Status:
COMPLETED
Diabetes Data-Assisted Remission Trial (DDART)
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
UnitedHealth Group
Conditions:
Type 2 Diabetes
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study team will study the efficacy of a high intensity medical weight loss intervention paired with a digital platform to create weight loss and induce remission of type 2 diabetes mellitus (T2DM)...
Detailed 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...
Eligibility Criteria
Inclusion
- Inclusion:
- Individuals with T2DM diagnosed within the past 6 years
- Body Mass Index (BMI) of 30-39.9 kg/m2.
- Participants must have an HbA1c between 6.5-11.9%.
- Participants should be able to participate in all aspects of the recommended interventions, including being able to participate in exercise, make recommended dietary changes, and engage in individual and group counseling.
- Exclusion criteria:
- Poorly controlled depression
- Recent hospitalization for psychosis or bipolar disorder
- Poorly controlled blood pressure (\>159/99)
- Prior surgical procedure for weight control or liposuction
- Unable to make changes to their diet
- Unable to exercise (walk for at least 6 minutes and perform simple strength and stretch exercise tests)
- Use of weight loss medications in previous 3 months
- Recent self-reported weight change (+/- 15lbs)
- Current use of oral corticosteroids more than 5days/month
- Cardiovascular disease event within the past 6 months
- Severe pulmonary disease requiring supplemental oxygen
- Renal failure (end stage renal disease)
- History of non-skin cancer in the past 5 years
- Major liver dysfunction within the last 2 years
- Recently quit smoking less than 6 months prior
- Inability to attend visits and adhere to study protocols
- Pregnancy or currently lactating
Exclusion
Key Trial Info
Start Date :
June 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2024
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04663061
Start Date
June 9 2021
End Date
November 14 2024
Last Update
March 3 2025
Active Locations (1)
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1
Wake Forest Univesity Health Sciences
Winston-Salem, North Carolina, United States, 27157