ID

12841

Description

Study of Metamucil on Blood Glucose and HbA1c in Type II NIDDM Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01582282

Link

https://clinicaltrials.gov/show/NCT01582282

Keywords

  1. 12/29/15 12/29/15 -
Uploaded on

December 29, 2015

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.

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 Non-Insulin-dependent Diabetes Mellitus NCT01582282

Eligibility Non-Insulin-dependent Diabetes Mellitus NCT01582282

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a clinical diagnosis of type ii diabetes mellitus, controlled by diet and/or second generation oral hypoglycemic drugs, with the onset of the disease after age 35.
Description

have a clinical diagnosis of type ii diabetes mellitus, controlled by diet and/or second generation oral hypoglycemic drugs, with the onset of the disease after age 35.

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0359086
UMLS CUI [4]
C0206132
are between 0 and 50% above "normal" body weight (adjusted by frame) according to the metropolitan life insurance tables
Description

are between 0 and 50% above "normal" body weight (adjusted by frame) according to the metropolitan life insurance tables

Data type

boolean

Alias
UMLS CUI [1]
C0005910
are male or female, aged 36-80 years with a diagnosis made at least 1 year prior to enrollment.
Description

are male or female, aged 36-80 years with a diagnosis made at least 1 year prior to enrollment.

Data type

boolean

Alias
UMLS CUI [1]
C0001779
have an hba1c level between 6 and 10%
Description

have an hba1c level between 6 and 10%

Data type

boolean

Alias
UMLS CUI [1]
C0019018
have a fasting serum glucose level between 120-220 mg/dl and not vary by more than ±20% during the month prior to entering the treatment phase and hba1c levels not vary by more than ±10% during the month prior to entering the treatment phase. serum glucose level must have been between 120-220mg/dl and the subject's hba1c between 6 and 10% at week 0.
Description

have a fasting serum glucose level between 120-220 mg/dl and not vary by more than ±20% during the month prior to entering the treatment phase and hba1c levels not vary by more than ±10% during the month prior to entering the treatment phase. serum glucose level must have been between 120-220mg/dl and the subject's hba1c between 6 and 10% at week 0.

Data type

boolean

Alias
UMLS CUI [1]
C0017725
UMLS CUI [2]
C0019018
have been on a "stable" diet consistent with ada-recommended dietary guidelines with intake of total dietary fiber < 15g/1000 calories and were willing to maintain this diet during the 20-week study.
Description

have been on a "stable" diet consistent with ada-recommended dietary guidelines with intake of total dietary fiber < 15g/1000 calories and were willing to maintain this diet during the 20-week study.

Data type

boolean

Alias
UMLS CUI [1]
C0012159
have maintained a constant body weight (±5%) during the month prior to entering the treatment phase
Description

have maintained a constant body weight (±5%) during the month prior to entering the treatment phase

Data type

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have a condition that would interfere with evaluation
Description

have a condition that would interfere with evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488

Similar models

Eligibility Non-Insulin-dependent Diabetes Mellitus NCT01582282

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
diabetes mellitus
Item
have a clinical diagnosis of type ii diabetes mellitus, controlled by diet and/or second generation oral hypoglycemic drugs, with the onset of the disease after age 35.
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0359086 (UMLS CUI [3])
C0206132 (UMLS CUI [4])
body weight
Item
are between 0 and 50% above "normal" body weight (adjusted by frame) according to the metropolitan life insurance tables
boolean
C0005910 (UMLS CUI [1])
age
Item
are male or female, aged 36-80 years with a diagnosis made at least 1 year prior to enrollment.
boolean
C0001779 (UMLS CUI [1])
HBA1c level
Item
have an hba1c level between 6 and 10%
boolean
C0019018 (UMLS CUI [1])
serum glucose level
Item
have a fasting serum glucose level between 120-220 mg/dl and not vary by more than ±20% during the month prior to entering the treatment phase and hba1c levels not vary by more than ±10% during the month prior to entering the treatment phase. serum glucose level must have been between 120-220mg/dl and the subject's hba1c between 6 and 10% at week 0.
boolean
C0017725 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
diet
Item
have been on a "stable" diet consistent with ada-recommended dietary guidelines with intake of total dietary fiber < 15g/1000 calories and were willing to maintain this diet during the 20-week study.
boolean
C0012159 (UMLS CUI [1])
constant body weight
Item
have maintained a constant body weight (±5%) during the month prior to entering the treatment phase
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
interfering condition
Item
have a condition that would interfere with evaluation
boolean
C0220825 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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