ID

43890

Beschreibung

Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00361153

Link

https://clinicaltrials.gov/show/NCT00361153

Stichworte

Versionen (2)
  1. 30.06.17 30.06.17 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00361153

Englisch

Eligibility Type 2 Diabetes Mellitus NCT00361153

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects meeting the following criteria at the screening visit will be eligible to participate in the trial:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
have given written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
ages 18 to 75 years, inclusive
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of type 2 diabetes mellitus of at least 3 months duration
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
hba1c 7.0- 10.0%, inclusive
Beschreibung

Glycosylated hemoglobin A

Datentyp

boolean

Alias
UMLS CUI [1]
C0019018
antidiabetic treatment may include oral agents; all antidiabetic agents must be withdrawn before randomization
Beschreibung

Antidiabetics | Antidiabetics Oral | Antidiabetics To be stopped

Datentyp

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1272691
women may be enrolled if they are not pregnant (negative serum βhcg at the screening visit), are not breast-feeding, and do not plan to become pregnant during the trial. in addition, they must either have had a hysterectomy or tubal ligation at least 6 months before signing informed consent, be post-menopausal for 1 year, or practicing an acceptable method of birth control. an acceptable method of birth control may be oral, injectable or implantable hormonal contraceptives, intrauterine device, diaphragm plus spermicide, or female condom plus spermicide. abstinence, partner's use of condoms, and partner's vasectomy are not acceptable methods of contraception
Beschreibung

Gender Serum pregnancy test (B-HCG) Negative | Breast Feeding Absent | Planned Pregnancy Absent | Hysterectomy | Tubal Ligation | Postmenopausal state | Gender Contraceptive methods | Oral contraception | Injectable contraception | Hormonal contraception Implantable | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Sexual Abstinence Unacceptable | Partner Condom Unacceptable | Partner had vasectomy Unacceptable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0032992
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0020699
UMLS CUI [5]
C0520483
UMLS CUI [6]
C0232970
UMLS CUI [7,1]
C0079399
UMLS CUI [7,2]
C0700589
UMLS CUI [8]
C0029151
UMLS CUI [9]
C1262153
UMLS CUI [10,1]
C2985296
UMLS CUI [10,2]
C0021102
UMLS CUI [11]
C0021900
UMLS CUI [12]
C0042241
UMLS CUI [13]
C0087145
UMLS CUI [14]
C0221829
UMLS CUI [15,1]
C0036899
UMLS CUI [15,2]
C1883420
UMLS CUI [16,1]
C0682323
UMLS CUI [16,2]
C0677582
UMLS CUI [16,3]
C1883420
UMLS CUI [17,1]
C0420842
UMLS CUI [17,2]
C1883420
bmi 25 - 45 kg/m sq, inclusive
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects are excluded from participation in the study if any of the following criteria apply:
Beschreibung

Criteria None

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0549184
type 1 diabetes mellitus or history of diabetic ketoacidosis
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011880
treatment with lipid or blood pressure lowering therapy that has not been stable for three months before randomization
Beschreibung

Antilipemic agent Unstable | Antihypertensive Agents Unstable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086440
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0443343
treatment with welchol, cholestyramine or colestipol for hyperlipidemia within the last 3 months
Beschreibung

Welchol | Cholestyramine | Colestipol | Therapeutic procedure Hyperlipidemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0939530
UMLS CUI [2]
C0008402
UMLS CUI [3]
C0009279
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0020473
treatment with thiazolidinediones
Beschreibung

Thiazolidinediones

Datentyp

boolean

Alias
UMLS CUI [1]
C1257987
history of dysphagia, swallowing disorders, or intestinal motility disorder
Beschreibung

Deglutition Disorders | Swallowing problem | Motility disorder of intestine

Datentyp

boolean

Alias
UMLS CUI [1]
C0011168
UMLS CUI [2]
C0392678
UMLS CUI [3]
C0400865
serum triglyceride >500 mg/dl at visit 1
Beschreibung

Serum Triglyceride Measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0542495
serum ldl-c <60 mg/dl at visit 1
Beschreibung

Low density lipoprotein cholesterol measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202117
any condition or therapy which, in the opinion of the investigator, poses a risk to the subject or makes participation not in the subject's best interest
Beschreibung

Condition At risk Study Subject | Therapeutic procedure At risk Study Subject | Condition Study Subject Participation Status Unfavorable | Therapeutic procedure Study Subject Participation Status Unfavorable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0681850
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0681850
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C3640815
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C3640815
use of any investigational drug within 30 days before randomization
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
chronic treatment with oral corticosteroids
Beschreibung

Adrenal Cortex Hormones Oral chronic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0205191
history of hyperthyroidism and/or treatment with thyroid hormone/ levothyroxine
Beschreibung

Hyperthyroidism | Thyroid Hormones | Thyroxine

Datentyp

boolean

Alias
UMLS CUI [1]
C0020550
UMLS CUI [2]
C0040135
UMLS CUI [3]
C0040165
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Ähnliche Modelle

