ID

37409

Beschreibung

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

Stichworte

Versionen (1)
  1. 24.07.19 24.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

24. Juli 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Type II Diabetes in the Not so Obese NCT02041234

Englisch

Eligibility Type II Diabetes in the Not so Obese NCT02041234

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datentyp

boolean

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

Age

Datentyp

boolean

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

Body mass index

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

Bariatric Surgery | Operative Surgical Procedure Extensive Upper abdomen

Datentyp

boolean

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

Pregnancy

Datentyp

boolean

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

Kidney Disease Requirement Dialysis

Datentyp

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.
Beschreibung

Study Subject Medically unfit General Anesthesia

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Participation Follow-up Unwilling | Participation Follow-up Unable

Datentyp

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.
Beschreibung

Randomization Unwilling

Datentyp

boolean

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

Mental disorder Unstable

Datentyp

boolean

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

Substance Use Disorders

Datentyp

boolean

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

Anti-GAD antibody positive

Datentyp

boolean

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

Fasting C-peptide level

Datentyp

boolean

Alias
UMLS CUI [1]
C2208720
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Ähnliche Modelle

Eligibility Type II Diabetes in the Not so Obese NCT02041234

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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