ID

30068

Descripción

The Role of the Duodenum in the Pathogenesis of Insulin Resistance and Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00568620

Link

https://clinicaltrials.gov/show/NCT00568620

Palabras clave

Versiones (1)
  1. 8/5/18 8/5/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

8 de mayo de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Insulin Resistance and Type 2 Diabetes NCT00568620

Inglés

Eligibility Insulin Resistance and Type 2 Diabetes NCT00568620

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
inclusion criteria for lean, healthy control subjects:
Descripción

Inclusion criteria Healthy Control

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C2986479
1. fasting plasma glucose (fpg) < 100
Descripción

Plasma fasting glucose measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0583513
2. age 18 to 55
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
3. bmi 18.5 to 24.9 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
4. stable weight for prior 3 months
Descripción

Stable body weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0517386
inclusion criteria for prediabetic individuals:
Descripción

Inclusion criteria Prediabetic state

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0362046
1. based on american diabetes association criteria of fpg > 100 and <126
Descripción

Plasma fasting glucose measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0583513
2. age 18 to 55
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
3. bmi 35 to 60 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
4. stable weight for prior 3 months
Descripción

Stable body weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0517386
inclusion criteria for diabetic individuals:
Descripción

Inclusion criteria Diabetics

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0241863
1. diagnosis of type 2 diabetes mellitus (t2dm) for < 5 years
Descripción

Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
2. hemoglobin a1c < 8%
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
3. age 18 to 55
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
4. bmi 35 to 60 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
5. stable weight for prior 3 months
Descripción

Stable body weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0517386
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
exclusion criteria for all study subjects:
Descripción

Exclusion Criteria Study Subject All

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C0444868
1. use of any of the following medications: thiazolidinediones, dipeptidyl-peptidase iv (dpp-iv) inhibitors (e.g., sitagliptin), glp-1 analogs (e.g., exenatide).
Descripción

Thiazolidinediones | Dipeptidyl-Peptidase IV Inhibitors | Sitagliptin | GLP-1 Analogs | Exenatide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C1827106
UMLS CUI [3]
C1565750
UMLS CUI [4,1]
C0061355
UMLS CUI [4,2]
C0243071
UMLS CUI [5]
C0167117
2. subjects with t2dm who are unable to maintain adequate glycemic control (i.e., having a fasting blood glucose that exceeds 250mg/dl on two consecutive tests) while temporarily discontinuing their oral diabetes medications for the study and in whom the study physician determines insulin therapy would not be appropriate.
Descripción

Diabetes Mellitus, Non-Insulin-Dependent | Poor glycemic control | Fasting blood glucose measurement | Antidiabetics Oral Discontinued | Insulin regime Inappropriate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0342299
UMLS CUI [3]
C0428568
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1527415
UMLS CUI [4,3]
C1444662
UMLS CUI [5,1]
C0557978
UMLS CUI [5,2]
C1548788
3. females with a positive pregnancy test
Descripción

Pregnancy test positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0240802
5. prior gastric, duodenal, proximal jejunal surgery or pancreas resection 6. known malabsorptive disorder 7. history of cancer in past 5 years 8. renal insufficiency defined by serum creatinine > 1.5 mg/dl 9. hepatic enzyme elevations of greater than twice the upper limits of normal 10. current use of warfarin or clopidogrel 11. intercurrent infections 12. contraindication to nasogastric or nasojejunal feeding tube (e.g., deviated nasal septum, prior upper gastrointestinal bleed, or history of easy bleeding) 13. residence outside the greater nashville, tn area
Descripción

Operation on stomach | Duodenal surgery | Jejunal surgery Proximal | Pancreatectomy | Malabsorption Syndrome | Malignant Neoplasms | Renal Insufficiency | Creatinine measurement, serum | Elevated liver enzymes | Warfarin | Clopidogrel | Communicable Diseases | Medical contraindication Nasogastric tube | Medical contraindication Nasojejunal Tubes | Nasal septum abnormality | Upper gastrointestinal hemorrhage | Easy bleeding | Residence Remote

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0192398
UMLS CUI [2]
C3837072
UMLS CUI [3,1]
C3837064
UMLS CUI [3,2]
C0205107
UMLS CUI [4]
C0030279
UMLS CUI [5]
C0024523
UMLS CUI [6]
C0006826
UMLS CUI [7]
C1565489
UMLS CUI [8]
C0201976
UMLS CUI [9]
C0235996
UMLS CUI [10]
C0043031
UMLS CUI [11]
C0070166
UMLS CUI [12]
C0009450
UMLS CUI [13,1]
C1301624
UMLS CUI [13,2]
C0085678
UMLS CUI [14,1]
C1301624
UMLS CUI [14,2]
C0184148
UMLS CUI [15]
C0151790
UMLS CUI [16]
C0041909
UMLS CUI [17]
C2199604
UMLS CUI [18,1]
C0237096
UMLS CUI [18,2]
C0205157
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Similar models

