Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03120871 |
| Other study ID # |
16-2633 |
| Secondary ID |
UL1TR001082 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 12, 2017 |
| Est. completion date |
August 19, 2018 |
Study information
| Verified date |
October 2023 |
| Source |
University of Colorado, Denver |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The Microbiome Insulin Sensitivity Study "MISS" is a pilot study designed to study microbiome
composition across puberty and how it relates to insulin sensitivity and secretion in obese
girls, who are at increased risk for developing type 2 diabetes in puberty. The investigators
will evaluate the gut microbiome composition in fecal samples of 57 obese girls in three
groups: prepubertal (Tanner 1), early pubertal (Tanner 2-3), and late pubertal (Tanner 4-5).
Insulin sensitivity will also be measured via an intravenous glucose tolerance test (IVGTT)
in 18 prepubertal and late pubertal participants.
Description:
Pediatric type 2 diabetes (T2D) is increasing in prevalence and its incidence is twice as
high in girls as in boys. Pediatric onset of T2D occurs exclusively in obese youth and is
tightly linked with puberty, suggesting a link with the physiologic insulin resistance of
puberty. However, markers are as yet unavailable to identify those at highest risk for
progression to T2D. Results from the Treatment Options for Diabetes in Youth (TODAY) Study
demonstrate that pediatric T2D appears to progress rapidly in youth, forecasting poor quality
of life and early complications. Therefore, identifying those most at risk and developing a
better understanding of the pathophysiology of onset of T2D in youth are critical for
preventing T2D, particularly in obese girls.
The investigators overarching hypothesis is that effects of obesity on metabolic and hormonal
changes during puberty place obese girls at greatest risk for early T2D, similar to that
which is seen in women with gestational diabetes. More specifically, sex steroid effects on
insulin resistance, β-cell function, and body composition may contribute to both the pubertal
increase in risk for T2D, as well as the disproportionately higher prevalence of T2D among
girls. The investigators long-term goal is to design a focused intervention aimed to prevent
progression to T2D during puberty. In order to do this it is necessary to: 1. Develop a
better understanding of underlying mechanisms for β-cell failure in obese youth during
puberty, and 2. Identify early markers for predicting which obese youth will progress to
early T2D.
Alterations in gut microbiota appear to play an important role in mediating obesity and
insulin resistance through poorly understood mechanisms. Current hypotheses are that shifts
in the composition of the gut microbiome lead to dysregulation of complex polysaccharide
metabolism, altered production of gut hormones regulating energy balance, and local and
systemic inflammation. The gut microbiome composition has been reported to change during
pregnancy and may play a role in metabolic changes during this time. As metabolic and
hormonal changes in puberty parallel those in pregnancy, shifts in the microbiome may also
accompany metabolic shifts during puberty. Currently, there are no published studies
evaluating shifts in human gut microbiome composition during puberty. Consequently, the
overall goal of this study is to collect cross-sectional preliminary data to inform
feasibility of a future longitudinal study of metabolic and hormonal changes in lean and
obese youth during the pubertal transition.
