ID

33136

Descripción

Surgery Or Lifestyle Intervention for Type 2 Diabetes (SOLID); ODM derived from: https://clinicaltrials.gov/show/NCT01040468

Link

https://clinicaltrials.gov/show/NCT01040468

Palabras clave

Versiones (1)
  1. 29/11/18 29/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

29 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT01040468

Inglés

Eligibility Type 2 Diabetes NCT01040468

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
ages 18 to 65 years old.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of type 2 diabetes.
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
individuals with a bmi of 30-40 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
approval for bariatric surgery (as confirmed by medical evaluation)
Descripción

Approval Bariatric Surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205540
UMLS CUI [1,2]
C1456587
insurance coverage for bariatric surgery
Descripción

Insurance Coverage Bariatric Surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0376629
UMLS CUI [1,2]
C1456587
willingness to change diet, physical activity and weight.
Descripción

Change in diet Willing | Change Physical activity Willing | Change Body Weight Willing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3671772
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0392747
UMLS CUI [2,2]
C0026606
UMLS CUI [2,3]
C0600109
UMLS CUI [3,1]
C0392747
UMLS CUI [3,2]
C0005910
UMLS CUI [3,3]
C0600109
ability to communicate with the investigator and be legally competent, provide written informed consent.
Descripción

Able to communicate Research Personnel | Competence Legal | Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0035173
UMLS CUI [2,1]
C0086035
UMLS CUI [2,2]
C1301860
UMLS CUI [3]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of type 1 diabetes, diagnosis of maturity-onset diabetes of the young (mody), or latent autoimmune diabetes in adults (lada) (all of which are associated with ß-cell destruction), daily insulin requirements > 100 units, and poor preoperative glycemic control, as indicated by a hba1c > 6.5 - ≤ 8.5 or hba1c > 8.6 - < 9.5 (individuals with this hba1c value will require medical clearance and approval from the study physician).
Descripción

Diabetes Mellitus, Insulin-Dependent | Maturity onset diabetes mellitus in young | Latent Autoimmune Diabetes in Adults | Beta Cell Destruction | Requirement Insulin U/day | Poor glycemic control Preoperative | Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0342276
UMLS CUI [3]
C1739108
UMLS CUI [4,1]
C0030281
UMLS CUI [4,2]
C1948029
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C0021641
UMLS CUI [5,3]
C0456683
UMLS CUI [6,1]
C0342299
UMLS CUI [6,2]
C0445204
UMLS CUI [7]
C0474680
children and adolescents are not eligible to participate in the study.
Descripción

Children | Adolescents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2]
C0205653
pregnant women (or those who intend to become pregnant during the study period) and women who are currently breastfeeding are not eligible to participate.
Descripción

Pregnancy | Pregnancy, Planned | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
use of medications known to significantly increase body weight, such as chronic systemic steroids or certain psychiatric medications (e.g., lithium tricyclic antidepressants and anti-psychotic agents).
Descripción

Pharmaceutical Preparations Causing Weight Gain | Systemic steroids chronic | Lithium Tricyclic Antidepressive Agents | Antipsychotic Agents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0043094
UMLS CUI [2,1]
C2825233
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C3540800
UMLS CUI [3,2]
C0003290
UMLS CUI [4]
C0040615
non-ambulatory individuals, defined as those who are unable to walk at least one city block without a cane or walker.
Descripción

Unable to walk City block Quantity | Cane user | Walker user

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0560046
UMLS CUI [1,2]
C1706084
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0920240
UMLS CUI [3]
C0920121
any major illnesses that the surgical team believes present too great a risk for surgery. these include severe cardiac and pulmonary diseases, as well as uncontrolled type 2 diabetes.
Descripción

Illness Major Excludes Operative Surgical Procedures | Heart Diseases Severe | Lung diseases Severe | Type II diabetes mellitus uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0543467
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C2733146
evidence of major depression or other psychiatric disorder (schizophrenia, bipolar disorder, major depression, bulimia nervosa, etc.) that is uncontrolled, poorly controlled, or, in the opinion of the investigators, significantly interferes with daily living and functioning.
Descripción

