ID

37350

Beschreibung

Early Sleeve Gastrectomy In New Onset Diabetic Obese Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02488733

Link

https://clinicaltrials.gov/show/NCT02488733

Stichworte

Versionen (1)
  1. 19.07.19 19.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

19. Juli 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02488733

Englisch

Eligibility Type 2 Diabetes Mellitus NCT02488733

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. no contraindication for laparoscopic surgery or general anaesthesia.
Beschreibung

Medical contraindication Absent Laparoscopic Surgery | Medical contraindication Absent General Anesthesia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0751429
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0002915
2. age ≥20 and ≤65 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. bmi of between 30 and 42 kg/m2.
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
4. documented new diagnosis of type 2 diabetes mellitus obtained according to the following american diabetes association parameters: fasting blood glucose ≥ 126 mg/dl (7.0 mmol/l) and/or hba1c ≥ 6.5% and no more than 8 months from enrollment in the study.
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Fasting blood glucose measurement | Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0428568
UMLS CUI [3]
C0474680
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous bariatric surgery or major abdominal surgery.
Beschreibung

Bariatric Surgery | Abdominal surgery Major

Datentyp

boolean

Alias
UMLS CUI [1]
C1456587
UMLS CUI [2,1]
C0198482
UMLS CUI [2,2]
C0205164
2. patients with t2dm diagnosis treated with insulin.
Beschreibung

Insulin regime Non-Insulin-Dependent Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0011860
3. evidence of complications connected to diabetes at any stage (diabetic retinopathy, diabetic nephropathy/microalbuminuria, cardiovascular disease or neuropathy).
Beschreibung

Complications of Diabetes Mellitus Stage Any | Diabetic Retinopathy | Diabetic Nephropathy | Microalbuminuria Diabetic | Cardiovascular Disease | Neuropathy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C1306673
UMLS CUI [1,3]
C1552551
UMLS CUI [2]
C0011884
UMLS CUI [3]
C0011881
UMLS CUI [4,1]
C0730345
UMLS CUI [4,2]
C0241863
UMLS CUI [5]
C0007222
UMLS CUI [6]
C0442874
4. cardiovascular diseases such as ischemia / coronary artery disease, arrhythmia, peripheral vascular diseases, congestive heart failure, history of heart attacks.
Beschreibung

Cardiovascular Diseases | Ischemia | Coronary Artery Disease | Cardiac Arrhythmia | Peripheral Vascular Diseases | Congestive heart failure | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0022116
UMLS CUI [3]
C1956346
UMLS CUI [4]
C0003811
UMLS CUI [5]
C0085096
UMLS CUI [6]
C0018802
UMLS CUI [7]
C0027051
5. kidney diseases including nephro-vascular hypertension, stenosis of the renal artery or chronic renal insufficiency.
Beschreibung

Kidney Diseases | Hypertension, Renovascular | Renal Artery Stenosis | Chronic Kidney Insufficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0020545
UMLS CUI [3]
C0035067
UMLS CUI [4]
C0403447
6. pregnancy
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
7. diagnosis of psychiatric illness (including dementia, severe depression, history of suicide attempts) or abuse of alcohol or drugs in the previous 5 years.
Beschreibung

Mental disorders | Dementia | Severe depression | Suicide attempt | Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0497327
UMLS CUI [3]
C0588008
UMLS CUI [4]
C0038663
UMLS CUI [5]
C0038586
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Ähnliche Modelle

Eligibility Type 2 Diabetes Mellitus NCT02488733

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Medical contraindication Absent Laparoscopic Surgery | Medical contraindication Absent General Anesthesia
Item
1. no contraindication for laparoscopic surgery or general anaesthesia.
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0751429 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0002915 (UMLS CUI [2,3])
Age
Item
2. age ≥20 and ≤65 years.
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
3. bmi of between 30 and 42 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Fasting blood glucose measurement | Hemoglobin A1c measurement
Item
4. documented new diagnosis of type 2 diabetes mellitus obtained according to the following american diabetes association parameters: fasting blood glucose ≥ 126 mg/dl (7.0 mmol/l) and/or hba1c ≥ 6.5% and no more than 8 months from enrollment in the study.
boolean
C0011860 (UMLS CUI [1])
C0428568 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Bariatric Surgery | Abdominal surgery Major
Item
1. previous bariatric surgery or major abdominal surgery.
boolean
C1456587 (UMLS CUI [1])
C0198482 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
Insulin regime Non-Insulin-Dependent Diabetes Mellitus
Item
2. patients with t2dm diagnosis treated with insulin.
boolean
C0557978 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
Complications of Diabetes Mellitus Stage Any | Diabetic Retinopathy | Diabetic Nephropathy | Microalbuminuria Diabetic | Cardiovascular Disease | Neuropathy
Item
3. evidence of complications connected to diabetes at any stage (diabetic retinopathy, diabetic nephropathy/microalbuminuria, cardiovascular disease or neuropathy).
boolean
C0342257 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0011884 (UMLS CUI [2])
C0011881 (UMLS CUI [3])
C0730345 (UMLS CUI [4,1])
C0241863 (UMLS CUI [4,2])
C0007222 (UMLS CUI [5])
C0442874 (UMLS CUI [6])
Cardiovascular Diseases | Ischemia | Coronary Artery Disease | Cardiac Arrhythmia | Peripheral Vascular Diseases | Congestive heart failure | Myocardial Infarction
Item
4. cardiovascular diseases such as ischemia / coronary artery disease, arrhythmia, peripheral vascular diseases, congestive heart failure, history of heart attacks.
boolean
C0007222 (UMLS CUI [1])
C0022116 (UMLS CUI [2])
C1956346 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0085096 (UMLS CUI [5])
C0018802 (UMLS CUI [6])
C0027051 (UMLS CUI [7])
Kidney Diseases | Hypertension, Renovascular | Renal Artery Stenosis | Chronic Kidney Insufficiency
Item
5. kidney diseases including nephro-vascular hypertension, stenosis of the renal artery or chronic renal insufficiency.
boolean
C0022658 (UMLS CUI [1])
C0020545 (UMLS CUI [2])
C0035067 (UMLS CUI [3])
C0403447 (UMLS CUI [4])
Pregnancy
Item
6. pregnancy
boolean
C0032961 (UMLS CUI [1])
Mental disorders | Dementia | Severe depression | Suicide attempt | Substance Use Disorders
Item
7. diagnosis of psychiatric illness (including dementia, severe depression, history of suicide attempts) or abuse of alcohol or drugs in the previous 5 years.
boolean
C0004936 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C0588008 (UMLS CUI [3])
C0038663 (UMLS CUI [4])
C0038586 (UMLS CUI [5])
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