Disease: Hyperlipidemia, Diabetes
Protocol Title: Fructose-induced Hepatic De Novo Lipogenesis in Adolescents with Obesity
Principal Investigator: Lisa Hudgins, MD
Contact Information: Adaobi Onunkwo, Research Coordinator
646-962-8311 or email@example.com
Study Status: Open for enrollment
Brief Summary of Protocol: In the United States, fructose is a sugar consumed in large amounts.Dietary fructose has increased in parallel with the increase in obesity and may promote the development of diabetes and other chronic diseases by Americans. The largest source of dietary fructose is sweetened beverages that are consumed by adolescents more than any other age group. Fructose is rapidly taken up by the liver and changed into fats called triglycerides by a process called de novo lipogenesis (DNL). Over time, increased fat in the liver and bloodstream may increase the chances of diabetes and heart disease.
This protocol will compare the rates of DNL in two groups of obese adolescents - one with prediabetes and the other, metabolically healthy. We will test whether the pre-diabetic group will show greater DNL in response to fructose. This would support other evidence that increased fructose-induced hepatic DNL is an early mechanism linking dietary sugar to the adverse metabolic sequelae of obesity, including diabetes, fatty liver, dyslipidemia and coronary disease.
Potential candidates are males or females 12-21 years old, with a body mass index in the obese category, and no major illness or medications. Participants must be patients of NewYork-Presbyterian/Weill Cornell Medical Center. Detailed eligibility will be reviewed with the study team.
Participation includes two visits to the NewYork-Presbyterian/Weill Cornell Medical Center over a three month period. At visit one, a review of medical history, physical exam and blood tests will be performed. If qualified, volunteers will return within 3 months and have blood sampled through a small catheter in the arm to measure blood fats and glucose before and hourly for three hours after drinking a sweet beverage made with sugar.
Upon completion of the study, volunteers will receive a $75 gift card and a framed certificate of community service.
Treatment Overview (Potential Benefits): There is no guarantee that participants will receive direct benefit from this study. However, participation in this study may help others by increasing our knowledge of the mechanisms linked to diet that may cause and/or results from diabetes associated with obesity.
IRB Information: Weill Cornell Medical College IRB; Protocol #: 1804019121
The Rogosin Institute, Weill Cornell Medical College Clinical Translational Science Center and The University of Missouri-Columbia School of Medicine