Ongoing Clinical Trials

Effect of Intravenous Alpha-1 Antitrypsin on Preserving Beta-cell Function in New-onset Type 1 Diabetes Mellitus (NIAID) (not yet recruiting) (PI: Lee- Subs: Soyka, Harlan)

A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Impact of Diamyd® on the Progression of Diabetes in Patients Newly Diagnosed with Type 1 Diabetes Mellitus (Diamyd Therapeutics AB) (PI: Soyka – Subs: Lee, Nwosu, Harlan)

TRX4 Therapeutic Evaluation of Different Multi-Dose Regimens in Type 1 Diabetes Mellitus (TTEDD) (Tolerx, Inc.) (PI: Mordes – Subs: Lee, Aronin, Gueseva, DeSilva, Hartigan, Ciccarelli) (closed to recruitment)

DEFEND-2: Durable-Response Therapy Evaluation for Early- or New-Onset Type 1 Diabetes (Tolerx, Inc.) (enrolling) (PI: Mordes – Subs: Lee, Guseva, Aronin, Hartigan)

TrialNet Natural History Study of the Development of Type 1 Diabetes: (NIDDK) (PI: Lee – Subs: Soyka, Nwosu, Angelescu, Hardy, Malkani, Goller)

TrialNet Oral Insulin Study for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus: (NIDDK) (PI: Lee – Subs: Hardy, Soyka, Nwosu, Angelescu)

PETS-DM Study: Teaching Parents of Newly Diagnosed Young Children with Type 1 Diabetes Management using a High Fidelity (Robotic) Patient Simulator (NINR) (PI: Sullivan-Bolyai – Sub: Lee)

Glycemic Control in Children and Adolescents with Double Diabetes: Trial of Optimized Insulin - Metformin Regimen (Novonordisk) (PI: Nwosu—sub Lee) (not yet recruiting)

Feasibility of a Lifestyle Intervention in Adolescent Girls with the Metabolic Syndrome Study (Meyers) (recruiting only controls) (PI: Soyka – Subs: Bodenlos, Huehls, Prince)

Vitamin D Study (FDSP) (PI: Nwosu)

Sibling Support of Pediatric Diabetes Self-Management: (NIDDK) (RI PI: Wendy Plante, PhD / UMass PI: Leslie Soyka, MD)

Protocol MS316: Recombinant Human Growth Hormone (rhGH) and Recombinant Human Insulin-Like Growth Factor-1 (rhIGF-1) Combination Therapy in Children with Short Stature Associated with IGF-1 Deficiency: A Three-year, Randomized, Multicenter, Open-label, Parallel-group, Active Treatment Controlled, Dose Selection Trial (Tercica, Inc.) (PI: Soyka – Sub: Nwosu)

Voiding Dysfunction in Children with Diabetes (PI: Lee)

The Role of Adipose Inflammation in the Metabolic Sequelae associated with Childhood Obesity (PI: Hardy)

The Role of Peripheral Mononuclear Cells in the Metabolic Sequelae associated with Early Obesity (PI: Hardy)

Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study (closed to recruitment) (NIH) (PI: Angelescu – Subs: Lee, Soyka, Nwosu, Hardy)