Diabetes Prevention and Education
Primary Purpose
Diabetes, Pre Diabetes, Fatty Liver
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes Prevention Program (DPP), Diabetes Self-Management Training (DSMT)
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes
Eligibility Criteria
Inclusion Criteria: Qualify for DPP with a diagnosis of pre-diabetes and elevated BMI (≥25 kg/m2 , ≥23kg/m2 if Asian) For DSMT, individuals with type 2 diabetes Exclusion Criteria: - Normoglycemia
Sites / Locations
- University of Maryland Center for Diabetes and EndocrinologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
All subjects participating in the diabetes prevention program will be offered body composition analysis and liver fat analysis, before, during, and after the lifestyle intervention
Outcomes
Primary Outcome Measures
Enrollees into DPP and DSMT
Measure enrolled participants in DPP or DSMT programs
Change in body weight for DPP participants
Change in weight from baseline to 12 months after participating in DPP lifestyle intervention
Secondary Outcome Measures
Change in diabetes control for DSMT participants
Change in hemoglobin A1c from baseline to 12 months after enrolling in diabetes education program
change in body composition in DPP participants
change in body fat and lean body mass from baseline to 12 months after completing DPP lifestyle intervention (body fat in %, with lower body fat % better outcome)
change in liver elastography in DPP participants
change in liver fat and stiffness assessed by Fibroscan at baseline and 12 months after DPP lifestyle intervention (lower liver fat and stiffness better outcomes)
Full Information
NCT ID
NCT05769127
First Posted
February 22, 2023
Last Updated
April 26, 2023
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT05769127
Brief Title
Diabetes Prevention and Education
Official Title
Baltimore Metropolitan Diabetes Regional Partnership (BMDRP) Diabetes Prevention Program and Diabetes Self-Management Training Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Type 2 diabetes mellitus is one of the fastest growing public health problems in developed and developing countries and imposes a large financial burden on health-care systems. Preventing, delaying, and managing diabetes should be a priority for health-care systems. Nationally, 38% of adults have prediabetes, with more than 80% of people with prediabetes being unaware of their condition. In Maryland, an estimated 10.5% of adults report prediabetes, and 33.7% of Baltimore City residents have obesity, an important risk factor for prediabetes.
The BMDRP aims to increase the capacity of BMDRP hospitals and community partners to offer DPP and DSMT directly in communities and will also increase the number of referrals into these programs.
Successful enrollment and completion of DPP has demonstrated reduced risk of developing type 2 diabetes for individuals with pre-diabetes. However, limited data exist on changes in body composition and liver fat in individuals completing DPP. Individuals with pre-diabetes often have obesity and non-alcoholic fatty liver disease. We will evaluate for changes in body fat and liver fat in individuals completing the DPP program.
Detailed Description
Type 2 diabetes mellitus is one of the fastest growing public health problems in developed and developing countries and imposes a large financial burden on health-care systems. Preventing, delaying, and managing diabetes should be a priority for health-care systems. Nationally, 38% of adults have prediabetes, with more than 80% of people with prediabetes being unaware of their condition. In Maryland, an estimated 10.5% of adults report prediabetes, and 33.7% of Baltimore City residents have obesity, an important risk factor for prediabetes. There is racial disparity in obesity prevalence in the City, with obesity prevalence at 22.2% among White, Non-Hispanic adults and 42.0% among Black, Non-Hispanic adults. Several randomized controlled trials have successfully proven that an intensive lifestyle intervention, like the one studied in the Diabetes Prevention Program, can delay the onset of the progression from prediabetes to type 2 diabetes. These studies have shown a decrease in relative risk of type 2 diabetes up to 60% by intensive lifestyle interventions. The National Diabetes Prevention Program is a CDC-recognized yearlong lifestyle change program that is based on these successful trials.
Type 2 diabetes is the leading cause of blindness, lower extremity amputations, and kidney disease requiring dialysis. Diabetes and its complications are primary or secondary factors in an estimated 9 percent of hospitalizations. According to the data from Maryland Behavioral Risk Factor Surveillance System (BRFSS), 14.4% of Baltimore City adult residents and 26.9% of residents aged 65 and older have diabetes, compared to 12.1% of adults statewide. The goals of Diabetes Self-Management Training (DSMT) are to improve glycemic control and reduce the risk of micro and macro-vascular complications as supported by numerous epidemiologic and interventional studies.
Health inequities are present across the Baltimore Metropolitan region. In Baltimore City, mortality rates from diabetes are almost twice as high for Black residents than for White residents (44.5 vs 23.8 deaths per 100,000 population). The BMDRP aims to increase the capacity of BMDRP hospitals and community partners to offer DPP and DSMT directly in communities and will also increase the number of referrals into these programs. Wrap-around services are critical elements of the BMDRP to mitigate the effects of poverty, food insecurity, and transportation barriers. These services will support the success of individuals in the target population and their ability to achieve diabetes prevention and management goals which will support improved health outcomes.
Successful enrollment and completion of DPP has demonstrated reduced risk of developing type 2 diabetes for individuals with pre-diabetes. However, limited data exist on changes in body composition and liver fat in individuals completing DPP. Individuals with pre-diabetes often have obesity and non-alcoholic fatty liver disease. We will evaluate for changes in body fat and liver fat in individuals completing the DPP program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Pre Diabetes, Fatty Liver, Body Weight Changes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
All subjects participating in the diabetes prevention program will be offered body composition analysis and liver fat analysis, before, during, and after the lifestyle intervention
Intervention Type
Other
Intervention Name(s)
Diabetes Prevention Program (DPP), Diabetes Self-Management Training (DSMT)
Intervention Description
DPP lifestyle intervention program DSMT education on diabetes and lifestyle changes
Primary Outcome Measure Information:
Title
Enrollees into DPP and DSMT
Description
Measure enrolled participants in DPP or DSMT programs
Time Frame
end of calendar year enrollment, yearly for 3 years
Title
Change in body weight for DPP participants
Description
Change in weight from baseline to 12 months after participating in DPP lifestyle intervention
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in diabetes control for DSMT participants
Description
Change in hemoglobin A1c from baseline to 12 months after enrolling in diabetes education program
Time Frame
12 months
Title
change in body composition in DPP participants
Description
change in body fat and lean body mass from baseline to 12 months after completing DPP lifestyle intervention (body fat in %, with lower body fat % better outcome)
Time Frame
12 months
Title
change in liver elastography in DPP participants
Description
change in liver fat and stiffness assessed by Fibroscan at baseline and 12 months after DPP lifestyle intervention (lower liver fat and stiffness better outcomes)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Qualify for DPP with a diagnosis of pre-diabetes and elevated BMI (≥25 kg/m2 , ≥23kg/m2 if Asian)
For DSMT, individuals with type 2 diabetes
Exclusion Criteria:
- Normoglycemia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aidan Ottoni-Wilhem
Phone
667-233-5900
Email
Aidan.OttoniWilhelm@umm.edu
Facility Information:
Facility Name
University of Maryland Center for Diabetes and Endocrinology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kashif Munir, M.D.
Phone
443-682-6800
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diabetes Prevention and Education
We'll reach out to this number within 24 hrs