Clinical Studies

Finding the Patient's Voice: Development of Practical Approaches for Adolescent and Family Focused Diabetes Prevention Programs

The purpose of this research study is to develop a modified version of the ENCOURAGE Healthy Families to develop PowerHouse, a family-based diabetes prevention program.

Inclusion criteria:

  1. Age 7-18
  2. Overweight
  3. At least 2 of the following risk factors: a) diagnosis of prediabetes b) family history of T2D c) belong to a minority race/ethnic group d) have conditions related to insulin resistance e) had gestational diabetes or were exposed to gestational diabetes in utero
  4. Family support person willing to participate in the study- preferably a parent at risk for T2D

Powerhouse program is implemented at the Boner Fitness & Learning Center in Indianapolis.

Lifestyle-Related Health Outcomes in Prediabetes and Diabetes (DIG IT Study)

Dig It evaluates the effectiveness of modifications on diet and physical activity regarding the prevention of type 2 diabetes.

Inclusion criteria

  1. Age 10-21
  2. Tanner stage II-V
  3. Body mass index 85th percentile for age and sex

Those who are found to be eligible after screening will be randomized to the health coaching arm or one-time dietary consult arm.

Patient-Centered Decision Support to Improve Diabetes Management in Pre-Teens and Adolescents with Type 1 Diabetes

This study utilizes a human-centered design approach to develop a patient-centered diabetes computer-based decision support module within the Child Health Improvement through Computer Automation (CHICA) program. This will provide patient-centered, automated decision support to diabetes providers caring for youth (≥ 12 years of age) with T1D and prompts the provision of care according to ADA recommended standards. Upon development, the module will be tested in health clinics.

  1. A Randomized, Double-Blind Study with an Open-Label Extension Comparing the Effect of Once-Weekly Dulaglutide with Placebo in Pediatric Patients with Type 2 Diabetes Mellitus (AWARD-PEDS: Assessment of Weekly AdministRation of LY2189265 in Diabetes-PEDiatric Study) - The purpose of this study is to evaluate the use of once weekly dulaglutide (0.75 and 1.5 mg, pooled) compared with placebo in pediatric patients with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control despite diet and exercise, with or without metformin and/or basal insulin.
  2. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alogliptin Compared With Placebo in Pediatric Subjects With Type 2 Diabetes Mellitus – The purpose of this study is to evaluate the efficacy and safety of alogliptin 25 mg once daily (QD) compared to placebo, in children and adolescents 10 to 17 years, inclusive, at the time of randomization, with a confirmed diagnosis of type 2 diabetes mellitus (T2DM) and who are experiencing inadequate glycemic control.

Dr. Nabhan

Colesevelam Oral Suspension as Monotherapy or Add-On to Metformin Therapy in Pediatric Subjects with Type 2 Diabetes Mellitus

The study will evaluate how safe and tolerable Colesevelam HCl Oral Suspension is as a treatment for children with type 2 diabetes mellitus.