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NCT01775813 · ClinicalTrials.gov registry record · Phase 4
The Health Influences of Puberty (HIP) Study
A Phase 4 study of Obesity and Type 2 Diabetes, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 104
- Enrollment target
- 1
- Study location
NCT01775813: Completed Phase 4 study of Obesity and Type 2 Diabetes, sponsored by University of Colorado, Denver.
NCT01775813 is a Phase 4 study of Obesity and Type 2 Diabetes that has completed, run by University of Colorado, Denver. The registered enrollment target is 104 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01775813, a Phase 4 study of Obesity and Type 2 Diabetes, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 104 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
As measured by in intravenous glucose tolerance test (IVGTT) as calculated by Bergman's minimal model. Higher numbers indicate a better outcome. Patients are randomized to receive metformin or placebo at Tanner stage 2-3 of puberty. They are reassessed at Tanner 4 and again at Tanner 5. At that point, the treatment is stopped and they are reassessed 6 months after stopping treatment to see if effects of treatment persist.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Metformin
Study Locations (1)
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2011-06 |
| Est. Completion | 2018-05-31 |
| Phase | Phase 4 |
What the finished NCT01775813 record still lists
NCT01775813 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (87% lower).
The record links to 4 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01775813 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT01775813 about?
NCT01775813 is a clinical study titled "The Health Influences of Puberty (HIP) Study". 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 puber...
What is the current status of trial NCT01775813?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 104 participants. The study started on 2011-06. Estimated completion is 2018-05-31.
What conditions does trial NCT01775813 study?
This clinical trial studies the following conditions: Obesity, Type 2 Diabetes, Insulin Resistance, Gonadal Dysfunction.
What interventions are being tested in trial NCT01775813?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG).
Who is sponsoring clinical trial NCT01775813?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01775813 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01775813's enrollment target sits among peer trials
104 468th of 1053 higher than 585 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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