Diabetes Data-Assisted Remission Trial (DDART)

Obesity Clinical Trial

Official title:

Data-Assisted Approach for High Intensity Medical Weight Loss for Diabetes Remission

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04663061
• Other study ID #: IRB00067950
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 9, 2021
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) compared to a diabetes self-management education intervention. The digital platform provides the capability to tailor the treatment plan, provide automated support, and alert providers when a participant may need more support from the clinical team. If shown to be efficacious, this research could be highly impactful, causing us to rethink our approach to care for those with T2DM and shift the paradigm for millions of individuals in the United States. Furthermore, this approach will demonstrate the feasibility of helping people engage in metabolic treatment strategies in a way that is scalable leveraging digital and mobile solutions that extend the patient-provider relationship, shift care from episodic approaches to more of an on-going model that extends into the life of the patient, while also integrated within the healthcare system workflows.

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 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, we will randomly assign 90 participants to HIWL, HIWL + continuous glucose monitoring (CGM), 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 HIWL + CGM will receive the same intervention as HIWL; in addition we will provide them with CGM to use as part of their remote monitoring on a daily basis. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: January 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity
• Type 2 Diabetes

Intervention

Behavioral:
• Medical weight loss
Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
• Diabetes education
Participants will receive standard of care diabetes education
• Continuous glucose monitoring
Participants will use CGM devices to track blood glucose levels in near real time

Locations

Country	Name	City	State
United States	Wake Forest Univesity Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	UnitedHealth Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight	Change in weight from baseline	baseline through 12 months
Secondary	Change in Hemoglobin A1c	Change in hemoglobin A1c	baseline through 12 months
Secondary	Number of Subjects in Diabetes Remission	Achieving A1c <6.5% and no anti-diabetes medications	12 months
Secondary	Continuous Glucose Monitoring (CGM) Time in Range	Collected by FreeStyle Libre. Average time spent at an average glucose of 100 mg/dL or lower.	baseline through 12 months
Secondary	CGM Time in Range--Post-meal Glucose	Collected by FreeStyle Libre. Average time spent at a post-meal glucose level of 110 mg/dL or lower.	baseline through 12 months
Secondary	CGM Time in Range--Fasting Glucose	Collected by FreeStyle Libre. Average time spent in normal fasting glucose between 72-85 mg/dL.	baseline through 12 months
Secondary	CGM Episodes of Hypoglycemia	Collected by FreeStyle Libre. Number of episodes.	baseline through 12 months
Secondary	CGM Glucose Variability	Collected by FreeStyle Libre. Coefficient of variance	baseline through 12 months
Secondary	CGM Average Glucose	Collected by FreeStyle Libre.	baseline through 12 months
Secondary	Automated Self-Administered 24-hour (ASA24) Total Daily Energy Intake	kilocalories averaged across 3 days	baseline, 3 months, 6 months, and 12 months
Secondary	ASA24 Macronutrient Composition of Diet	%Carbohydrate/Fat/Protein; averaged across 3 days	baseline, 3 months, 6 months, and 12 months
Secondary	ASA24 Number of Eating Episodes Per Day	averaged across 3 days	baseline, 3 months, 6 months, and 12 months
Secondary	ASA24 Healthy Eating Index (HEI)-2015 score	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
Secondary	Daily Step Counts	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
Secondary	International Physical Activity Questionnaire (IPAC) short form: moderate-vigorous physical activity minutes	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
Secondary	International Physical Activity Questionnaire (IPAC) short form: walking minutes	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
Secondary	International Physical Activity Questionnaire (IPAC) short form: sitting time	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