Healthy male or female adolescents, age 12 to 17 years (inclusive) at Screening, with a body mass index (BMI) that is greater than or equal to the United States-weighted mean of the 95th percentile based on age and sex with a body weight greater than 60 kilograms (kg). Participants with Type 2 diabetes mellitus (T2DM) may have a pre-existing or new diagnosis of T2DM.
HbA1c =6.5%
fasting plasma glucose (FPG) =126 mg/dL (7.0 mmol/L)
Participants and their families not planning to move away from the area for the duration of the study
Participants able and willing to comply with all aspects of the study, including a standardized, reduced calorie diet and an age appropriate, increased physical activity program
Participants considered in stable health in the opinion of the investigator
Able and willing to support and supervise study participation in the opinion of the investigator, including consideration of any existing physical, medical, or mental condition that prevents compliance with the protocol
Able and willing to personally comply with and execute all aspects of the study requirements for the caregivers or guardians

NCT03338296_inc_T1
Condition
Healthy
NCT03338296_inc_T2
Person
male
NCT03338296_inc_T3
Person
female
NCT03338296_inc_T4
Person
adolescents
NCT03338296_inc_T5
Person
age
NCT03338296_inc_T6
Value
12 to 17 years
NCT03338296_inc_T7
Temporal
at Screening
NCT03338296_inc_T8
Measurement
body mass index (BMI)
NCT03338296_inc_T9
Value
greater than or equal to the United States-weighted mean of the 95th percentile
NCT03338296_inc_T10
Qualifier
based on age
NCT03338296_inc_T11
Qualifier
based on sex
NCT03338296_inc_T12
Measurement
body weight
NCT03338296_inc_T13
Value
greater than 60 kilograms (kg)
NCT03338296_inc_T14
Value
greater than or equal to the 95th percentile
NCT03338296_inc_T15
Scope
based on age and sex
NCT03338296_inc_T17
Measurement
HbA1c
NCT03338296_inc_T18
Value
=6.5%
NCT03338296_inc_T19
Measurement
fasting plasma glucose (FPG)
NCT03338296_inc_T20
Value
=126 mg/dL
NCT03338296_inc_T21
Value
7.0 mmol/L
NCT03338296_inc_T22
Negation
not
NCT03338296_inc_T23
Observation
planning to move away
NCT03338296_inc_T24
Temporal
for the duration of the study
NCT03338296_inc_T25
Reference_point
the study
NCT03338296_inc_T26
Observation
willing to comply
NCT03338296_inc_T27
Observation
 an omply wit
NCT03338296_inc_T28
Observation
reduced calorie diet
NCT03338296_inc_T29
Qualifier
standardized
NCT03338296_inc_T30
Observation
increased physical activity program
NCT03338296_inc_T31
Scope
standardized, reduced calorie diet and an age appropriate, increased physical activity program
NCT03338296_inc_T32
Qualifier
age appropriate
NCT03338296_inc_T33
Scope
able and willing to comply
NCT03338296_inc_T34
Observation
stable health
NCT03338296_inc_T37
Observation
willing to personally comply
NCT03338296_inc_T38
Observation
d wi onally comply with a
NCT03338296_inc_T39
Person
caregivers
NCT03338296_inc_T40
Person
guardians
NCT03338296_inc_T41
Scope
caregivers or guardians
NCT03338296_inc_T42
Scope
Able and willing to personally comply