ID

31236

Beschrijving

Effect of Short-Term Beta-Cell Rest in Adolescents and Young Adults With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00445627

Link

https://clinicaltrials.gov/show/NCT00445627

Trefwoorden

Versies (1)
  1. 31-07-18 31-07-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

31 juli 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Obesity NCT00445627

Engels

Eligibility Obesity NCT00445627

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00445627
Criteria
Beschrijving

Criteria

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. type 2 diabetes mellitus as defined by:
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
1. fasting blood glucose greater than or equal to 126 mg/dl or postprandial blood sugar greater than or equal to 200 mg/dl (either during ogtt at nih or as previously documented on outside medical record).
Beschrijving

Fasting blood glucose measurement | Blood glucose measurement Postprandial | Oral Glucose Tolerance Test

Datatype

boolean

Alias
UMLS CUI [1]
C0428568
UMLS CUI [2,1]
C0392201
UMLS CUI [2,2]
C0376674
UMLS CUI [3]
C0029161
2. since subjects may already have been started on treatment with hypoglycemic agents at the time of enrollment, they may have blood glucose levels in the impaired glucose tolerance range (fasting glucose 100-125 mg/dl and postprandial 140-199 mg/dl). this is a sign of adequately controlled diabetes, rather than an incorrect diagnosis of diabetes. therefore, prior documentation (on outside medical records) of blood glucose values documenting diabetes will be acceptable if the subject has impaired glucose tolerance rather than overt diabetes according to screening results at nih.
Beschrijving

Hypoglycemic Agents | Blood glucose measurement | Impaired glucose tolerance | Glucose measurement, fasting | Glucose measurement Postprandial

Datatype

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2]
C0392201
UMLS CUI [3]
C0271650
UMLS CUI [4]
C0202045
UMLS CUI [5,1]
C0337438
UMLS CUI [5,2]
C0376674
3. absence of insulin autoantibodies (in insulin na(sqrroot) ve patients only)
Beschrijving

Insulin autoantibody Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1275890
UMLS CUI [1,2]
C0332197
2. clinical diagnosis of type 1 diabetes mellitus (for pilot study only)
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
3. age 8-25 years at enrollment
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. normal ogtt at nih (fasting blood glucose < 100 mg/dl and 2 hour blood glucose < 140 mg/dl)
Beschrijving

Oral Glucose Tolerance Test Normal | Fasting blood glucose measurement | Blood glucose measurement Hour Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0029161
UMLS CUI [1,2]
C0205307
UMLS CUI [2]
C0428568
UMLS CUI [3,1]
C0392201
UMLS CUI [3,2]
C0439227
UMLS CUI [3,3]
C1265611
2. significant comorbidity that, in the opinion of the investigators, will increase risk to the subject(specific obesity-related comorbidities are explicitly permitted, including hypertension, hyperlipidemia, obstructive sleep apnea and non-alcoholic steatohepatitis)
Beschrijving

Comorbidity At risk Study Subject | Comorbidity Relationship Obesity allowed | Hypertensive disease allowed | Hyperlipidemia allowed | Obstructive Sleep Apnea allowed | Nonalcoholic Steatohepatitis allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0681850
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0028754
UMLS CUI [2,4]
C0683607
UMLS CUI [3,1]
C0020538
UMLS CUI [3,2]
C0683607
UMLS CUI [4,1]
C0020473
UMLS CUI [4,2]
C0683607
UMLS CUI [5,1]
C0520679
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C3241937
UMLS CUI [6,2]
C0683607
3. positive urine pregnancy test
Beschrijving

Urine pregnancy test positive

Datatype

boolean

Alias
UMLS CUI [1]
C0430059
4. psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to comply with study procedures
Beschrijving

Mental disorders Limiting Protocol Compliance | Cognition Disorders Limiting Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0009241
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0525058
non-diabetic controls:
Beschrijving

Control Groups Diabetes Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0011847
UMLS CUI [1,3]
C0332197
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
two types of volunteers will be recruited:
Beschrijving

Recruitment Volunteers Type Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C2949735
UMLS CUI [1,2]
C1997894
UMLS CUI [1,3]
C0332307
UMLS CUI [1,4]
C1265611
1. overweight and obese volunteers who will be bmi matched with study enrollees who have t2dm during analyses
Beschrijving

