Endocrinology

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Participation in Our Research

Published On 07/11/2011

Research into the causes of diseases is essential to advance future clinical care.  Our Division of Pediatric Endocrinology and Metabolism continues to lead internationally-recognized research in hormonal disorders such as diabetes and growth hormone deficiency.  Our site currently hosts active clinical trials. 

Infants, Children, Adolescents and Research Studies

Too often, the medicines, medical devices and other therapies administered to minors have only been tested in adults, then scaled down by weight.  The label approved for the therapy by the FDA will not include younger people if studies were not performed with infants, children or adolescents.  Although the “off label” approach of giving therapies to pediatric patients usually works acceptably, sometimes drugs and treatments are not optimized for effectiveness and safety in minors.  That is why research in pediatrics is so important.  The National Institutes of Health has put together an informative Web site for parents and kids to learn more about pediatric research.  To learn more, click here.

Active Research here in Memphis at the Le Bonheur and University of Tennessee Health Science Center Division of Pediatric Endocrinology and Metabolism

We invite you to read the complete list below of the studies active here in Memphis.  Instructions are included for inquiries about participating in this research.  Your family’s participation in one of these studies may lead to improved understanding of disease and improved therapies for other patients with hormonal and metabolic disorders.

For more information about participating in any of our research studies, please contact our Clinical Research Coordinator, Dana McCommon, RN at 901.287.5926 or by email, mccommod@lebonheur.org.

 

Actively Recruiting: Eli Lilly & Co.’s H8O-MC-GWBQ Study for Type 2 Diabetes Mellitus

This clinical trial enrolls participants recently diagnosed with type 2 diabetes who are between ages 10 to 16 years. This study evaluates the safety and efficacy of Byetta® (exenatide) as monotherapy and adjunctive therapy with oral anti-diabetic agents for adolescents with type 2 diabetes. The study lasts approximately 28 weeks and is conducted as an out-patient.

 

Actively Recruiting: Novo Nordisk’s NN2211-1800 Study for Type 2 Diabetes Mellitus

This clinical trial enrolls participants diagnosed with type 2 diabetes who are between ages 10 to 45 years. This study evaluates the safety and efficacy of liraglutide as monotherapy and adjunctive therapy with oral anti-diabetic agents to treat type 2 diabetes. The study lasts approximately 8 weeks and is conducted as an out-patient.

 

Actively Recruiting: Tercica’s Increlex Registry

This clinical trial enrolls participants who are receiving or who have received Increlex® (mecasermin of rDNA origin) to treat severe short stature. This study evaluates the safety and efficacy of Increlex®. This study lasts several years (as long as the participant is taking Increlex®) and is conducted in the out-patient setting, but no additional visits are required beyond routine clinical care encounters.

 

Actively Recruiting: Tolerx’s TRX4_DM_018_US_10 DEFEND-2 Trial for Type 1 Diabetes

This clinical trial is designed to evaluate the safety and potential efficacy of an infused protein therapy called otelixizumab to prevent progression of disease and to reduce the destruction of ß-cells. At enrollment, participants must have been diagnosed with type 1 diabetes within the past 90 days, be between the ages of 12 to 45 years, and weigh at least 31 kilograms (68.2 pounds). This study involves participation for approximately 2 years. Several visits are conducted in the out-patient setting, and overnight stays are not required.

 

Actively Recruiting: Pfizer’s TRN 87-052-45 KIGS Registry

This clinical trial enrolls participants who are receiving or who have received GENOTROPIN® (somatropin of rDNA origin) to treat short stature. This study evaluates the safety and efficacy of GENOTROPIN®. This study lasts several years (as long as the participant is taking GENOTROPIN®) and is conducted in the out-patient setting. No additional visits are required beyond routine clinical care encounters.

 

Actively Recruiting: TrialNET TN01 – For Relatives of Type 1 Diabetics

Preventing Type 1 diabetes is the main goal of TrialNET. We will screen family members to find their risk for type 1 diabetes. This clinical trial is open to subjects who are between the ages of 1 to 45 years old AND have a relative (parent, child, brother or sister) who has been diagnosed with Type 1 diabetes before the age of 40 years or age 1 to 20 years old AND have a relative (niece, nephew, aunt, uncle, grandparent, half-sibling or cousin) who was diagnosed with type 1 diabetes before the age of 40 years. This study requires several visits over a five (5) year period. The visits are done within a clinic or hospital setting but overnight stays are not required.

 

Active but Closed to Enrollment: MacroGenics’ Protégé Study for Type 1 Diabetes Mellitus

This clinical trial is designed to evaluate the safety and potential efficacy of an infused protein therapy called teplizumab to prevent progression of disease and to support ß-cell regeneration. At enrollment, participants must have been recently diagnosed with type 1 diabetes (within the past 90 days), be between the ages of 8 to 35 years, and weigh at least 36 kilograms (79.2 pounds). This study involves participation for approximately 2 years. Several visits are conducted in the hospital setting, but overnight stays are not required.

 

Active but Closed to Enrollment: MacroGenics’ Protégé ENCORE Study for Type 1 Diabetes Mellitus

This clinical trial is designed to evaluate the safety and potential efficacy of an infused protein therapy called teplizumab to prevent progression of disease and to support ß-cell regeneration. At enrollment, participants must have been recently diagnosed with type 1 diabetes (within the past 90 days), be between the ages of 8 to 35 years, and weigh at least 36 kilograms (79.2 pounds). This study involves participation for approximately 2 years. Several visits are conducted in the hospital setting, but overnight stays are not required.

 

Active but Closed to Enrollment: MacroGenics’ CP-MGA031-06 SUBCUE study for Type 1 Diabetes

This clinical trial is designed to evaluate the safety and potential efficacy of an infused protein therapy called teplizumab support ß-cell regeneration. At enrollment, participants must have been diagnosed with type 1 diabetes (greater than 12 weeks but less than 52 weeks), be between the ages of 18 to 35 years, and be currently receiving insulin therapy. This study involves participation for approximately 91 days. Several visits are conducted in the hospital setting, but overnight stays are not required.

 

Active but Closed to Enrollment: Diamyd’s DiaPrevent Study for Type 1 Diabetes Mellitus

This clinical trial is designed to assess the safety and potential efficacy of an injected vaccine to slow or halt disease progression. Participants will receive two subcutaneous injections in a prime-and-boost regimen over a period of 30 days for all participants, followed by 2 additional single doses over a 9-month period. At enrollment, participants must have been recently diagnosed with type 1 diabetes (within the past 90 days) and be between the ages of 10 to 21 years. Participants will be followed for a total of 30 months, with a blinded study period of 15 months and an extension study period of 15 months. The study is conducted as an out-patient.


Our close research partners offer additional details online about ongoing research and training activities. Please explore The Tennessee Clinical Trials Network, Children's Foundation Research Center of Memphis, St. Jude Children's Research Hospital and King Saud University .