Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05769127
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2023-02-22
Brief Title:
Diabetes Prevention and Education
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Baltimore Metropolitan Diabetes Regional Partnership BMDRP Diabetes Prevention Program and Diabetes Self-Management Training Outcomes
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 105 of adults report prediabetes and 337 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
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 105 of adults report prediabetes and 337 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 222 among White Non-Hispanic adults and 420 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 144 of Baltimore City adult residents and 269 of residents aged 65 and older have diabetes compared to 121 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 445 vs 238 deaths per 100000 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
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 144 of Baltimore City adult residents and 269 of residents aged 65 and older have diabetes compared to 121 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 445 vs 238 deaths per 100000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None