Diabetes Data-Assisted Remission Trial (DDART)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obesity
- Type 2 Diabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized controlled trialMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This project will determine if a data-assisted, high intensity medical weight loss intervention (HIWL) will lead to significant weight loss and diabetes remission in individuals with a Body Mass Index (BMI) 30-39.9 kg/m2 with T2DM of less than 6 years as compared to a diabetes self-management educat...
This project will determine if a data-assisted, high intensity medical weight loss intervention (HIWL) will lead to significant weight loss and diabetes remission in individuals with a Body Mass Index (BMI) 30-39.9 kg/m2 with T2DM of less than 6 years as compared to a diabetes self-management education intervention (DSME). Complete diabetes remission is considered to be achieved when the patient is not taking any anti-diabetes medication for at least 12 months, and the Glycated Hemoglobin (HbA1c) is < 5.7%. Partial remission is achieved when the patient is not taking any anti-diabetes medication and has an HbA1c of 5.7-6.4% for at least 12 months. Using a randomized controlled study design, the study team will randomly assign 30 participants to HIWL or DSME. Participants assigned to HIWL will receive a high intensity behavioral weight loss intervention delivered using a digital patient engagement platform. Participants will be prescribed a low calorie dietary plan and a recommended physical activity program designed to produce 15-20% weight loss over 12 months. Those assigned to DSME will participate in a comprehensive diabetes education program designed to provide education and skills for optimal diabetes management plus lifestyle modification counseling to produce 5% weight loss over the same timeframe. The primary outcome of weight loss will be assessed at 12 months.
Tracking Information
- NCT #
- NCT04663061
- Collaborators
- UnitedHealth Group
- Investigators
- Principal Investigator: Jamy Ard, MD Wake Forest University Health Sciences