Study of Serum Markers for Cardiovascular Risk in Obese Youth and Impact of Lifestyle and Medication Intervention
Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
In Protocol #2, we will select 30 obese pubertal and 30 obese prepubertal subjects with an
abnormal cytokine profile (i.e. fibrinogen and/or hsCRP concentration greater than or equal
to 2 Standard Deviations (SD) above the mean established in our lab for lean controls in
Protocol #1). They will be randomly assigned to either lifestyle intervention (diet/exercise)
or diet/exercise plus metformin for 6 months. After the 6 month evaluation the subjects will
cross over the treatment arms, i.e., those that were doing diet/exercise intervention only
will add metformin, those that were doing the diet/exercise plus metformin will discontinue
the metformin and continue with diet/exercise changes only. Intrahepatic fat contents will be
measured as well.
The investigators hypothesize that obese children in these age groups will have increased
cardiovascular risk related to their obese state before reaching the currently defined
criteria of metabolic syndrome.
The investigators hypothesize that these cardiovascular risks can be reduced with lifestyle
and drug interventions.