ID

35737

Description

To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT02299388

Lien

https://clinicaltrials.gov/show/NCT02299388

Mots-clés

Versions (1)
  1. 19/03/2019 19/03/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

19 mars 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Non-Insulin-Dependent NCT02299388

Anglais

Eligibility Diabetes Mellitus, Non-Insulin-Dependent NCT02299388

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes, as an adjunct to diet and exercise to improve glycemic control (as per approved label.
Description

Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Glycaemia control Improve

Type de données

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
UMLS CUI [4,1]
C3267174
UMLS CUI [4,2]
C0184511
hba1c>7% and ≤10.5% at randomization.
Description

Hemoglobin A1c measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0474680
men and women of 18-75 years of age.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
women of childbearing potential must agree to use contraception or must not otherwise be at risk of becoming pregnant. a urine pregnancy test will be done at the time of screening and then every 4 weeks for the duration of 8 weeks. if positive, this will be confirmed with a serum pregnancy test which if positive, appropriate action will be taken as outlined in the detailed protocol.
Description

Childbearing Potential Contraceptive methods | Childbearing Potential Urine pregnancy test | Childbearing Potential Serum pregnancy test

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430056
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430064
blood pressure≥ 130/80 mm hg and ≤160/100mmhg on stable treatment (no change in anti hypertensive treatment for 3 months prior to screening) or no treatment. no change in treatment for bp over 8 weeks of the study will be allowed.
Description

Treatment Stable Blood Pressure | Antihypertensive therapy unchanged | Treatment Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0005823
UMLS CUI [2,1]
C0585941
UMLS CUI [2,2]
C0442739
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0332197
patient understands the study procedures, alternative treatments are available, and the risks involved with the study, and voluntarily agree to participate by providing written informed consent.
Description

Comprehension Study Protocol | Informed Consent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. type 1 diabetes and/or history of ketoacidosis determined by medical history.
Description

Diabetes Mellitus, Insulin-Dependent | Ketoacidosis

Type de données

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0220982
2. history of severe diabetic or autonomic neuropathy, gastroparesis or limb ulceration or amputation.
Description

Diabetic Neuropathy Severe | Autonomic neuropathy Severe | Gastroparesis | Limb Ulceration | Amputation of limb

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011882
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0259749
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0152020
UMLS CUI [4,1]
C0015385
UMLS CUI [4,2]
C3887532
UMLS CUI [5]
C0002689
3. therapy with dpp-4 inhibitor, or glp -1 analog or receptor agonist in the past 6 months.
Description

Dipeptidyl Peptidase-4 Inhibitor | GLP-1 Analogue | GLP-1 Receptor Agonist

Type de données

boolean

Alias
UMLS CUI [1]
C3537225
UMLS CUI [2]
C3273809
UMLS CUI [3]
C2917359
4. pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.
Description

Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
5. patients on corticosteroids within 3 months or recurrent continuous corticosteroid treatment (>2 weeks).
Description

Adrenal Cortex Hormones | Steroid therapy Continuous Recurrent

Type de données

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C0549178
UMLS CUI [2,3]
C2945760
6. use of weight loss drugs within 3 months of screening or weight loss of ≥10 % in the last 6 months.
Description

Weight-Loss Agents | Weight loss Percentage Timespan

Type de données

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2,1]
C1262477
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0872291
7. surgery in the past 30 days prior to screening and/or any serious or chronic illness within 6 months or anticipated surgery during the trial period.
Description

Operative Surgical Procedures | Illness Serious | Chronic disease | Operative Surgical Procedures Anticipated

Type de données

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0008679
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C3840775
8. serum creatinine >1.4mg/dl (women)/>1.5mg/dl (men). 9. serum triglyceride level >500 mg/dl. 10. history of pancreatitis. 11. history of drug or alcohol abuse. 12. poor mental function or any reason to expect patient difficulty in complying with study requirements.
Description

Creatinine measurement, serum | Gender | Triglycerides measurement | Pancreatitis | Substance Use Disorders | Mental function Poor | Difficulty with Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0202236
UMLS CUI [4]
C0030305
UMLS CUI [5]
C0038586
UMLS CUI [6,1]
C0563143
UMLS CUI [6,2]
C0542537
UMLS CUI [7,1]
C0332218
UMLS CUI [7,2]
C0525058
13. contraindications to liraglutide: personal or family history of medullary thyroid cancer or men-2 syndrome 14. known or suspected allergy to liraglutide. 15. diagnosed secondary hypertension.
Description

Medical contraindication Liraglutide | History of Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Hypersensitivity Liraglutide | Hypersensitivity Suspected Liraglutide | Secondary hypertension

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1456408
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0238462
UMLS CUI [3]
C1833921
UMLS CUI [4,1]
C0027662
UMLS CUI [4,2]
C0332307
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C1456408
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0750491
UMLS CUI [6,3]
C1456408
UMLS CUI [7]
C0155616
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Similar models