Major Depressive Disorder Uncontrolled | Mental disorders Uncontrolled | Major Depressive Disorder Poorly controlled | Mental disorders Poorly controlled | Major Depressive Disorder Interferes with Activities of Daily Living | Mental disorder Interferes with Activities of Daily Living | Major Depressive Disorder Difficulty in daily functioning | Mental disorders Difficulty in daily functioning | Schizophrenia | Bipolar Disorder | Major Depressive Disorder | Bulimia Nervosa

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C1269683
UMLS CUI [3,2]
C3853134
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C3853134
UMLS CUI [5,1]
C1269683
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0001288
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0001288
UMLS CUI [7,1]
C1269683
UMLS CUI [7,2]
C4062591
UMLS CUI [8,1]
C0004936
UMLS CUI [8,2]
C4062591
UMLS CUI [9]
C0036341
UMLS CUI [10]
C0005586
UMLS CUI [11]
C1269683
UMLS CUI [12]
C2267227
any current (past 12 months) substance abuse or dependence disorder.
Descripción

Substance Use Disorders | Substance Dependence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
participants with moderate anemia (hgb < 12 mg/dl for men and hgb < 11 mg/dl for women)
Descripción

Anemia Moderate | Hemoglobin measurement | Gender

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0002871
UMLS CUI [1,2]
C0205081
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0079399
conditions that may falsely elevate or decrease hba1c values, including hemolytic or iron-deficiency anemia, hemoglobinopathies, and uremia.
Descripción

Condition Glycosylated haemoglobin increased False | Condition Glycosylated haemoglobin decreased False | Anemia, Hemolytic | Iron deficiency anemia | Hemoglobinopathies | Uremia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0239940
UMLS CUI [1,3]
C0205237
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0855304
UMLS CUI [2,3]
C0205237
UMLS CUI [3]
C0002878
UMLS CUI [4]
C0162316
UMLS CUI [5]
C0019045
UMLS CUI [6]
C0041948
abnormal laboratory tests which are clinically significant per the investigator.
Descripción

Laboratory test result abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438215
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Similar models

