Research/Clinical Trials

University of Iowa Children's Hospital is involved in a variety of research focusing on the prevention, intervention, and treatment of Type 1 diabetes. Research opportunities exist for children and adolescents with Type 1 diabetes as well as their family members. Below you will find a brief description of our current research projects.

DirecNet
Diabetes Research in Children Network (DirecNet) is a network of clinical centers dedicated to researching the potential use of glucose monitoring technology and its impact on the management of Type 1 diabetes in children. The primary aim of DirecNet is to determine the optimal utilization of continuous glucose monitors in the management of T1DM in children, assess the impact of continuous glucose monitoring on quality of life for the child and family, to assess possible changes in neurocognitive function and how it relates to frequency of hypoglycemia in young children with Type 1 diabetes, evaluate and develop distinct, age-appropriate treatment strategies to T1DM in children, use continuous glucose monitoring to characterize the glycemic profile of nondiabetic children, and develop statistical methods for the analysis of continuous glucose monitoring data.

Current Studies
For more information about any of these studies, please call 866-309-0837 or e-mail julie-coffey@uiowa.edu.

• Randomized Clinical Trial to Assess the Efficacy and Safety of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes in Young Children (4 to 10 Year Olds)
  Determine the efficacy, tolerability, safety, and effect on quality of life of the continuous glucose monitors in young children with Type 1 diabetes. Enrollment open.
  
• Pilot Study to Assess the Feasibility of Real-time Continuous Glucose Monitoring in the Management of Infants and Toddlers with Type 1 Diabetes
  Determine if it is possible to use continuous glucose monitors (CGM) in children with Type 1 diabetes who are less than 4 years old and how parents feel about their child’s using a CGM. Enrollment open.
• Relationship Between Loss of beta-cell Function and Loss of alpha-cell Response to Hypoglycemia Early in Type 1 Diabetes
  Determine the relationship of cells in the pancreas that produce insulin and cells that produce glucagon in children between the ages of 8 and 18 to help doctors control Type 1 diabetes better with fewer low blood sugar problems. Enrollment open.

Type 1 Diabetes TrialNet
Type 1 Diabetes TrialNet is a network of international diabetes research centers working together with sites throughout the United States, Canada, Europe, Australia and New Zealand. This network is dedicated to the study, prevention, and early treatment of Type 1 diabetes.

Current studies
For more informationabout any of these studies, call 866-309-0837 or e-mail joanne-cabbage@uiowa.edu.

• Natural History Study of the Development of Type 1 Diabetes
  Relatives of people with Type 1 diabetes have a 10 to 15 times greater risk for developing the disease than people with no family history. TrialNet is screening close blood relatives of people with Type 1 diabetes to identify those who are at increased risk for developing Type 1 diabetes. People who qualify and choose to participate in the Natural History study may also be offered an opportunity to enter diabetes prevention study in the future. Enrollment open
  
• Nutrition Intervention to Prevent (NIP) Type 1 Diabetes Pilot Trial
  University of Iowa Children's Hospital is one of nine medical centers in the United States conducting a pilot study to determine if an omega-3 fatty acid naturally found in some foods can prevent Type 1 diabetes in babies who may be at risk of developing the disease. Enrollment closed.
• Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
  Assess whether oral insulin administration will delay or prevent the onset of T1DM to subjects age 3 to 45 years of age who are at risk for the disease.

Macrogenics: The Protege Study

• Phase 2/3, Randomized, Double Blind, Multicenter, Multinational, 4 Arm, Controlled, Dose Ranging Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non Binding, Anti CD3 Monoclonal Antibody, in Children and Adults with Recent Onset Type 1 Diabetes Mellitus
  Subjects between the ages of 8 and 18 years of age who weigh at least 79 pounds are invited to participate in aresearch study testing an investigational medicine called teplizumab to evaluate its safety and see if it helps people newly diagnosed with Type 1 diabetes with the hope it will protect the remaining beta cells in the pancreas before they lose their ability to produce insulin. If templizumab is successful, a person may need less insulin and their blood glucose may be easier to control. For more information, call 866-309-0837 or e-mail julie-coffey@uiowa.edu. Enrollment open.

Type 1 Diabetes Genetics Consortium
The Type 1 Diabetes Genetics Consortium is a collaborative effort to develop resources for the purpose of identifying genes that increase (or decrease) an individual's risk for type 1 diabetes. The scientific objectives are to ascertain, study and establish a renewable source of DNA to create a database for the scientific community with clinical, genetic, and medical history information that would facilitate the search for Type 1 diabetes susceptibility genes, to provide a centralized DNA repository to allow targeted studies of genetic structure and function for Type 1 diabetes, and to evaluate opportunities to extend the results of research to develop methods of risk prediction, prevention and therapy in the area of Type 1 diabetes.

Enrollment is open to families who self identify as Mexican-American or African-American and have one child with Type 1 diabetes. In these families we would like the participation of both parents and the child with diabetes. For more information, please call 866-309-0837 or e-mail joanne-cabbage@uiowa.edu.

ENDOCRINOLOGY CLINICAL TRIALS

Our endocrine clinical trials are primarily industry-sponsored, multi-center studies that focus on an endocrine medication. Typical areas of interest include safety and efficacy of a medication, new indications for treatment, dosing regimens, and medication delivery devices. Trial subjects are recruited from our existing clinical population.

Our open clinical trials are as follows:

The effect of growth hormone treatment on children with classical or nonclassical growth hormone deficiency: National Cooperative Growth Study.

A four-year, open-label, multi-center randomized two-arm study of Genotropin™ in idiopathic short stature patients: Comparing an individualized, target-driven treatment regimen to standard dosing of Genotropin™.

GeNeSIS: The genetics and neuroendocrinology of short stature international study.

KIGS: Pfizer international growth study.

An open-label, non-comparative trial to evaluate the safety, efficacy and pharmacokinetics of Faslodex™ in girls with progressive precocious puberty associated with McCune-Albright Syndrome.

BASIC DIABETES RESEARCH

The laboratory of Andrew Norris, MD, PhD, is committed to the discovery of early molecular events that contribute to the pathophysiology and complications of diabetes. His laboratory has several active projects towards this end. (1) Characterization of the activity of muscle PPAR-gamma as a transcriptional switch to prevent the pre-diabetic state. (2) Studying of interventions to prevent the metabolic consequences of developmental exposure to excess glucose, fat, or insulin. (3) Use of bioinformatics to help discover novel master regulators of metabolic dysfunction and its rescue.