Detecting and Managing Metabolic Syndrome and Pre-Diabetes in General Medicine Clinic (Feasibility)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Patients adopt healthy lifestyle behaviors leading to significant weight loss, thus reducing their risk of diabetes and heart disease
研究概览
简要总结
An educational intervention in the General Medicine Clinic aimed at both primary care providers (PCPs) and their patients with metabolic syndrome/pre-diabetes (MetSyn/PDM). Improving PCPs ability to detect and manage MetSyn/PDM, as measured by the increased incorporation of MetSyn/PDM into PCPs care plan, and increasing patients' awareness of healthy lifestyle behaviors results in positive patient health behaviors and outcomes.
详细描述
The highest diabetes prevalence in the US is among African Americans (13.3%), American Indians (12.8%), and Mexican Americans (9.5%) with 8.7% of European Americans diagnosed with diabetes. In addition, certain minorities also have much higher rates of diabetes-related complications and death, in some instances by as much as 50% more than the general population, highlighting that the greatest need for preventive measures are amongst ethnic minorities.
The efficacy of lifestyle intervention in reducing the incidence of type 2 diabetes has been established by the Diabetes Prevention Program and other studies. The Cook County Bureau of Health Services, a publicly-funded healthcare system serving a primarily low-income, uninsured, ethnically diverse population in Chicago, IL, currently treats an estimated 40,000 patients annually for type 2 diabetes and estimates that another 85,000 to 100,000 patients are at risk for developing diabetes.
Our primary objective was to test the feasibility of integrating less intensive lifestyle intervention therapy into patient visits with their primary care provider to improve weight loss and decrease the intensity of metabolic syndrome and pre-diabetes risk factors. The site of the study is the General Medicine Clinic, a busy primary care outpatient site treating approximately 12,000 patients/year and 200 patients/day, staffed primarily by medical residents supervised by attending physicians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has metabolic syndrome as defined by three or more of the five risk factors:
- •elevated blood pressure (BP) above 130 mm Hg systolic and/or 85 mm Hg diastolic or drug therapy for elevated blood pressure
- •elevated waist circumference (WC)above 35" (female) or above 40" (male)
- •reduced high-density lipoprotein (HDL) of below 40 mg/dl (male) or below 50 mg/dl (female) or drug therapy for reduced HDL
- •elevated triglycerides (TG) of 150 mg/dl or above or drug therapy for elevated TG
- •elevated fasting blood glucose (FBG) of 100 mg/dl and above and below 126 mg/dl)or pre-diabetes as defined as elevated FBG.
- •Has a primary care provider in the General Medicine Clinic (GMC).
排除标准
- •Has been diagnosed with any of the following:
- •known CAD (MI, CABG, PTCA)
- •congestive Heart Failure NYHA Class III or IV
- •Life expectancy less than 2 years
- •Non-English speaking patient
- •Patient whose physician is a PGY-3 resident, graduating before projected completion of the study
研究组 & 干预措施
Provider/Patient Intervention Arm
Lifestyle modification education and counseling for intervention patients. Diagnosis and treatment education and feedback on performance for providers of intervention patients.
干预措施: Lifestyle intervention and provider feedback (Behavioral)
Provider/Patient Control Arm
Pts will be informed that they have MetSyn and asked to speak with their PCP with any questions.
结局指标
主要结局
Patients adopt healthy lifestyle behaviors leading to significant weight loss, thus reducing their risk of diabetes and heart disease
时间窗: 1.5 years
Weight loss from baseline
Providers improve their ability to diagnose and treat metabolic syndrome/pre-diabetes.
时间窗: 1.5 years
Providers chart MetSyn in Problem List
次要结局
- Improve patient understanding of the metabolic syndrome/pre-diabetes risk parameters and the impact of healthy lifestyle changes on reducing their risk of developing heart disease and diabetes.(1.5 years)
- Create a model multidisciplinary team (physician, nurse, dietitian, health educator) to conduct group visits, lifestyle intervention education and follow-up of patients with metabolic syndrome/pre-diabetes.(1.5 years)
- Involve nursing staff in waist circumference measurement along with vital signs.(1.5 years)
- Develop a system-wide database of patients with metabolic syndrome/pre-diabetes to target for preventive care.(1.5 years)
- Establish physician discussions and documentations encouraging lifestyle changes such as weight loss, healthy dietary changes and exercise.(1.5 years)
- Assess changes in insulin resistance using the HOMA-IR index and in vascular inflammation status using C-Reactive protein in the intervention and control groups.(1.5 years)
研究者
Leon Fogelfeld MD
Chair, Division of Endocrinology
Cook County Health