ID

15123

Description

Plant-based Ingredient on Post Prandial Glucose in Type II Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02256332

Link

https://clinicaltrials.gov/show/NCT02256332

Keywords

Versions (1)
  1. 5/17/16 5/17/16 -
Uploaded on

May 17, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02256332

English

Eligibility Diabetes Mellitus, Type 2 NCT02256332

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female volunteers with confirmed type ii diabetes not treated with pharmaceutical-based glucose lowering treatment for past three months (controlled solely through diet and exercise);
Description

Human Volunteers | Diabetes Mellitus, Non-Insulin-Dependent | Therapeutic procedure BLOOD GLUCOSE LOWERING DRUGS | Controlled by Diet Exercise

Data type

boolean

Alias
UMLS CUI [1]
C0020155
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C3653824
UMLS CUI [4,1]
C0332298
UMLS CUI [4,2]
C0012155
UMLS CUI [4,3]
C0015259
age ≥ 20 and ≤ 65 year at screening;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
body mass index (bmi) between ≥18 and ≤ 32 kg/m2;
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hba1c ≥48 mmol/mol and ≤53 mmol/mol (≥ 6.5% and ≤ 7.0%). at discretion of the study physician, subjects with hba1c >53 mmol/mol and <58 mmol/mol (>7.0% and < 7.5%) controlled solely through diet and exercise are also allowed to participate.
Description

Glycosylated hemoglobin A | Controlled by Diet Exercise

Data type

boolean

Alias
UMLS CUI [1]
C0019018
UMLS CUI [2,1]
C0332298
UMLS CUI [2,2]
C0012155
UMLS CUI [2,3]
C0015259
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
being an employee of unilever or research site;
Description

Employee | Research Personnel

Data type

boolean

Alias
UMLS CUI [1]
C0599987
UMLS CUI [2]
C0035173
chronic smokers, tobacco chewers and drinkers;
Description

Smoker chronic | Oral Tobacco chronic | Alcoholic Intoxication, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0337664
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0008038
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0001973
no medication, including vitamins and tonics, except for cholesterol, as determined by the physician;
Description

Pharmaceutical Preparations | Vitamins | TONICS | Cholesterol

Data type

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0042890
UMLS CUI [3]
C3543842
UMLS CUI [4]
C0008377
reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening;
Description

Weight decreased | Weight Gain

Data type

boolean

Alias
UMLS CUI [1]
C1262477
UMLS CUI [2]
C0043094
allergy to any food or cosmetics;
Description

Food Allergy | Hypersensitivity Cosmetics

Data type

boolean

Alias
UMLS CUI [1]
C0016470
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0010164
if female, not being pregnant or planning pregnancy during the study period;
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
if female, lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period.
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02256332

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Human Volunteers | Diabetes Mellitus, Non-Insulin-Dependent | Therapeutic procedure BLOOD GLUCOSE LOWERING DRUGS | Controlled by Diet Exercise
Item
male and female volunteers with confirmed type ii diabetes not treated with pharmaceutical-based glucose lowering treatment for past three months (controlled solely through diet and exercise);
boolean
C0020155 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C3653824 (UMLS CUI [3,2])
C0332298 (UMLS CUI [4,1])
C0012155 (UMLS CUI [4,2])
C0015259 (UMLS CUI [4,3])
Age
Item
age ≥ 20 and ≤ 65 year at screening;
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) between ≥18 and ≤ 32 kg/m2;
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A | Controlled by Diet Exercise
Item
hba1c ≥48 mmol/mol and ≤53 mmol/mol (≥ 6.5% and ≤ 7.0%). at discretion of the study physician, subjects with hba1c >53 mmol/mol and <58 mmol/mol (>7.0% and < 7.5%) controlled solely through diet and exercise are also allowed to participate.
boolean
C0019018 (UMLS CUI [1])
C0332298 (UMLS CUI [2,1])
C0012155 (UMLS CUI [2,2])
C0015259 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Employee | Research Personnel
Item
being an employee of unilever or research site;
boolean
C0599987 (UMLS CUI [1])
C0035173 (UMLS CUI [2])
Smoker chronic | Oral Tobacco chronic | Alcoholic Intoxication, Chronic
Item
chronic smokers, tobacco chewers and drinkers;
boolean
C0337664 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0008038 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0001973 (UMLS CUI [3])
Pharmaceutical Preparations | Vitamins | TONICS | Cholesterol
Item
no medication, including vitamins and tonics, except for cholesterol, as determined by the physician;
boolean
C0013227 (UMLS CUI [1])
C0042890 (UMLS CUI [2])
C3543842 (UMLS CUI [3])
C0008377 (UMLS CUI [4])
Weight decreased | Weight Gain
Item
reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening;
boolean
C1262477 (UMLS CUI [1])
C0043094 (UMLS CUI [2])
Food Allergy | Hypersensitivity Cosmetics
Item
allergy to any food or cosmetics;
boolean
C0016470 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0010164 (UMLS CUI [2,2])
Pregnancy | Pregnancy, Planned
Item
if female, not being pregnant or planning pregnancy during the study period;
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Breast Feeding
Item
if female, lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period.
boolean
C0006147 (UMLS CUI [1])
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