At a glance
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Assessment of Hepatic Glucose and Fat Regulation in Overweight Adolescent Girls
In Brief
A Phase 3 clinical trial evaluating Byetta 5Mcg Pen Injection for Hepatic Steatosis and 2 related conditions. Completed, enrolled 92 participants across 1 site.
Detailed Summary
Women with polycystic ovarian syndrome (PCOS) have increased rates of hepatic steatosis compared to weight similar women with regular menses. It is unclear if this is related to high testosterone or insulin resistance. The investigators will assess hepatic glucose release, rates of lipolysis and hepatic de novo lipogenesis in the fasted and postprandial state to determine if alterations in the processes contribute to hepatic steatosis. Participants will be overweight, sedentary girls with or without PCOS. Those with PCOS will either be medication naive, or must be taking metformin or combined oral contraceptives (COCPs) for a period of at least 6 months prior to study procedures.
Study Details
Timeline
Interventions
10 participants will receive 2 doses of Byetta, one at 7 PM the night prior to metabolic study and the second 30 min before ingestion of glucola