ID

34714

Beschreibung

Changes in Bone Turnover With Exposure to a GLP-1 Receptor Agonist; ODM derived from: https://clinicaltrials.gov/show/NCT01381926

Link

https://clinicaltrials.gov/show/NCT01381926

Stichworte

Versionen (1)
  1. 24.01.19 24.01.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

24. Januar 2019

DOI

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Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT01381926

Englisch

Eligibility Type 2 Diabetes Mellitus NCT01381926

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal women (as defined by age ≥45 years old or amenorrhea for >2years)
Beschreibung

Postmenopausal state | Age | Amenorrhea Duration

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0002453
UMLS CUI [3,2]
C0449238
type 2 dm currently not on diabetes-specific medication(s) or treated with monotherapy of metformin or a sulfonylurea. patients treated with insulin monotherapy will also be eligible if the total daily dose of insulin is ≤10units. if on a medication for diabetes prior to study entry, the medication can be discontinued for 2 weeks prior to study initiation.
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Absent | Metformin | Sulfonylurea | Insulin regime U/day

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0025598
UMLS CUI [4]
C0038766
UMLS CUI [5,1]
C0557978
UMLS CUI [5,2]
C0456683
hemoglobin a1c (hba1c) of 6.5-9.0%
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of an incretin mimetic (i.e. exenatide, liraglutide), a dpp-4 inhibitor (i.e. sitagliptin, saxagliptin), a thiazolidinedione, or oral glucocorticoids in the 6 months prior to the study will not be eligible
Beschreibung

Incretin mimetic product | exenatide | liraglutide | Dipeptidyl-Peptidase IV Inhibitors | sitagliptin | saxagliptin | Thiazolidinediones | Glucocorticoids Oral

Datentyp

boolean

Alias
UMLS CUI [1]
C1562104
UMLS CUI [2]
C0167117
UMLS CUI [3]
C1456408
UMLS CUI [4]
C1827106
UMLS CUI [5]
C1565750
UMLS CUI [6]
C1611934
UMLS CUI [7]
C1257987
UMLS CUI [8,1]
C0017710
UMLS CUI [8,2]
C1527415
known osteoporosis or patients treated with an osteoporosis-specific medication (bisphosphonate, teriparatide) or estrogen (including selective estrogen receptor modulators (serms)) or those who anticipate imminent treatment with one of these medications will be excluded from the study
Beschreibung

Osteoporosis | Pharmaceutical Preparations Osteoporosis Specific | Diphosphonates | Teriparatide | Estrogens | Selective Estrogen Receptor Modulators

Datentyp

boolean

Alias
UMLS CUI [1]
C0029456
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0029456
UMLS CUI [2,3]
C0205369
UMLS CUI [3]
C0012544
UMLS CUI [4]
C0070093
UMLS CUI [5]
C0014939
UMLS CUI [6]
C0732611
chronic kidney disease (calculated gfr <30 ml/min) or a disease known to affect bone turnover (i.e. paget disease, osteogenesis imperfecta, hiv) will be excluded from the study.
Beschreibung

Chronic Kidney Disease | Glomerular Filtration Rate | Disease Affecting Bone remodeling | Paget's disease | Osteogenesis Imperfecta | HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C1561643
UMLS CUI [2]
C0017654
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0085268
UMLS CUI [4]
C0029401
UMLS CUI [5]
C0029434
UMLS CUI [6]
C0019693
history of pancreatitis
Beschreibung

Pancreatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0030305
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Ähnliche Modelle

Eligibility Type 2 Diabetes Mellitus NCT01381926

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state | Age | Amenorrhea Duration
Item
postmenopausal women (as defined by age ≥45 years old or amenorrhea for >2years)
boolean
C0232970 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0002453 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Absent | Metformin | Sulfonylurea | Insulin regime U/day
Item
type 2 dm currently not on diabetes-specific medication(s) or treated with monotherapy of metformin or a sulfonylurea. patients treated with insulin monotherapy will also be eligible if the total daily dose of insulin is ≤10units. if on a medication for diabetes prior to study entry, the medication can be discontinued for 2 weeks prior to study initiation.
boolean
C0011860 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C0557978 (UMLS CUI [5,1])
C0456683 (UMLS CUI [5,2])
Hemoglobin A1c measurement
Item
hemoglobin a1c (hba1c) of 6.5-9.0%
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Incretin mimetic product | exenatide | liraglutide | Dipeptidyl-Peptidase IV Inhibitors | sitagliptin | saxagliptin | Thiazolidinediones | Glucocorticoids Oral
Item
use of an incretin mimetic (i.e. exenatide, liraglutide), a dpp-4 inhibitor (i.e. sitagliptin, saxagliptin), a thiazolidinedione, or oral glucocorticoids in the 6 months prior to the study will not be eligible
boolean
C1562104 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1456408 (UMLS CUI [3])
C1827106 (UMLS CUI [4])
C1565750 (UMLS CUI [5])
C1611934 (UMLS CUI [6])
C1257987 (UMLS CUI [7])
C0017710 (UMLS CUI [8,1])
C1527415 (UMLS CUI [8,2])
Osteoporosis | Pharmaceutical Preparations Osteoporosis Specific | Diphosphonates | Teriparatide | Estrogens | Selective Estrogen Receptor Modulators
Item
known osteoporosis or patients treated with an osteoporosis-specific medication (bisphosphonate, teriparatide) or estrogen (including selective estrogen receptor modulators (serms)) or those who anticipate imminent treatment with one of these medications will be excluded from the study
boolean
C0029456 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0029456 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
C0012544 (UMLS CUI [3])
C0070093 (UMLS CUI [4])
C0014939 (UMLS CUI [5])
C0732611 (UMLS CUI [6])
Chronic Kidney Disease | Glomerular Filtration Rate | Disease Affecting Bone remodeling | Paget's disease | Osteogenesis Imperfecta | HIV Infection
Item
chronic kidney disease (calculated gfr <30 ml/min) or a disease known to affect bone turnover (i.e. paget disease, osteogenesis imperfecta, hiv) will be excluded from the study.
boolean
C1561643 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0085268 (UMLS CUI [3,3])
C0029401 (UMLS CUI [4])
C0029434 (UMLS CUI [5])
C0019693 (UMLS CUI [6])
Pancreatitis
Item
history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
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