Eligibility Insulin Resistance and Type 2 Diabetes NCT00568620

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Healthy Control
Item
inclusion criteria for lean, healthy control subjects:
boolean
C1512693 (UMLS CUI [1,1])
C2986479 (UMLS CUI [1,2])
Plasma fasting glucose measurement
Item
1. fasting plasma glucose (fpg) < 100
boolean
C0583513 (UMLS CUI [1])
Age
Item
2. age 18 to 55
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
3. bmi 18.5 to 24.9 kg/m2
boolean
C1305855 (UMLS CUI [1])
Stable body weight
Item
4. stable weight for prior 3 months
boolean
C0517386 (UMLS CUI [1])
Inclusion criteria Prediabetic state
Item
inclusion criteria for prediabetic individuals:
boolean
C1512693 (UMLS CUI [1,1])
C0362046 (UMLS CUI [1,2])
Plasma fasting glucose measurement
Item
1. based on american diabetes association criteria of fpg > 100 and <126
boolean
C0583513 (UMLS CUI [1])
Age
Item
2. age 18 to 55
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
3. bmi 35 to 60 kg/m2
boolean
C1305855 (UMLS CUI [1])
Stable body weight
Item
4. stable weight for prior 3 months
boolean
C0517386 (UMLS CUI [1])
Inclusion criteria Diabetics
Item
inclusion criteria for diabetic individuals:
boolean
C1512693 (UMLS CUI [1,1])
C0241863 (UMLS CUI [1,2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
1. diagnosis of type 2 diabetes mellitus (t2dm) for < 5 years
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
2. hemoglobin a1c < 8%
boolean
C0474680 (UMLS CUI [1])
Age
Item
3. age 18 to 55
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
4. bmi 35 to 60 kg/m2
boolean
C1305855 (UMLS CUI [1])
Stable body weight
Item
5. stable weight for prior 3 months
boolean
C0517386 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Study Subject All
Item
exclusion criteria for all study subjects:
boolean
C0680251 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,3])
Thiazolidinediones | Dipeptidyl-Peptidase IV Inhibitors | Sitagliptin | GLP-1 Analogs | Exenatide
Item
1. use of any of the following medications: thiazolidinediones, dipeptidyl-peptidase iv (dpp-iv) inhibitors (e.g., sitagliptin), glp-1 analogs (e.g., exenatide).
boolean
C1257987 (UMLS CUI [1])
C1827106 (UMLS CUI [2])
C1565750 (UMLS CUI [3])
C0061355 (UMLS CUI [4,1])
C0243071 (UMLS CUI [4,2])
C0167117 (UMLS CUI [5])
Diabetes Mellitus, Non-Insulin-Dependent | Poor glycemic control | Fasting blood glucose measurement | Antidiabetics Oral Discontinued | Insulin regime Inappropriate
Item
2. subjects with t2dm who are unable to maintain adequate glycemic control (i.e., having a fasting blood glucose that exceeds 250mg/dl on two consecutive tests) while temporarily discontinuing their oral diabetes medications for the study and in whom the study physician determines insulin therapy would not be appropriate.
boolean
C0011860 (UMLS CUI [1])
C0342299 (UMLS CUI [2])
C0428568 (UMLS CUI [3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C1444662 (UMLS CUI [4,3])
C0557978 (UMLS CUI [5,1])
C1548788 (UMLS CUI [5,2])
Pregnancy test positive
Item
3. females with a positive pregnancy test
boolean
C0240802 (UMLS CUI [1])
Operation on stomach | Duodenal surgery | Jejunal surgery Proximal | Pancreatectomy | Malabsorption Syndrome | Malignant Neoplasms | Renal Insufficiency | Creatinine measurement, serum | Elevated liver enzymes | Warfarin | Clopidogrel | Communicable Diseases | Medical contraindication Nasogastric tube | Medical contraindication Nasojejunal Tubes | Nasal septum abnormality | Upper gastrointestinal hemorrhage | Easy bleeding | Residence Remote
Item
5. prior gastric, duodenal, proximal jejunal surgery or pancreas resection 6. known malabsorptive disorder 7. history of cancer in past 5 years 8. renal insufficiency defined by serum creatinine > 1.5 mg/dl 9. hepatic enzyme elevations of greater than twice the upper limits of normal 10. current use of warfarin or clopidogrel 11. intercurrent infections 12. contraindication to nasogastric or nasojejunal feeding tube (e.g., deviated nasal septum, prior upper gastrointestinal bleed, or history of easy bleeding) 13. residence outside the greater nashville, tn area
boolean
C0192398 (UMLS CUI [1])
C3837072 (UMLS CUI [2])
C3837064 (UMLS CUI [3,1])
C0205107 (UMLS CUI [3,2])
C0030279 (UMLS CUI [4])
C0024523 (UMLS CUI [5])
C0006826 (UMLS CUI [6])
C1565489 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
C0235996 (UMLS CUI [9])
C0043031 (UMLS CUI [10])
C0070166 (UMLS CUI [11])
C0009450 (UMLS CUI [12])
C1301624 (UMLS CUI [13,1])
C0085678 (UMLS CUI [13,2])
C1301624 (UMLS CUI [14,1])
C0184148 (UMLS CUI [14,2])
C0151790 (UMLS CUI [15])
C0041909 (UMLS CUI [16])
C2199604 (UMLS CUI [17])
C0237096 (UMLS CUI [18,1])
C0205157 (UMLS CUI [18,2])
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