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Phase 4 N=104 Randomized Quadruple-blind Prevention

The Health Influences of Puberty (HIP) Study

Obesity · Insulin Resistance · Gonadal Dysfunction · Type 2 Diabetes

Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Insulin Sensitivity — 8.559; 3.425; 3.756; 2.985 x10-4/min-1/mIU/mL

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Metformin (Drug); Placebo (Drug)
Age
Pediatric · 9+ yrs
Sex
All
Sponsor
University of Colorado, Denver
Primary completion
May 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Insulin Sensitivity
8.559; 3.425; 3.756; 2.985; 6.661; 1.995
SECONDARY
Insulin Secretion (Acute Insulin Response to Glucose, AIRg)
583.535; 1877.895; 1858.16; 2368.931; 783.191; 1951.323
SECONDARY
Disposition Index
3750.463; 4195.921; 4286.209; 4438.821; 3706.940; 3269.039
SECONDARY
Low Density Lipoprotein
79.488; 86.533; 88.583; 83.779; 75.367; 96.636
SECONDARY
Insulin-like Growth Factor 1
313.500; 262.278; 243.042; 281.700; 405.389; 370.800
SECONDARY
Total Testosterone
108.625; 35.278; 30.125; 41.050; 145.972; 87.933
SECONDARY
Estradiol
22.375; 15.722; 15.833; 14.750; 50.583; 35.867
SECONDARY
Sex Hormone Binding Globulin
61.958; 20.417; 18.958; 17.550; 50.417; 17.200
SECONDARY
Dehydroepiandrosterone Sulfate
90.146; 96.750; 91.167; 107.600; 101.889; 101.533
SECONDARY
High Sensitivity C-reactive Protein
1.001; 2.523; 3.117; 3.962; 0.305; 4.530
SECONDARY
Aspartate Aminotransferase (AST)
42.174; 41.250; 43.542; 54.150; 35.706; 44.429
SECONDARY
Alanine Transaminase (ALT)
25.022; 35.194; 41.125; 52.400; 27.059; 44.571
SECONDARY
Change in Urinary Luteinizing Hormone
3.849; 2.257; 2.257; 3.809; 4.518; 3.310
SECONDARY
Change in Urinary Follicle-stimulating Hormone
3.911; 3.837; 3.837; 3.615; 2.555; 4.874
SECONDARY
Change in Urinary Estradiol Metabolites
7.711; 17.353; 17.353; 28.451; 22.919; 8.584
SECONDARY
Hemoglobin A1c
5.139; 5.336; 5.336; 5.400; 5.200; 5.627
SECONDARY
Leptin
5.956; 32.097; 33.917; 32.215; 5.964; 36.867
SECONDARY
Percent Body Fat
24.883; 42.126; 44.700; 43.826; 25.054; 43.380
SECONDARY
Visceral Adipose
7.647; 12.007; 12.076; 12.007; 6.322; 12.236
SECONDARY
Liver Adipose
1.376; 8.290; 13.765; 8.290; 2.208; 8.219
SECONDARY
High Density Lipoprotein
51.442; 39.306; 38.917; 41.368; 51.667; 39.455

Summary

The Health Influences of Puberty (HIP) Study is designed to explore the relationships between puberty and the onset of type 2 diabetes in adolescents. The results of this study will help us better understand how to prevent type 2 diabetes in these youth. Children go through many changes during puberty, including important hormonal and behavioral alterations. Among these changes, it has long been known that, during puberty, insulin does not work as well as it does before and after puberty. This is called physiologic insulin resistance. In healthy children, this does not cause diabetes or affect blood sugar in any way because the body is able to compensate by making more insulin. Indeed, this is thought to be an important part of the adolescent growth spurt. However, in some children with increased risk for developing type 2 diabetes due to obesity and genetics, the worsening insulin resistance of puberty cannot be compensated for and these youth get diabetes early. The investigators believe this is because type 2 diabetes is rarely, if ever, seen before puberty begins, and the peak of diabetes onset in adolescents occurs at the time of the worst insulin resistance. This specific research project has two goals: 1. To examine effects of obesity on how well the body's insulin works during puberty, and 2. To see if treatment of obese children during this critical period of puberty with a medication that improves insulin resistance (metformin) will help prevent early onset type 2 diabetes.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01775813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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