Department of Pediatrics

Pediatric Diabetes and Endocrinology Clinical Studies

Master
Content

Bone Health and Metabolism in Youth (H-45986)
Adolescents and young adults (ages 12-18 years; normal weight and overweight) with and without type 2 diabetes are needed for a research study to investigate the effect of obesity and childhood onset diabetes on bone health and risk of heart disease in youth.

Study of Setmelanotide In Patients With Specific Gene Defects In The Melanocortin-4 Receptor Pathway (H-51805) 
The aim of this study is to evaluate the proportion of obese patients with genetic defects in the melanocortin-4 receptor (MC4R) pathway who achieve a clinically meaningful reduction in body weight in response to setmelanotide versus placebo.

A Study of Setmelanotide In Patients With Specific Gene Defects In The Melanocortin-4 Receptor Pathway (H-50539)
To evaluate the proportion of obese patients with genetic defects in the melanocortin-4 receptor (MC4R) pathway who achieve a clinically meaningful reduction in body weight in response to setmelanotide after an initial response to open-label treatment.

Genetic Disorders of Obesity Program Database (H-44596)
The goal of this study is to establish a database of pediatric patients with early-onset obesity who have been phenotypically well-characterized through a variety of standardized assessments.

Oxidative Stress and Mitochondria in Pediatric Type 2 Diabetes (H-52054)
Adults with T2D have very low levels of glutathione, which puts them at risk of harm from oxidative stress. Could children with diabetes also have low glutathione levels, and is this the reason why diabetes harms children so quickly? 

Adapting and Assessing the Feasibility of a Telehealth Diabetes Prevention Program for Hispanic Adolescents (H-50331)
Adapt an evidence-based diabetes prevention program for delivery via telehealth and to test the feasibility of this study among Hispanic adolescents (12-16 years) with obesity.

RADIANT (Rare and Atypical Diabetes Network) (H-46235)
The purpose of RADIANT study is to discover and classify new and unusual forms of diabetes.

TrialNet Affiliate Site: Pathway to Prevention (H-27050)
The aim of this study is to identify individuals at risk for type 1 diabetes, seeking relatives of individuals with type 1 diabetes.

TrialNet Affiliate Site: Prevention and New Onset Trials (H-36243)
The aim of this study is to conduct clinical trials for prevention of type 1 diabetes and in patients with new-onset type 1 diabetes to preserve beta-cell function.

Type 1 Diabetes Genetic Risk Scores (GRS) in TrialNet (H-45218)
The aim of this study is to test the type 1 diabetes genetic risk scores for predication of type 1 diabetes and selection of candidates for prevention trials.

SWPDC FDA Real World Evidence Study for Type 1 Diabetes (H-46474)
The aim of this study is to develop a standalone software system and application that will provide contextual and clinically relevant data dashboards synthesized from multiple devices to enable improved patient encounters and clinical management of acute glycemic events and impact long term clinical outcomes for youth with T1D. 

Arginine Metabolism in Pediatric Type 2 Diabetes (ARMET Study) (H-51936)
This study aims to investigate arginine metabolism and the effect of arginine administration in children with type 2 diabetes compared to healthy controls. 

DISCOVER (Diabetes Study of Children of Diverse Ethnicity and Race). (H-48980)
The aim of this study is to test type 1 diabetes genetic risk scores in combination with other characteristics present at diabetes diagnosis to accurately and timely classify diabetes type in racially/ethnically diverse youth. 

Omnipod Horizon Preschool Cohort (H-48024)
This study is a single-arm, multi-center, prospective clinical study to evaluate the safety and effectiveness of the Omnipod Horizon Automated Glucose Control System in preschool children (2-5.9 years) with type 1 diabetes.

Omnipod Horizon Pivotal Study (H-46880)
This study is a single-arm, multi-center, prospective clinical study to evaluate the effectiveness of the Omnipod Horizon Automated Glucose Control System in children aged 6-13.9 years and adults aged 14-70 years.

Enhancement of Biomarkers for Type 1 Diabetes (H-41091)
The aim of this study is to utilize immunologic biomarkers, in particular a variant-specific IA-2 autoantibodies, for type 1 diabetes prediction.

Bone Health and Metabolism in Youth (H-45986)
Adolescents and young adults (ages 12-18 years; normal weight and overweight) with and without type 2 diabetes are needed for a research study to investigate the effect of obesity and childhood onset diabetes on bone health and risk of heart disease in youth.

AB Classification Study in Pediatric Diabetes (H-45745)
This is a study to test the usefulness of new classification system in pediatric diabetes using islet autoimmunity and insulin production capacity.  And to identify biomolecular differences by fasting plasma metabolomics between type 1 diabetes and type 2 diabetes compared to healthy controls. 

A Phase 3 Randomized Controlled Trial of Ladarixin in New-Onset Type 1 Diabetes (H-49339)
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladaraxin in patients with new-onset type 1 diabetes and a low residual β-cell function at baseline.

DiaBetter Together - Type 1 Diabetes (H-45360)
This randomized control trial is testing a strengths-based peer support program for young adults with type 1 diabetes who are transitioning from pediatric to adult diabetes healthcare. 

PRISM- Promoting Resilience in Stress Management Intervention (H-45623)
This randomized control trial is testing a resilience-building skills program for adolescents with T1D and elevated diabetes distress 

Addressing Social Needs and Behavioral Health Early in the Type 1 Diabetes Course to Mitigate Inequitable Health Outcomes among Socioeconomically Disadvantaged Minority Youth (H-49311)
The aim of this study is to mitigate health disparities by addressing social needs and behavioral health early in the course of type 1 diabetes.