ID

13109

Description

Health Effects of Liposuction in Overweight Women With Elevated Insulin Levels, Impaired Glucose Tolerance and/or Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00005760

Link

https://clinicaltrials.gov/show/NCT00005760

Keywords

Versions (1)
  1. 1/17/16 1/17/16 -
Uploaded on

January 17, 2016

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 Glucose Intolerance NCT00005760

English

Eligibility Glucose Intolerance NCT00005760

1 forms  
Criteria
Description

Criteria

obesity: defined as subjects having a body mass index greater than 30 kg/m(2). weight must be less than 300 lb (136 kg) because of limits related to the dxa and ct scanners.
Description

bmi, body weight

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
patients with type 2 diabetes, impaired glucose tolerance, or hyperinsulinemia are eligible.
Description

type 2 diabetes, impaired glucose tolerance, hyperinsulinemia

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0020459
UMLS CUI [3]
C0271650
patients' age must be greater than or equal to 18 years at the start of the study.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must be planning to undergo large volume liposuction.
Description

liposuction

Data type

boolean

Alias
UMLS CUI [1]
C0038640
premenopausal women participating in the study must have a negative pregnancy test at the start of the study and will be required to remain on some form of effective contraception for the duration of the study.
Description

pregnancy test, contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032976
UMLS CUI [2]
C0700589
patients recruited for the pilot study will be required to have all four grandparents and both parents to be either all non-hispanic caucasians or non-hispanic african-american.
Description

race

Data type

boolean

Alias
UMLS CUI [1]
C0034510
volunteers with the presence of significant, unstable or evolving renal disease are not eligible. subjects must not have calculated (age and weight corrected) creatinine clearances below 50 ml/min or significant worsening of serum creatinine levels during the course of the study (greater than 30% increase from baseline).
Description

renal disease, creatinine clearance, serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0373595
UMLS CUI [3]
C0201976
volunteers with the presence of significant, unstable or evolving hepatic disease associated with sgot and/or sgpt greater than 2.5 times normal are not eligible.
Description

ast, alt

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
volunteers with the presence of significant, evolving or unstable cardiac disease are not eligible. subjects with nyha stage 3 or 4 disease will be excluded from the study.
Description

heart disease, nyha

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C1275491
volunteers with the presence of significant, evolving or unstable pulmonary disease including uncontrolled bronchial asthma and/or chronic bronchitis are not eligible.
Description

pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C0024115
volunteers with the presence of other uncontrolled or unstable medical conditions including uncontrolled thyroid disease, cushing's syndrome, autoimmune or gastrointestinal disease are not eligible.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
volunteers who are pregnant are not eligible.
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
volunteers must not have uncontrolled type 2 diabetes as evidenced by recent coma or pre-coma states, frequent episodes of hypoglycemia, predominantly severe hyperglycemia (plasma glucose greater than 400 mg/dl) in the past three months prior to study commencement, a glycosylated hemoglobin (hba1c) value greater than 10 in the past three months prior to the study commencement, and frequent or recurrent episodes of ketosis (ketonuria and/or ketonemia).
Description

type 2 diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011860
volunteers with uncontrolled, significant or evolving psychiatric/psychological syndromes which in the opinion of the investigators would place the patient at increased risk during the course of the study or would impede competence and/or ability to complete the study are not eligible.
Description

mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0004936
volunteers with current history of illicit substance abuse and/or alcoholism based on reported history and the cage questionnaire are not eligible.
Description

substance abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
volunteers must not have a recent use (within the preceding 6 months) of anorexiant medications or medications that would affect nutrient absorption such as orlistat or acarbose.
Description

medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
volunteers must not be receiving treatment with an insulin-sensitizing medication such as metformin or the thiazolidinediones. use of insulin, meglitides or the sulphonylureas will not constitute an exclusion.
Description

medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
volunteers with an absence of spontaneous menses for greater than 1 year are not eligible.
Description