Overweight Volunteers | Volunteers Obese | Body mass index MATCHING Volunteers Non-Insulin-Dependent Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0497406
UMLS CUI [1,2]
C1997894
UMLS CUI [2,1]
C1997894
UMLS CUI [2,2]
C0028754
UMLS CUI [3,1]
C1305855
UMLS CUI [3,2]
C0150103
UMLS CUI [3,3]
C1997894
UMLS CUI [3,4]
C0011860
2. normal weight (bmi between 5th and 85th centiles for age) volunteers
Beschrijving

Volunteers Normal Body Weight | Body mass index

Datatype

boolean

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C0421272
UMLS CUI [2]
C1305855
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. diabetes
Beschrijving

Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0011849
2. significant comorbidity that, in the opinion of the investigators, will increase risk to the subject (specific obesity-related comorbidities are explicitly permitted, including hypertension, hyperlipidemia, obstructive sleep apnea and non-alcoholic steatohepatitis)
Beschrijving

Comorbidity At risk Study Subject | Comorbidity Relationship Obesity allowed | Hypertensive disease allowed | Hyperlipidemia allowed | Obstructive Sleep Apnea allowed | Nonalcoholic Steatohepatitis allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0681850
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0028754
UMLS CUI [2,4]
C0683607
UMLS CUI [3,1]
C0020538
UMLS CUI [3,2]
C0683607
UMLS CUI [4,1]
C0020473
UMLS CUI [4,2]
C0683607
UMLS CUI [5,1]
C0520679
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C3241937
UMLS CUI [6,2]
C0683607
3. current use of drugs that alter glucose metabolism (e.g. metformin)
Beschrijving

Pharmaceutical Preparations Changing Glucose metabolism | Metformin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0596620
UMLS CUI [2]
C0025598
4. current use of prescription or non-prescription weight-loss drugs
Beschrijving

Weight-Loss Agents | Weight-Loss Agents Non-Prescription

Datatype

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2,1]
C0376606
UMLS CUI [2,2]
C0013231
5. positive urine pregnancy test
Beschrijving

Urine pregnancy test positive

Datatype

boolean

Alias
UMLS CUI [1]
C0430059
6. psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to comply with study procedures
Beschrijving

Mental disorders Limiting Protocol Compliance | Cognition Disorders Limiting Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0009241
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0525058
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Similar models

