The Health Influences of Puberty (HIP) Study (HIP)
Obesity, Insulin Resistance, Gonadal Dysfunction
About this trial
This is an interventional prevention trial for Obesity focused on measuring Insulin resistance, Puberty, Obesity, Hypogonadism, Gonadal dysfunction, Metformin
Eligibility Criteria
Inclusion Criteria:
- BMI ≥ 95th percentile
- At least Tanner 2, but no more than Tanner 3
- Age ≥ 9 years
- Absence of impaired glucose tolerance (IGT), impaired fasting glucose (IFG) or Type 2 diabetes mellitus (T2DM)
Exclusion Criteria:
- Presence of T2DM, IGT or IFG
- Any disorder or medication known to effect glucose tolerance;
- Hypertension or hyperlipidemia requiring pharmacological intervention;
- Weight >300lbs. due to limits of imaging tables.
- Chronic illness
Sites / Locations
- Children's Hospital Colorado
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
No Intervention
No Intervention
Obese metformin arm
Obese placebo arm
Obese - NT
Normal weight
Double-blinded placebo-controlled trial of metformin during puberty, treatment arm Dosage form: Metformin 1000 mg tablets Dosage: 1000 mg by mouth twice daily Duration: From early puberty (Tanner 2-3) until puberty completion (Tanner 5), approximately 3 years
Double-blinded placebo-controlled trial of metformin during puberty, placebo arm Dosage form: Placebo stamped to match 1000 mg metformin tablets Placebo comparator: Stamped placebo pill matching metformin dose Dosage: 1000 mg by mouth twice daily Duration: From early puberty (Tanner 2-3) until puberty completion (Tanner 5), approximately 3 years
Comparator group for the observational comparison of metabolic changes in youth with normal weight and obesity as they progress through puberty. Duration: From early puberty (Tanner 2-3) until puberty completion (Tanner 5), approximately 3 years
Comparator group for the observational comparison of metabolic changes in youth with normal weight and obesity as they progress through puberty. Duration: From early puberty (Tanner 2-3) until puberty completion (Tanner 5), approximately 3 years