DiabetesNCT05769127
Diabetes Prevention and Education
A study testing Diabetes Prevention Program (DPP), Diabetes Self-Management Training (DSMT) in people with Diabetes and Pre Diabetes, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Diabetes, Pre Diabetes, Fatty Liver
- What is being tested?
- Diabetes Prevention Program (DPP), Diabetes Self-Management Training (DSMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2023to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Normoglycemia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Center for Diabetes and Endocrinology
Baltimore, Maryland, 21201
About this study
Official title: Baltimore Metropolitan Diabetes Regional Partnership (BMDRP) Diabetes Prevention Program and Diabetes Self-Management Training Outcomes
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.
Read the 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.
- Conditions
- Diabetes, Pre Diabetes, Fatty Liver, Body Weight Changes
- Being tested
- Diabetes Prevention Program (DPP), Diabetes Self-Management Training (DSMT)
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance, Fatty Liver, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Prevention Program (DPP), Diabetes Self-Management Training (DSMT)Other
DPP lifestyle intervention program DSMT education on diabetes and lifestyle changes
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Other: Diabetes Prevention Program (DPP), Diabetes Self-Management Training (DSMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollees into DPP and DSMT
Measure enrolled participants in DPP or DSMT programs
Measured: end of calendar year enrollment, yearly for 3 years
Change in body weight for DPP participants
Change in weight from baseline to 12 months after participating in DPP lifestyle intervention
Measured: 12 months
Secondary outcomes (3)
Change in diabetes control for DSMT participants
Change in hemoglobin A1c from baseline to 12 months after enrolling in diabetes education program
Measured: 12 months
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)
Measured: 12 months
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start26 Apr 2023
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
Why it stopped: funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KASHIF M MUNIR, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769127
- Sponsor's protocol ID
- HP-00102730
- Status last verified
- Jun 2025
- First submitted
- 22 Feb 2023
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baltimore Metropolitan Diabetes Regional Partnership (BMDRP) Diabetes Prevention Program and Diabetes Self-Management Training Outcomes
- ClinicalTrials.gov ID
- NCT05769127
- Acronym / sponsor ID
- HP-00102730
- Conditions
- Diabetes, Pre Diabetes, Fatty Liver, Body Weight Changes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Diabetes Prevention Program (DPP), Diabetes Self-Management Training (DSMT)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 |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Normoglycemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Prevention Program (DPP), Diabetes Self-Management Training (DSMT)DPP lifestyle intervention program DSMT education on diabetes and lifestyle changes | Other | Intervention |
Primary outcome
Enrollees into DPP and DSMT
Time frame: end of calendar year enrollment, yearly for 3 years
Measure enrolled participants in DPP or DSMT programs
Change in body weight for DPP participants
Time frame: 12 months
Change in weight from baseline to 12 months after participating in DPP lifestyle intervention
3 secondary outcomes
Change in diabetes control for DSMT participants
Time frame: 12 months
change in body composition in DPP participants
Time frame: 12 months
change in liver elastography in DPP participants
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Prevention Program (DPP), Diabetes Self-Management Training (DSMT) in people with Diabetes and Pre Diabetes, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollees into DPP and DSMT (time frame: end of calendar year enrollment, yearly for 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.