ID

37409

Description

Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes Versus Best Medical Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT02041234

Link

https://clinicaltrials.gov/show/NCT02041234

Keywords

Versions (1)
  1. 7/24/19 7/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 24, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Type II Diabetes in the Not so Obese NCT02041234

English

Eligibility Type II Diabetes in the Not so Obese NCT02041234

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. established diagnosis of dm2 = or < 5 years
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
2. age 25-65
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. bmi 27-32.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
4. hba1c = 8%, on insulin treatment.or starting on insulin/incretin analogs
Description

Hemoglobin A1c measurement | Insulin regime | Insulin Analog | Incretin Analog

Data type

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2]
C0557978
UMLS CUI [3]
C2825028
UMLS CUI [4,1]
C1562292
UMLS CUI [4,2]
C0243071
5. at least one of the following co-morbidities on treatment: hypertension, hyperlipidaemia, micro/macro-proteinuria or =class i nephropathy, retinopathy, ischaemic heart disease.
Description

Therapeutic procedure Comorbidity | Hypertensive disease | Hyperlipidemia | Microproteinuria | Macro Proteinuria | Kidney Disease Class | Retinal Disease | Myocardial Ischemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0009488
UMLS CUI [2]
C0020538
UMLS CUI [3]
C0020473
UMLS CUI [4]
C0443257
UMLS CUI [5,1]
C2984010
UMLS CUI [5,2]
C0033687
UMLS CUI [6,1]
C0022658
UMLS CUI [6,2]
C0456387
UMLS CUI [7]
C0035309
UMLS CUI [8]
C0151744
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects who had previous bariatric surgery or extensive upper abdominal surgery
Description

Bariatric Surgery | Operative Surgical Procedure Extensive Upper abdomen

Data type

boolean

Alias
UMLS CUI [1]
C1456587
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0205231
UMLS CUI [2,3]
C2937240
2. pregnant subjects.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
3. nephropathy requiring dialysis
Description

Kidney Disease Requirement Dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946
4. subjects who are not fit for general anaesthesia.
Description

Study Subject Medically unfit General Anesthesia

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C3841806
UMLS CUI [1,3]
C0002915
5. subjects who are unsuitable for rygb for whatever reason, medical/surgical/psychological.
Description

Study Subject Inappropriate Roux-en-Y Anastomosis | Etiology Medical | Etiology Surgical | Etiology Psychological

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0002804
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0205476
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0543467
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0205486
6. subjects who are unwilling or possibly unable to participate in the follow up process.
Description

Participation Follow-up Unwilling | Participation Follow-up Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C3274571
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C3274571
UMLS CUI [2,3]
C1299582
7. subjects who are reluctant to be randomised into the two study groups.
Description

Randomization Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0558080
8. subjects who suffers from unstable psychiatric illness
Description

Mental disorder Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0443343
9. subjects who are active substance abusers
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
10. glutamic acid decarboxylase antibody positive.
Description

Anti-GAD antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C1167896
11. fasting c-peptide < 300 nm
Description

Fasting C-peptide level

Data type

boolean

Alias
UMLS CUI [1]
C2208720
Back to the top of the page

Similar models

Eligibility Type II Diabetes in the Not so Obese NCT02041234

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
1. established diagnosis of dm2 = or < 5 years
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age
Item
2. age 25-65
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
3. bmi 27-32.
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement | Insulin regime | Insulin Analog | Incretin Analog
Item
4. hba1c = 8%, on insulin treatment.or starting on insulin/incretin analogs
boolean
C0474680 (UMLS CUI [1])
C0557978 (UMLS CUI [2])
C2825028 (UMLS CUI [3])
C1562292 (UMLS CUI [4,1])
C0243071 (UMLS CUI [4,2])
Therapeutic procedure Comorbidity | Hypertensive disease | Hyperlipidemia | Microproteinuria | Macro Proteinuria | Kidney Disease Class | Retinal Disease | Myocardial Ischemia
Item
5. at least one of the following co-morbidities on treatment: hypertension, hyperlipidaemia, micro/macro-proteinuria or =class i nephropathy, retinopathy, ischaemic heart disease.
boolean
C0087111 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2])
C0020473 (UMLS CUI [3])
C0443257 (UMLS CUI [4])
C2984010 (UMLS CUI [5,1])
C0033687 (UMLS CUI [5,2])
C0022658 (UMLS CUI [6,1])
C0456387 (UMLS CUI [6,2])
C0035309 (UMLS CUI [7])
C0151744 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Bariatric Surgery | Operative Surgical Procedure Extensive Upper abdomen
Item
1. subjects who had previous bariatric surgery or extensive upper abdominal surgery
boolean
C1456587 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
C2937240 (UMLS CUI [2,3])
Pregnancy
Item
2. pregnant subjects.
boolean
C0032961 (UMLS CUI [1])
Kidney Disease Requirement Dialysis
Item
3. nephropathy requiring dialysis
boolean
C0022658 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
Study Subject Medically unfit General Anesthesia
Item
4. subjects who are not fit for general anaesthesia.
boolean
C0681850 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C0002915 (UMLS CUI [1,3])
Study Subject Inappropriate Roux-en-Y Anastomosis | Etiology Medical | Etiology Surgical | Etiology Psychological
Item
5. subjects who are unsuitable for rygb for whatever reason, medical/surgical/psychological.
boolean
C0681850 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0002804 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0205476 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0205486 (UMLS CUI [4,2])
Participation Follow-up Unwilling | Participation Follow-up Unable
Item
6. subjects who are unwilling or possibly unable to participate in the follow up process.
boolean
C0679823 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0679823 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Randomization Unwilling
Item
7. subjects who are reluctant to be randomised into the two study groups.
boolean
C0034656 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Mental disorder Unstable
Item
8. subjects who suffers from unstable psychiatric illness
boolean
C0004936 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Substance Use Disorders
Item
9. subjects who are active substance abusers
boolean
C0038586 (UMLS CUI [1])
Anti-GAD antibody positive
Item
10. glutamic acid decarboxylase antibody positive.
boolean
C1167896 (UMLS CUI [1])
Fasting C-peptide level
Item
11. fasting c-peptide < 300 nm
boolean
C2208720 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial