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

Versions (1)
  1. 12/29/15 12/29/15 -
Uploaded on

December 29, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Insulin-dependent Diabetes Mellitus NCT01582282

English

Eligibility Non-Insulin-dependent Diabetes Mellitus NCT01582282

1 forms  
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
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Similar models

Eligibility Non-Insulin-dependent Diabetes Mellitus NCT01582282

1 forms
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])
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