Age
Item
13 to <18 years of age
boolean
C0001779 (UMLS CUI [1])
BMI
Item
bmi considered overweight (bmi > 25 kg/m2 ) or obese (bmi > 30 kg/m2 )
boolean
C1305855 (UMLS CUI [1])
Hepatic steatosis
Item
confirmed 1h-mrs defined hepatic steatosis (>5.5% fat/water)
boolean
C2711227 (UMLS CUI [1,1])
C3850002 (UMLS CUI [1,2])
Informed consent by guardian and patient
Item
parent/guardian willing and able to provide written, signed informed consent, and subjects willing to co-sign parental consent
boolean
C0021430 (UMLS CUI [1,1])
C1274041 (UMLS CUI [1,2])
C0514052 (UMLS CUI [2,1])
C0026193 (UMLS CUI [2,2])
Willing to use contraception
Item
sexually active subjects must be willing to use an acceptable method of contraception
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Pregnancy test
Item
females of child bearing potential must have a negative pregnancy test at screening.
boolean
C0427780 (UMLS CUI [1])
Concomitant medication except natural health products or contraception
Item
the use of any chronic medications with the exception of oral birth control and natural health products with the exception of multivitamins.
boolean
C0240320 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0205296 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C1705847 (UMLS CUI [3,4])
C3653317 (UMLS CUI [3,5])
Insulin snesitivity and altered tissue lipid content
Item
adolescents with altered insulin sensitivity or tissue lipid content unrelated to obesity and the metabolic syndrome, including:
boolean
C0920563 (UMLS CUI [1])
C0424619 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0028754 (UMLS CUI [2,3])
Comorbidity
Item
type 2 diabetes; present or previous malignancy, renal disease, hypertension (anyone who has bps over the 99th percentile for age and gender) or liver disease;
boolean
C0011860 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0006826 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
Recent weight loss or participation in weight loss program
Item
significant weight loss (10% in last six months) or enrolled in weight loss program in the six months prior to the study;
boolean
C1262477 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C3179079 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Alcohol consumption
Item
self-reported history of alcohol consumption of greater than two drinks per day and/or drinking alcohol more than once weekly;
boolean
C0001948 (UMLS CUI [1])
Drug use
Item
report using non-prescription recreational drugs;
boolean
C0242508 (UMLS CUI [1])
Hypersensitivities to drug ingredients
Item
allergies or sensitivities to any of the ingredients in the investigational product or placebo;
boolean
C0020517 (UMLS CUI [1,1])
C1550600 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1550600 (UMLS CUI [2,2])
C0032042 (UMLS CUI [2,3])
Pregnancy or breastfeeding
Item
females breastfeeding at screening or planning on becoming pregnant at any time during the study;
boolean
C0006147 (UMLS CUI [1])
C0032992 (UMLS CUI [2])