- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04663061
Diabetes Data-Assisted Remission Trial (DDART)
Data-Assisted Approach for High Intensity Medical Weight Loss for Diabetes Remission
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chelsea Newman, MPH
- Phone Number: 336-713-1411
- Email: cmnewman@wakehealth.edu
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest Univesity Health Sciences
-
Contact:
- Chelsea Newman, MPH
- Phone Number: 336-713-1411
- Email: cmnewman@wakehealth.edu
-
Principal Investigator:
- Jamy Ard, MD
-
Sub-Investigator:
- Joseph Aloi, MD
-
Sub-Investigator:
- Haiying Chen, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High intensity medical weight loss (HIWL)
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.
|
Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Active Comparator: Diabetes self-management education (DSME)
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 will receive standard of care diabetes education
|
Experimental: High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM)
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.
|
Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Participants will use CGM devices to track blood glucose levels in near real time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Weight
Time Frame: baseline through 12 months
|
Change in weight from baseline
|
baseline through 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hemoglobin A1c
Time Frame: baseline through 12 months
|
Change in hemoglobin A1c
|
baseline through 12 months
|
Number of Subjects in Diabetes Remission
Time Frame: 12 months
|
Achieving A1c <6.5% and no anti-diabetes medications
|
12 months
|
Continuous Glucose Monitoring (CGM) Time in Range
Time Frame: baseline through 12 months
|
Collected by FreeStyle Libre.
Average time spent at an average glucose of 100 mg/dL or lower.
|
baseline through 12 months
|
CGM Time in Range--Post-meal Glucose
Time Frame: baseline through 12 months
|
Collected by FreeStyle Libre.
Average time spent at a post-meal glucose level of 110 mg/dL or lower.
|
baseline through 12 months
|
CGM Time in Range--Fasting Glucose
Time Frame: baseline through 12 months
|
Collected by FreeStyle Libre.
Average time spent in normal fasting glucose between 72-85 mg/dL.
|
baseline through 12 months
|
CGM Episodes of Hypoglycemia
Time Frame: baseline through 12 months
|
Collected by FreeStyle Libre.
Number of episodes.
|
baseline through 12 months
|
CGM Glucose Variability
Time Frame: baseline through 12 months
|
Collected by FreeStyle Libre.
Coefficient of variance
|
baseline through 12 months
|
CGM Average Glucose
Time Frame: baseline through 12 months
|
Collected by FreeStyle Libre.
|
baseline through 12 months
|
Automated Self-Administered 24-hour (ASA24) Total Daily Energy Intake
Time Frame: baseline, 3 months, 6 months, and 12 months
|
kilocalories averaged across 3 days
|
baseline, 3 months, 6 months, and 12 months
|
ASA24 Macronutrient Composition of Diet
Time Frame: baseline, 3 months, 6 months, and 12 months
|
%Carbohydrate/Fat/Protein; averaged across 3 days
|
baseline, 3 months, 6 months, and 12 months
|
ASA24 Number of Eating Episodes Per Day
Time Frame: baseline, 3 months, 6 months, and 12 months
|
averaged across 3 days
|
baseline, 3 months, 6 months, and 12 months
|
ASA24 Healthy Eating Index (HEI)-2015 score
Time Frame: baseline, 3 months, 6 months, and 12 months
|
A validated summary measure of dietary quality, rated on a 100-point scale with a higher score denoting better diet quality
|
baseline, 3 months, 6 months, and 12 months
|
Daily Step Counts
Time Frame: baseline, 3 months, 6 months, and 12 months
|
Collected by pedometer over 7 days during each period.
At the end of the 7th day, participants will record the final step count, and return the pedometer to the study team via a pre-stamped mail envelope.
|
baseline, 3 months, 6 months, and 12 months
|
International Physical Activity Questionnaire (IPAC) short form: moderate-vigorous physical activity minutes
Time Frame: baseline, 3 months, 6 months, and 12 months
|
A validated self-report measure of daily physical activity levels.
Responses are given as minutes per day over the last week of moderate and vigorous physical activity.
Outcome is average total minutes/week.
|
baseline, 3 months, 6 months, and 12 months
|
International Physical Activity Questionnaire (IPAC) short form: walking minutes
Time Frame: baseline, 3 months, 6 months, and 12 months
|
A validated self-report measure of daily physical activity levels.
Responses are given as minutes per day over the last week of walking for exercise.
Outcome is average total minutes/week.
|
baseline, 3 months, 6 months, and 12 months
|
International Physical Activity Questionnaire (IPAC) short form: sitting time
Time Frame: baseline, 3 months, 6 months, and 12 months
|
A validated self-report measure of daily physical activity levels.
Responses are given as minutes per day over the last week of sitting time.
Outcome is average total minutes/week.
|
baseline, 3 months, 6 months, and 12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jamy Ard, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00067950
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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