Eligibility Type 2 Diabetes NCT01040468

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
ages 18 to 65 years old.
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosis of type 2 diabetes.
boolean
C0011860 (UMLS CUI [1])
Body mass index
Item
individuals with a bmi of 30-40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Approval Bariatric Surgery
Item
approval for bariatric surgery (as confirmed by medical evaluation)
boolean
C0205540 (UMLS CUI [1,1])
C1456587 (UMLS CUI [1,2])
Insurance Coverage Bariatric Surgery
Item
insurance coverage for bariatric surgery
boolean
C0376629 (UMLS CUI [1,1])
C1456587 (UMLS CUI [1,2])
Change in diet Willing | Change Physical activity Willing | Change Body Weight Willing
Item
willingness to change diet, physical activity and weight.
boolean
C3671772 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0392747 (UMLS CUI [2,1])
C0026606 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
C0392747 (UMLS CUI [3,1])
C0005910 (UMLS CUI [3,2])
C0600109 (UMLS CUI [3,3])
Able to communicate Research Personnel | Competence Legal | Informed Consent
Item
ability to communicate with the investigator and be legally competent, provide written informed consent.
boolean
C2364293 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0086035 (UMLS CUI [2,1])
C1301860 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Maturity onset diabetes mellitus in young | Latent Autoimmune Diabetes in Adults | Beta Cell Destruction | Requirement Insulin U/day | Poor glycemic control Preoperative | Hemoglobin A1c measurement
Item
diagnosis of type 1 diabetes, diagnosis of maturity-onset diabetes of the young (mody), or latent autoimmune diabetes in adults (lada) (all of which are associated with ß-cell destruction), daily insulin requirements > 100 units, and poor preoperative glycemic control, as indicated by a hba1c > 6.5 - ≤ 8.5 or hba1c > 8.6 - < 9.5 (individuals with this hba1c value will require medical clearance and approval from the study physician).
boolean
C0011854 (UMLS CUI [1])
C0342276 (UMLS CUI [2])
C1739108 (UMLS CUI [3])
C0030281 (UMLS CUI [4,1])
C1948029 (UMLS CUI [4,2])
C1514873 (UMLS CUI [5,1])
C0021641 (UMLS CUI [5,2])
C0456683 (UMLS CUI [5,3])
C0342299 (UMLS CUI [6,1])
C0445204 (UMLS CUI [6,2])
C0474680 (UMLS CUI [7])
Children | Adolescents
Item
children and adolescents are not eligible to participate in the study.
boolean
C0008059 (UMLS CUI [1])
C0205653 (UMLS CUI [2])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
pregnant women (or those who intend to become pregnant during the study period) and women who are currently breastfeeding are not eligible to participate.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Pharmaceutical Preparations Causing Weight Gain | Systemic steroids chronic | Lithium Tricyclic Antidepressive Agents | Antipsychotic Agents
Item
use of medications known to significantly increase body weight, such as chronic systemic steroids or certain psychiatric medications (e.g., lithium tricyclic antidepressants and anti-psychotic agents).
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0043094 (UMLS CUI [1,3])
C2825233 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C3540800 (UMLS CUI [3,1])
C0003290 (UMLS CUI [3,2])
C0040615 (UMLS CUI [4])
Unable to walk City block Quantity | Cane user | Walker user
Item
non-ambulatory individuals, defined as those who are unable to walk at least one city block without a cane or walker.
boolean
C0560046 (UMLS CUI [1,1])
C1706084 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0920240 (UMLS CUI [2])
C0920121 (UMLS CUI [3])
Illness Major Excludes Operative Surgical Procedures | Heart Diseases Severe | Lung diseases Severe | Type II diabetes mellitus uncontrolled
Item
any major illnesses that the surgical team believes present too great a risk for surgery. these include severe cardiac and pulmonary diseases, as well as uncontrolled type 2 diabetes.
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
C0018799 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0024115 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C2733146 (UMLS CUI [4])
Major Depressive Disorder Uncontrolled | Mental disorders Uncontrolled | Major Depressive Disorder Poorly controlled | Mental disorders Poorly controlled | Major Depressive Disorder Interferes with Activities of Daily Living | Mental disorder Interferes with Activities of Daily Living | Major Depressive Disorder Difficulty in daily functioning | Mental disorders Difficulty in daily functioning | Schizophrenia | Bipolar Disorder | Major Depressive Disorder | Bulimia Nervosa
Item
evidence of major depression or other psychiatric disorder (schizophrenia, bipolar disorder, major depression, bulimia nervosa, etc.) that is uncontrolled, poorly controlled, or, in the opinion of the investigators, significantly interferes with daily living and functioning.
boolean
C1269683 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1269683 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C0004936 (UMLS CUI [4,1])
C3853134 (UMLS CUI [4,2])
C1269683 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0001288 (UMLS CUI [5,3])
C0004936 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0001288 (UMLS CUI [6,3])
C1269683 (UMLS CUI [7,1])
C4062591 (UMLS CUI [7,2])
C0004936 (UMLS CUI [8,1])
C4062591 (UMLS CUI [8,2])
C0036341 (UMLS CUI [9])
C0005586 (UMLS CUI [10])
C1269683 (UMLS CUI [11])
C2267227 (UMLS CUI [12])
Substance Use Disorders | Substance Dependence
Item
any current (past 12 months) substance abuse or dependence disorder.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Anemia Moderate | Hemoglobin measurement | Gender
Item
participants with moderate anemia (hgb < 12 mg/dl for men and hgb < 11 mg/dl for women)
boolean
C0002871 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Condition Glycosylated haemoglobin increased False | Condition Glycosylated haemoglobin decreased False | Anemia, Hemolytic | Iron deficiency anemia | Hemoglobinopathies | Uremia
Item
conditions that may falsely elevate or decrease hba1c values, including hemolytic or iron-deficiency anemia, hemoglobinopathies, and uremia.
boolean
C0348080 (UMLS CUI [1,1])
C0239940 (UMLS CUI [1,2])
C0205237 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0855304 (UMLS CUI [2,2])
C0205237 (UMLS CUI [2,3])
C0002878 (UMLS CUI [3])
C0162316 (UMLS CUI [4])
C0019045 (UMLS CUI [5])
C0041948 (UMLS CUI [6])
Laboratory test result abnormal
Item
abnormal laboratory tests which are clinically significant per the investigator.
boolean
C0438215 (UMLS CUI [1])
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