Phase 4
N=104
The Health Influences of Puberty (HIP) Study
Obesity · Insulin Resistance · Gonadal Dysfunction · Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01775813 ↗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
| Outcome | Result | p-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
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.