Diabetes Data-Assisted Remission Trial (DDART)
Type 2 Diabetes, Obesity
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes, Obesity, Weight management, Diabetes education, Diabetes remission
Eligibility Criteria
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
Sites / Locations
- Wake Forest Univesity Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
High intensity medical weight loss (HIWL)
Diabetes self-management education (DSME)
High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM)
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings. The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.