ID

16138

Description

Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02274740

Link

https://clinicaltrials.gov/show/NCT02274740

Keywords

Versions (2)
  1. 7/1/16 7/1/16 -
  2. 7/1/16 7/1/16 -
Uploaded on

July 1, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Type II Diabetes Mellitus NCT02274740

English

Eligibility Type II Diabetes Mellitus NCT02274740

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female patients, 18-70 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of type 2 diabetes treated with metformin and obesity (body mass index [bmi] >30 kg/m^2) and the following other abnormalities:
Description

Therapeutic procedure Diabetes Mellitus, Non-Insulin-Dependent | Metformin | Obesity | Body mass index | Abnormality Following

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0011860
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0028754
UMLS CUI [4]
C1305855
UMLS CUI [5,1]
C1704258
UMLS CUI [5,2]
C0332282
abdominal obesity (waist circumference >102 cm in men and >88 cm in women). according to national cholesterol education program-adult treatment panel (ncep-atp) iii (2001).
Description

Obesity, Abdominal | Waist Circumference | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0311277
UMLS CUI [2]
C0455829
UMLS CUI [3]
C0079399
glycated hemoglobin a1c (hba1c) ≥7 and ≤8.5% (after sponsor approval providers might reasonably suggest more stringent a1c goals [such as 6.5%] for selected individual patients, if this can be achieved without significant hypoglycemia or other adverse effects of treatment. appropriate patients might include those with short duration of diabetes, long life expectancy, and no significant cardiovascular disease).
Description

Glycosylated hemoglobin A | Hypoglycemia Significant | Adverse effects Due to Therapeutic procedure | Diabetes Mellitus Short duration | Life Expectancy Long | Cardiovascular Disease Significant Absent

Data type

boolean

Alias
UMLS CUI [1]
C0019018
UMLS CUI [2,1]
C0020615
UMLS CUI [2,2]
C0750502
UMLS CUI [3,1]
C0879626
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0087111
UMLS CUI [4,1]
C0011849
UMLS CUI [4,2]
C0439593
UMLS CUI [5,1]
C0023671
UMLS CUI [5,2]
C0205166
UMLS CUI [6,1]
C0007222
UMLS CUI [6,2]
C0750502
UMLS CUI [6,3]
C0332197
hypertriglyceridemia (fasting triglyceride levels between 150 mg/dl and 600 mg/dl, cholesterol <300 mg/dl. in order to exclude patients who might be suffering from a primitive dyslipidemia).
Description

Hypertriglyceridemia | Serum fasting triglyceride measurement | Serum total cholesterol measurement | Dyslipidemias Primitive

Data type

boolean

Alias
UMLS CUI [1]
C0020557
UMLS CUI [2]
C0582824
UMLS CUI [3]
C1445957
UMLS CUI [4,1]
C0242339
UMLS CUI [4,2]
C3645627
low high-density lipoprotein (hdl) cholesterol (serum hdl-cholesterol <40 mg/dl in men and <50 mg/dl in women).
Description

Decreased HDL cholesterol | Serum HDL cholesterol measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0151691
UMLS CUI [2]
C0428472
UMLS CUI [3]
C0079399
written informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
smoking. thyroid disease even if under appropriate hormonal replacement therapy or thyroid suppressant (thyroid stimulating hormone [tsh] >5 mu/l with clinical symptoms of hypothyroidism).
Description

Smoking | Thyroid Diseases | Hormone replacement therapy | Antithyroid Agents | Thyroid stimulating hormone measurement | Hypothyroidism Symptoms Clinical

Data type

boolean

Alias
UMLS CUI [1]
C0037369
UMLS CUI [2]
C0040128
UMLS CUI [3]
C0282402
UMLS CUI [4]
C0040125
UMLS CUI [5]
C0202230
UMLS CUI [6,1]
C0020676
UMLS CUI [6,2]
C1457887
UMLS CUI [6,3]
C0205210
hepatic disease (aspartate aminotransferase [asat] or alanine aminotransferase [alat] >2 times the upper limit of normal).
Description

Liver diseases | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
renal disease (serum creatinine >1.7 times the upper limit of normal). a history of coronary heart disease, cerebrovascular disease, or peripheral arterial disease in the 6 months before enrollment.
Description

Kidney Diseases | Creatinine measurement, serum | Coronary heart disease | Cerebrovascular Disorders | Peripheral Arterial Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0010068
UMLS CUI [4]
C0007820
UMLS CUI [5]
C1704436
history of malignancies. use of lipid lowering therapy. systolic blood pressure ≥180 mmhg and/or diastolic blood pressure ≥110 mmhg. triglycerides >600 mg/dl. history of chronic pancreatitis or of idiopathic acute pancreatitis.
Description

