NCT02157974

Liver and Fat Regulation in Overweight Adolescent Girls

Assessment of Hepatic Glucose and Fat Regulation in Overweight Adolescent Girls

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 12 Years – 21 Years
• Healthy volunteers: Accepted

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.

Detailed description

Hepatic glucose release will be assessed with a stable isotope glycerol tracer, lipolysis with a glycerol tracer, and hepatic de novo lipogenesis with an acetate tracer. Data will be collected fasting and after a glucose challenge. The degree of hepatic steatosis and abdominal fat partitioning will be assessed with Magnetic Resonance Imaging (MRI), and total body composition with Dual-energy X-ray absorptiometry (DEXA).

Conditions

• Hepatic Steatosis
• Polycystic Ovarian Syndrome
• Obesity

Interventions

Type	Name	Description
DRUG	Byetta 5Mcg Pen Injection	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

Timeline

• Start date: 2014-08-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2014-06-06
• Last updated: 2024-06-04
• Results posted: 2024-06-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study