menstruation

Data type

boolean

Alias
UMLS CUI [1]
C0025344
Back to the top of the page

Similar models

Eligibility Glucose Intolerance NCT00005760

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
bmi, body weight
Item
obesity: defined as subjects having a body mass index greater than 30 kg/m(2). weight must be less than 300 lb (136 kg) because of limits related to the dxa and ct scanners.
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
type 2 diabetes, impaired glucose tolerance, hyperinsulinemia
Item
patients with type 2 diabetes, impaired glucose tolerance, or hyperinsulinemia are eligible.
boolean
C0011860 (UMLS CUI [1])
C0020459 (UMLS CUI [2])
C0271650 (UMLS CUI [3])
age
Item
patients' age must be greater than or equal to 18 years at the start of the study.
boolean
C0001779 (UMLS CUI [1])
liposuction
Item
patients must be planning to undergo large volume liposuction.
boolean
C0038640 (UMLS CUI [1])
pregnancy test, contraception
Item
premenopausal women participating in the study must have a negative pregnancy test at the start of the study and will be required to remain on some form of effective contraception for the duration of the study.
boolean
C0032976 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
race
Item
patients recruited for the pilot study will be required to have all four grandparents and both parents to be either all non-hispanic caucasians or non-hispanic african-american.
boolean
C0034510 (UMLS CUI [1])
renal disease, creatinine clearance, serum creatinine
Item
volunteers with the presence of significant, unstable or evolving renal disease are not eligible. subjects must not have calculated (age and weight corrected) creatinine clearances below 50 ml/min or significant worsening of serum creatinine levels during the course of the study (greater than 30% increase from baseline).
boolean
C0022658 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
ast, alt
Item
volunteers with the presence of significant, unstable or evolving hepatic disease associated with sgot and/or sgpt greater than 2.5 times normal are not eligible.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
heart disease, nyha
Item
volunteers with the presence of significant, evolving or unstable cardiac disease are not eligible. subjects with nyha stage 3 or 4 disease will be excluded from the study.
boolean
C0018799 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
pulmonary disease
Item
volunteers with the presence of significant, evolving or unstable pulmonary disease including uncontrolled bronchial asthma and/or chronic bronchitis are not eligible.
boolean
C0024115 (UMLS CUI [1])
comorbidity
Item
volunteers with the presence of other uncontrolled or unstable medical conditions including uncontrolled thyroid disease, cushing's syndrome, autoimmune or gastrointestinal disease are not eligible.
boolean
C0009488 (UMLS CUI [1])
pregnancy
Item
volunteers who are pregnant are not eligible.
boolean
C0032961 (UMLS CUI [1])
type 2 diabetes
Item
volunteers must not have uncontrolled type 2 diabetes as evidenced by recent coma or pre-coma states, frequent episodes of hypoglycemia, predominantly severe hyperglycemia (plasma glucose greater than 400 mg/dl) in the past three months prior to study commencement, a glycosylated hemoglobin (hba1c) value greater than 10 in the past three months prior to the study commencement, and frequent or recurrent episodes of ketosis (ketonuria and/or ketonemia).
boolean
C0011860 (UMLS CUI [1])
mental disorders
Item
volunteers with uncontrolled, significant or evolving psychiatric/psychological syndromes which in the opinion of the investigators would place the patient at increased risk during the course of the study or would impede competence and/or ability to complete the study are not eligible.
boolean
C0004936 (UMLS CUI [1])
substance abuse
Item
volunteers with current history of illicit substance abuse and/or alcoholism based on reported history and the cage questionnaire are not eligible.
boolean
C0038586 (UMLS CUI [1])
medication
Item
volunteers must not have a recent use (within the preceding 6 months) of anorexiant medications or medications that would affect nutrient absorption such as orlistat or acarbose.
boolean
C0013227 (UMLS CUI [1])
medication
Item
volunteers must not be receiving treatment with an insulin-sensitizing medication such as metformin or the thiazolidinediones. use of insulin, meglitides or the sulphonylureas will not constitute an exclusion.
boolean
C0013227 (UMLS CUI [1])
menstruation
Item
volunteers with an absence of spontaneous menses for greater than 1 year are not eligible.
boolean
C0025344 (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