Eligibility Type 2 Diabetes Mellitus NCT00361153

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
subjects meeting the following criteria at the screening visit will be eligible to participate in the trial:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Informed Consent
Item
have given written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
ages 18 to 75 years, inclusive
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
diagnosis of type 2 diabetes mellitus of at least 3 months duration
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Glycosylated hemoglobin A
Item
hba1c 7.0- 10.0%, inclusive
boolean
C0019018 (UMLS CUI [1])
Antidiabetics | Antidiabetics Oral | Antidiabetics To be stopped
Item
antidiabetic treatment may include oral agents; all antidiabetic agents must be withdrawn before randomization
boolean
C0935929 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0935929 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
Gender Serum pregnancy test (B-HCG) Negative | Breast Feeding Absent | Planned Pregnancy Absent | Hysterectomy | Tubal Ligation | Postmenopausal state | Gender Contraceptive methods | Oral contraception | Injectable contraception | Hormonal contraception Implantable | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Sexual Abstinence Unacceptable | Partner Condom Unacceptable | Partner had vasectomy Unacceptable
Item
women may be enrolled if they are not pregnant (negative serum βhcg at the screening visit), are not breast-feeding, and do not plan to become pregnant during the trial. in addition, they must either have had a hysterectomy or tubal ligation at least 6 months before signing informed consent, be post-menopausal for 1 year, or practicing an acceptable method of birth control. an acceptable method of birth control may be oral, injectable or implantable hormonal contraceptives, intrauterine device, diaphragm plus spermicide, or female condom plus spermicide. abstinence, partner's use of condoms, and partner's vasectomy are not acceptable methods of contraception
boolean
C0079399 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0020699 (UMLS CUI [4])
C0520483 (UMLS CUI [5])
C0232970 (UMLS CUI [6])
C0079399 (UMLS CUI [7,1])
C0700589 (UMLS CUI [7,2])
C0029151 (UMLS CUI [8])
C1262153 (UMLS CUI [9])
C2985296 (UMLS CUI [10,1])
C0021102 (UMLS CUI [10,2])
C0021900 (UMLS CUI [11])
C0042241 (UMLS CUI [12])
C0087145 (UMLS CUI [13])
C0221829 (UMLS CUI [14])
C0036899 (UMLS CUI [15,1])
C1883420 (UMLS CUI [15,2])
C0682323 (UMLS CUI [16,1])
C0677582 (UMLS CUI [16,2])
C1883420 (UMLS CUI [16,3])
C0420842 (UMLS CUI [17,1])
C1883420 (UMLS CUI [17,2])
Body mass index
Item
bmi 25 - 45 kg/m sq, inclusive
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Criteria None
Item
subjects are excluded from participation in the study if any of the following criteria apply:
boolean
C0243161 (UMLS CUI [1,1])
C0549184 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis
Item
type 1 diabetes mellitus or history of diabetic ketoacidosis
boolean
C0011854 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
Antilipemic agent Unstable | Antihypertensive Agents Unstable
Item
treatment with lipid or blood pressure lowering therapy that has not been stable for three months before randomization
boolean
C0086440 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Welchol | Cholestyramine | Colestipol | Therapeutic procedure Hyperlipidemia
Item
treatment with welchol, cholestyramine or colestipol for hyperlipidemia within the last 3 months
boolean
C0939530 (UMLS CUI [1])
C0008402 (UMLS CUI [2])
C0009279 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0020473 (UMLS CUI [4,2])
Thiazolidinediones
Item
treatment with thiazolidinediones
boolean
C1257987 (UMLS CUI [1])
Deglutition Disorders | Swallowing problem | Motility disorder of intestine
Item
history of dysphagia, swallowing disorders, or intestinal motility disorder
boolean
C0011168 (UMLS CUI [1])
C0392678 (UMLS CUI [2])
C0400865 (UMLS CUI [3])
Serum Triglyceride Measurement
Item
serum triglyceride >500 mg/dl at visit 1
boolean
C0542495 (UMLS CUI [1])
Low density lipoprotein cholesterol measurement
Item
serum ldl-c <60 mg/dl at visit 1
boolean
C0202117 (UMLS CUI [1])
Condition At risk Study Subject | Therapeutic procedure At risk Study Subject | Condition Study Subject Participation Status Unfavorable | Therapeutic procedure Study Subject Participation Status Unfavorable
Item
any condition or therapy which, in the opinion of the investigator, poses a risk to the subject or makes participation not in the subject's best interest
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0681850 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C3640815 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C3640815 (UMLS CUI [4,3])
Investigational New Drugs
Item
use of any investigational drug within 30 days before randomization
boolean
C0013230 (UMLS CUI [1])
Adrenal Cortex Hormones Oral chronic
Item
chronic treatment with oral corticosteroids
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
Hyperthyroidism | Thyroid Hormones | Thyroxine
Item
history of hyperthyroidism and/or treatment with thyroid hormone/ levothyroxine
boolean
C0020550 (UMLS CUI [1])
C0040135 (UMLS CUI [2])
C0040165 (UMLS CUI [3])
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