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临床试验/NCT05769127
NCT05769127撤回不适用

Baltimore Metropolitan Diabetes Regional Partnership (BMDRP) Diabetes Prevention Program and Diabetes Self-Management Training Outcomes

University of Maryland, Baltimore1 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2023年4月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
20,000
试验地点
1
主要终点
Change in body weight for DPP participants

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •- Normoglycemia

研究组 & 干预措施

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

干预措施: Diabetes Prevention Program (DPP), Diabetes Self-Management Training (DSMT) (Other)

结局指标

主要结局

Change in body weight for DPP participants

时间窗: 12 months

Change in weight from baseline to 12 months after participating in DPP lifestyle intervention

Enrollees into DPP and DSMT

时间窗: end of calendar year enrollment, yearly for 3 years

Measure enrolled participants in DPP or DSMT programs

次要结局

  • change in liver elastography in DPP participants(12 months)
  • Change in diabetes control for DSMT participants(12 months)
  • change in body composition in DPP participants(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

KASHIF M MUNIR

Professor of Medicine

University of Maryland, Baltimore

研究点 (1)

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