Malignant Neoplasms | Lipid-lowering therapy | Systolic Pressure | Diastolic blood pressure | Triglycerides measurement | Pancreatitis, Chronic | Idiopathic acute pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0585943
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
UMLS CUI [5]
C0202236
UMLS CUI [6]
C0149521
UMLS CUI [7]
C0341461
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Type II Diabetes Mellitus NCT02274740

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female patients, 18-70 years of age.
boolean
C0001779 (UMLS CUI [1])
Therapeutic procedure Diabetes Mellitus, Non-Insulin-Dependent | Metformin | Obesity | Body mass index | Abnormality Following
Item
diagnosis of type 2 diabetes treated with metformin and obesity (body mass index [bmi] >30 kg/m^2) and the following other abnormalities:
boolean
C0087111 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2])
C0028754 (UMLS CUI [3])
C1305855 (UMLS CUI [4])
C1704258 (UMLS CUI [5,1])
C0332282 (UMLS CUI [5,2])
Obesity, Abdominal | Waist Circumference | Gender
Item
abdominal obesity (waist circumference >102 cm in men and >88 cm in women). according to national cholesterol education program-adult treatment panel (ncep-atp) iii (2001).
boolean
C0311277 (UMLS CUI [1])
C0455829 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Glycosylated hemoglobin A | Hypoglycemia Significant | Adverse effects Due to Therapeutic procedure | Diabetes Mellitus Short duration | Life Expectancy Long | Cardiovascular Disease Significant Absent
Item
glycated hemoglobin a1c (hba1c) ≥7 and ≤8.5% (after sponsor approval providers might reasonably suggest more stringent a1c goals [such as 6.5%] for selected individual patients, if this can be achieved without significant hypoglycemia or other adverse effects of treatment. appropriate patients might include those with short duration of diabetes, long life expectancy, and no significant cardiovascular disease).
boolean
C0019018 (UMLS CUI [1])
C0020615 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0879626 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0011849 (UMLS CUI [4,1])
C0439593 (UMLS CUI [4,2])
C0023671 (UMLS CUI [5,1])
C0205166 (UMLS CUI [5,2])
C0007222 (UMLS CUI [6,1])
C0750502 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Hypertriglyceridemia | Serum fasting triglyceride measurement | Serum total cholesterol measurement | Dyslipidemias Primitive
Item
hypertriglyceridemia (fasting triglyceride levels between 150 mg/dl and 600 mg/dl, cholesterol <300 mg/dl. in order to exclude patients who might be suffering from a primitive dyslipidemia).
boolean
C0020557 (UMLS CUI [1])
C0582824 (UMLS CUI [2])
C1445957 (UMLS CUI [3])
C0242339 (UMLS CUI [4,1])
C3645627 (UMLS CUI [4,2])
Decreased HDL cholesterol | Serum HDL cholesterol measurement | Gender
Item
low high-density lipoprotein (hdl) cholesterol (serum hdl-cholesterol <40 mg/dl in men and <50 mg/dl in women).
boolean
C0151691 (UMLS CUI [1])
C0428472 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Informed consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Smoking | Thyroid Diseases | Hormone replacement therapy | Antithyroid Agents | Thyroid stimulating hormone measurement | Hypothyroidism Symptoms Clinical
Item
smoking. thyroid disease even if under appropriate hormonal replacement therapy or thyroid suppressant (thyroid stimulating hormone [tsh] >5 mu/l with clinical symptoms of hypothyroidism).
boolean
C0037369 (UMLS CUI [1])
C0040128 (UMLS CUI [2])
C0282402 (UMLS CUI [3])
C0040125 (UMLS CUI [4])
C0202230 (UMLS CUI [5])
C0020676 (UMLS CUI [6,1])
C1457887 (UMLS CUI [6,2])
C0205210 (UMLS CUI [6,3])
Liver diseases | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
hepatic disease (aspartate aminotransferase [asat] or alanine aminotransferase [alat] >2 times the upper limit of normal).
boolean
C0023895 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Kidney Diseases | Creatinine measurement, serum | Coronary heart disease | Cerebrovascular Disorders | Peripheral Arterial Diseases
Item
renal disease (serum creatinine >1.7 times the upper limit of normal). a history of coronary heart disease, cerebrovascular disease, or peripheral arterial disease in the 6 months before enrollment.
boolean
C0022658 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0010068 (UMLS CUI [3])
C0007820 (UMLS CUI [4])
C1704436 (UMLS CUI [5])
Malignant Neoplasms | Lipid-lowering therapy | Systolic Pressure | Diastolic blood pressure | Triglycerides measurement | Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of malignancies. use of lipid lowering therapy. systolic blood pressure ≥180 mmhg and/or diastolic blood pressure ≥110 mmhg. triglycerides >600 mg/dl. history of chronic pancreatitis or of idiopathic acute pancreatitis.
boolean
C0006826 (UMLS CUI [1])
C0585943 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
C0202236 (UMLS CUI [5])
C0149521 (UMLS CUI [6])
C0341461 (UMLS CUI [7])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
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