Eligibility Diabetes Mellitus, Non-Insulin-Dependent NCT02299388

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Glycaemia control Improve
Item
type 2 diabetes, as an adjunct to diet and exercise to improve glycemic control (as per approved label.
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C3267174 (UMLS CUI [4,1])
C0184511 (UMLS CUI [4,2])
Hemoglobin A1c measurement
Item
hba1c>7% and ≤10.5% at randomization.
boolean
C0474680 (UMLS CUI [1])
Age
Item
men and women of 18-75 years of age.
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Childbearing Potential Urine pregnancy test | Childbearing Potential Serum pregnancy test
Item
women of childbearing potential must agree to use contraception or must not otherwise be at risk of becoming pregnant. a urine pregnancy test will be done at the time of screening and then every 4 weeks for the duration of 8 weeks. if positive, this will be confirmed with a serum pregnancy test which if positive, appropriate action will be taken as outlined in the detailed protocol.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430056 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430064 (UMLS CUI [3,2])
Treatment Stable Blood Pressure | Antihypertensive therapy unchanged | Treatment Absent
Item
blood pressure≥ 130/80 mm hg and ≤160/100mmhg on stable treatment (no change in anti hypertensive treatment for 3 months prior to screening) or no treatment. no change in treatment for bp over 8 weeks of the study will be allowed.
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,3])
C0585941 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Comprehension Study Protocol | Informed Consent
Item
patient understands the study procedures, alternative treatments are available, and the risks involved with the study, and voluntarily agree to participate by providing written informed consent.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Ketoacidosis
Item
1. type 1 diabetes and/or history of ketoacidosis determined by medical history.
boolean
C0011854 (UMLS CUI [1])
C0220982 (UMLS CUI [2])
Diabetic Neuropathy Severe | Autonomic neuropathy Severe | Gastroparesis | Limb Ulceration | Amputation of limb
Item
2. history of severe diabetic or autonomic neuropathy, gastroparesis or limb ulceration or amputation.
boolean
C0011882 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0259749 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0152020 (UMLS CUI [3])
C0015385 (UMLS CUI [4,1])
C3887532 (UMLS CUI [4,2])
C0002689 (UMLS CUI [5])
Dipeptidyl Peptidase-4 Inhibitor | GLP-1 Analogue | GLP-1 Receptor Agonist
Item
3. therapy with dpp-4 inhibitor, or glp -1 analog or receptor agonist in the past 6 months.
boolean
C3537225 (UMLS CUI [1])
C3273809 (UMLS CUI [2])
C2917359 (UMLS CUI [3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent
Item
4. pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Adrenal Cortex Hormones | Steroid therapy Continuous Recurrent
Item
5. patients on corticosteroids within 3 months or recurrent continuous corticosteroid treatment (>2 weeks).
boolean
C0001617 (UMLS CUI [1])
C0149783 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C2945760 (UMLS CUI [2,3])
Weight-Loss Agents | Weight loss Percentage Timespan
Item
6. use of weight loss drugs within 3 months of screening or weight loss of ≥10 % in the last 6 months.
boolean
C0376606 (UMLS CUI [1])
C1262477 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
Operative Surgical Procedures | Illness Serious | Chronic disease | Operative Surgical Procedures Anticipated
Item
7. surgery in the past 30 days prior to screening and/or any serious or chronic illness within 6 months or anticipated surgery during the trial period.
boolean
C0543467 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0008679 (UMLS CUI [3])
C0543467 (UMLS CUI [4,1])
C3840775 (UMLS CUI [4,2])
Creatinine measurement, serum | Gender | Triglycerides measurement | Pancreatitis | Substance Use Disorders | Mental function Poor | Difficulty with Protocol Compliance
Item
8. serum creatinine >1.4mg/dl (women)/>1.5mg/dl (men). 9. serum triglyceride level >500 mg/dl. 10. history of pancreatitis. 11. history of drug or alcohol abuse. 12. poor mental function or any reason to expect patient difficulty in complying with study requirements.
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0202236 (UMLS CUI [3])
C0030305 (UMLS CUI [4])
C0038586 (UMLS CUI [5])
C0563143 (UMLS CUI [6,1])
C0542537 (UMLS CUI [6,2])
C0332218 (UMLS CUI [7,1])
C0525058 (UMLS CUI [7,2])
Medical contraindication Liraglutide | History of Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Hypersensitivity Liraglutide | Hypersensitivity Suspected Liraglutide | Secondary hypertension
Item
13. contraindications to liraglutide: personal or family history of medullary thyroid cancer or men-2 syndrome 14. known or suspected allergy to liraglutide. 15. diagnosed secondary hypertension.
boolean
C1301624 (UMLS CUI [1,1])
C1456408 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0238462 (UMLS CUI [2,2])
C1833921 (UMLS CUI [3])
C0027662 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C1456408 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C1456408 (UMLS CUI [6,3])
C0155616 (UMLS CUI [7])
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