ID

15123

Beschrijving

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

Trefwoorden

  1. 17-05-16 17-05-16 -
Geüploaded op

17 mei 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Diabetes Mellitus, Type 2 NCT02256332

Eligibility Diabetes Mellitus, Type 2 NCT02256332

Inclusion Criteria
Beschrijving

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);
Beschrijving

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

Datatype

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;
Beschrijving

Age

Datatype

boolean

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

Body mass index

Datatype

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.
Beschrijving

Glycosylated hemoglobin A | Controlled by Diet Exercise

Datatype

boolean

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

Exclusion Criteria

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

Employee | Research Personnel

Datatype

boolean

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

Smoker chronic | Oral Tobacco chronic | Alcoholic Intoxication, Chronic

Datatype

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;
Beschrijving

Pharmaceutical Preparations | Vitamins | TONICS | Cholesterol

Datatype

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;
Beschrijving

Weight decreased | Weight Gain

Datatype

boolean

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

Food Allergy | Hypersensitivity Cosmetics

Datatype

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;
Beschrijving

Pregnancy | Pregnancy, Planned

Datatype

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.
Beschrijving

Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0006147

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02256332

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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