365
any condition considered incompatible with participation by the investigators
Description

Condition Inappropriate Participation

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0679823
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02497313

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes for at least 3 months (diagnosed according to the criteria of the world health organization (who))
boolean
C0011860 (UMLS CUI [1])
Gender | Postmenopausal state
Item
men and postmenopausal women
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Metformin | Antidiabetics
Item
metformin applied as the only anti-diabetic drug
boolean
C0025598 (UMLS CUI [1])
C0935929 (UMLS CUI [2])
Caucasians
Item
caucasian ethnicity
boolean
C0043157 (UMLS CUI [1])
Hemoglobin normal
Item
normal haemoglobin
boolean
C0474529 (UMLS CUI [1])
Body mass index
Item
bmi >23 kg/m2 and <35 kg/m2
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
informed and written consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased | Hepatobiliary disease
Item
liver disease (alanine aminotransferase (alat) and/or serum aspartate aminotransferase (asat) >2 times normal values) or history of hepatobiliary disorder
boolean
C0023895 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0267792 (UMLS CUI [4])
Gastrointestinal Disease | Intestinal resection | Cholecystectomy procedure | Operation on abdominal region Major
Item
gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
boolean
C0017178 (UMLS CUI [1])
C1096244 (UMLS CUI [2])
C0008320 (UMLS CUI [3])
C0198482 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
Kidney Disease | Creatinine measurement, serum | Albuminuria
Item
nephropathy (serum creatinine >150 µm and/or albuminuria)
boolean
C0022658 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0001925 (UMLS CUI [3])
Hypothyroidism | Hyperthyroidism
Item
hypo- and hyperthyroidism
boolean
C0020676 (UMLS CUI [1])
C0020550 (UMLS CUI [2])
Hypocalcemia | Hypercalcemia
Item
hypo- and hypercalcaemia
boolean
C0020598 (UMLS CUI [1])
C0020437 (UMLS CUI [2])
Hypophosphatemia | Hyperphosphatemia
Item
hypo- and hyperphosphataemia
boolean
C0085682 (UMLS CUI [1])
C0085681 (UMLS CUI [2])
Malignant disease
Item
active or recent malignant disease
boolean
C0442867 (UMLS CUI [1])
Pharmaceutical Preparations Discontinue Unsuccessful
Item
treatment with medicine that cannot be paused for 12 hours
boolean
C0013227 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
Oral anticoagulants
Item
treatment with oral anticoagulants
boolean
C0354604 (UMLS CUI [1])
Therapeutic procedure Requirement Intervention | Condition Requirement Intervention | Therapeutic procedure Requirement Surgical intervention | Condition Requirement Surgical intervention | Therapeutic procedure Requirement Intervention Subacute | Condition Requirement Intervention Subacute | Therapeutic procedure Requirement Surgical intervention Subacute | Condition Requirement Surgical intervention Subacute
Item
any treatment or condition requiring acute or sub-acute medical or surgical intervention
boolean
C0087111 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0549433 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0549433 (UMLS CUI [4,3])
C0087111 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0184661 (UMLS CUI [5,3])
C0205365 (UMLS CUI [5,4])
C0348080 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0184661 (UMLS CUI [6,3])
C0205365 (UMLS CUI [6,4])
C0087111 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C0549433 (UMLS CUI [7,3])
C0205365 (UMLS CUI [7,4])
C0348080 (UMLS CUI [8,1])
C1514873 (UMLS CUI [8,2])
C0549433 (UMLS CUI [8,3])
C0205365 (UMLS CUI [8,4])
Condition Inappropriate Participation
Item
any condition considered incompatible with participation by the investigators
boolean
C0348080 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,3])
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