Eligibility Obesity NCT00445627

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00445627
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
1. type 2 diabetes mellitus as defined by:
boolean
C0011860 (UMLS CUI [1])
Fasting blood glucose measurement | Blood glucose measurement Postprandial | Oral Glucose Tolerance Test
Item
1. fasting blood glucose greater than or equal to 126 mg/dl or postprandial blood sugar greater than or equal to 200 mg/dl (either during ogtt at nih or as previously documented on outside medical record).
boolean
C0428568 (UMLS CUI [1])
C0392201 (UMLS CUI [2,1])
C0376674 (UMLS CUI [2,2])
C0029161 (UMLS CUI [3])
Hypoglycemic Agents | Blood glucose measurement | Impaired glucose tolerance | Glucose measurement, fasting | Glucose measurement Postprandial
Item
2. since subjects may already have been started on treatment with hypoglycemic agents at the time of enrollment, they may have blood glucose levels in the impaired glucose tolerance range (fasting glucose 100-125 mg/dl and postprandial 140-199 mg/dl). this is a sign of adequately controlled diabetes, rather than an incorrect diagnosis of diabetes. therefore, prior documentation (on outside medical records) of blood glucose values documenting diabetes will be acceptable if the subject has impaired glucose tolerance rather than overt diabetes according to screening results at nih.
boolean
C0020616 (UMLS CUI [1])
C0392201 (UMLS CUI [2])
C0271650 (UMLS CUI [3])
C0202045 (UMLS CUI [4])
C0337438 (UMLS CUI [5,1])
C0376674 (UMLS CUI [5,2])
Insulin autoantibody Absent
Item
3. absence of insulin autoantibodies (in insulin na(sqrroot) ve patients only)
boolean
C1275890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
2. clinical diagnosis of type 1 diabetes mellitus (for pilot study only)
boolean
C0011854 (UMLS CUI [1])
Age
Item
3. age 8-25 years at enrollment
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Oral Glucose Tolerance Test Normal | Fasting blood glucose measurement | Blood glucose measurement Hour Quantity
Item
1. normal ogtt at nih (fasting blood glucose < 100 mg/dl and 2 hour blood glucose < 140 mg/dl)
boolean
C0029161 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0428568 (UMLS CUI [2])
C0392201 (UMLS CUI [3,1])
C0439227 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Comorbidity At risk Study Subject | Comorbidity Relationship Obesity allowed | Hypertensive disease allowed | Hyperlipidemia allowed | Obstructive Sleep Apnea allowed | Nonalcoholic Steatohepatitis allowed
Item
2. significant comorbidity that, in the opinion of the investigators, will increase risk to the subject(specific obesity-related comorbidities are explicitly permitted, including hypertension, hyperlipidemia, obstructive sleep apnea and non-alcoholic steatohepatitis)
boolean
C0009488 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0028754 (UMLS CUI [2,3])
C0683607 (UMLS CUI [2,4])
C0020538 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0020473 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0520679 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C3241937 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
Urine pregnancy test positive
Item
3. positive urine pregnancy test
boolean
C0430059 (UMLS CUI [1])
Mental disorders Limiting Protocol Compliance | Cognition Disorders Limiting Protocol Compliance
Item
4. psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to comply with study procedures
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0009241 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Control Groups Diabetes Absent
Item
non-diabetic controls:
boolean
C0009932 (UMLS CUI [1,1])
C0011847 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C1512693 (UMLS CUI)
Recruitment Volunteers Type Quantity
Item
two types of volunteers will be recruited:
boolean
C2949735 (UMLS CUI [1,1])
C1997894 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Overweight Volunteers | Volunteers Obese | Body mass index MATCHING Volunteers Non-Insulin-Dependent Diabetes Mellitus
Item
1. overweight and obese volunteers who will be bmi matched with study enrollees who have t2dm during analyses
boolean
C0497406 (UMLS CUI [1,1])
C1997894 (UMLS CUI [1,2])
C1997894 (UMLS CUI [2,1])
C0028754 (UMLS CUI [2,2])
C1305855 (UMLS CUI [3,1])
C0150103 (UMLS CUI [3,2])
C1997894 (UMLS CUI [3,3])
C0011860 (UMLS CUI [3,4])
Volunteers Normal Body Weight | Body mass index
Item
2. normal weight (bmi between 5th and 85th centiles for age) volunteers
boolean
C1997894 (UMLS CUI [1,1])
C0421272 (UMLS CUI [1,2])
C1305855 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus
Item
1. diabetes
boolean
C0011849 (UMLS CUI [1])
Comorbidity At risk Study Subject | Comorbidity Relationship Obesity allowed | Hypertensive disease allowed | Hyperlipidemia allowed | Obstructive Sleep Apnea allowed | Nonalcoholic Steatohepatitis allowed
Item
2. significant comorbidity that, in the opinion of the investigators, will increase risk to the subject (specific obesity-related comorbidities are explicitly permitted, including hypertension, hyperlipidemia, obstructive sleep apnea and non-alcoholic steatohepatitis)
boolean
C0009488 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0028754 (UMLS CUI [2,3])
C0683607 (UMLS CUI [2,4])
C0020538 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0020473 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0520679 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C3241937 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
Pharmaceutical Preparations Changing Glucose metabolism | Metformin
Item
3. current use of drugs that alter glucose metabolism (e.g. metformin)
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2])
Weight-Loss Agents | Weight-Loss Agents Non-Prescription
Item
4. current use of prescription or non-prescription weight-loss drugs
boolean
C0376606 (UMLS CUI [1])
C0376606 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
Urine pregnancy test positive
Item
5. positive urine pregnancy test
boolean
C0430059 (UMLS CUI [1])
Mental disorders Limiting Protocol Compliance | Cognition Disorders Limiting Protocol Compliance
Item
6. psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to comply with study procedures
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0009241 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
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