ORLANDO (EGMN) –A community-based lifestyle intervention program significantly reduced body weight and waist circumference and lowered fasting blood glucose levels at one year compared with usual care in a study of 301 adults with prediabetes.
Results of the Healthy Living Partnerships to Prevent Diabetes (HELP PD) study were presentedJune 29th at the annual meeting of the American Diabetes Association by Dr. David C. Goff, chair of the department of epidemiology and prevention at Wake Forest University. The intervention was modeled after the landmark Diabetes Prevention Program study DPP), in which individuals at high risk for type 2 diabetes who received individual lifestyle counseling had a 58% reduction in the development of diabetes over a 3-year period (N Engl J Med 2002;346:393-403). Both studies were funded by the National Institute of Diabetes, Digestive and Kidney Diseases.
“In the seven years since publication of the DPP, there has been great interest in developing and testing ways to translate those behavioral weight loss approaches to community settings in ways that can reach the large population of people with pre-diabetes,” Dr. Goff said during a press briefing held at the American Diabetes Association meeting.
In HELP PD, the DPP intervention was modified to a group-based counseling session with about 10-14 people per group. In another difference, specially trained lay community health workers who had brought their diabetes under control delivered the intervention, which included encouragement to change eating behaviors and to exercise for up to 180 minutes per week, with an emphasis on walking.
In the intervention group, sessions were held weekly for the first 6 months and monthly for the next 18 months. The usual care group received two individual sessions with a registered dietician during the first 3 months of the study and a monthly newsletter throughout the 2 years. Telephone calls were also included.
The subject population was about 40% male, about 75% Caucasian, and slightly less than a 25% African-American. They had a mean age of 58 years, a mean body weight of 94 kg, the mean BMI was 33 kg/m2 , and mean fasting blood glucose was 105 mg/dL.
Subjects in the intervention group lost an average of 7 kg in the first intervention year, compared with a loss of 1.5 kg in the usual care group. Waist circumference was reduced by 5.9 cm in the intervention group, compared with less than 1 cm with usual care.
The primary endpoint, fasting glucose, dropped by 4.2 mg/dL in the first year, compared with 0.3mg/dL in the usual care group. All of these comparisons are highly statistically significant. Fasting insulin levels also declined, Dr. Goff said.
Neither overall nor serious adverse events differed between the two groups. Although the sample size wasn’t large enough to assess the development of diabetes with statistical significance, there have been fewer cases among the intervention group participants, consistent with the 4 mg/dL reduction in fasting glucose. Monitoring for diabetes will be continued into a second year along with the other parameters, he said.
There are currently approximately 3,000 diabetes education programs around the country that are recognized by the ADA. In order for this intervention to take place, staff would need to be trained to administer it and policies would need to change to allow reimbursement for treatment of pre-diabetes, Dr. Goff noted.
Dr. Goff stated that he has received funding for diabetes-related research from Merck and has served on a safety monitoring board for Takeda.
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奥兰多(EGMN)——一项入选301例糖尿病前期成人患者的研究显示，与常规护理相比，实施基于社区的生活方式干预计划1年后，患者的体重、腰围和空腹血糖降低显著。
6月29日，Wake Forest大学流行病学与预防系主任David C. Goff博士在美国糖尿病学会(ADA)年会上对这项名为“构建健康生活伙伴关系，预防糖尿病”(HELP PD )研究的结果进行了报告。该研究的干预措施参照糖尿病预防计划(DPP)这项里程碑式研究。在后者中，2型糖尿病高危患者在接受个体化生活方式咨询指导3年后，发生糖尿病的风险降低了58%(N Engl J Med 2002;346:393-403)。这两项研究均由美国国立糖尿病、消化及肾疾病研究所资助。
Goff博士在这项ADA会议的新闻发布会上说：“在DPP研究发表后的这7年内，研究者对开发和检验合适的行为减肥方法并将其应用于社区环境中的广泛糖尿病前期患者产生了浓厚兴趣。”
在HELP PD研究中，研究者将DPP研究中的干预方法改进为基于小组的咨询指导会议(10~14人/组)。HELP PD研究与DPP研究的另一个区别还在于，由自身糖尿病已得到控制且经过专门培训的非专业社区卫生工作者来实施干预，包括鼓励改变饮食行为和鼓励每周进行180 min的着重于步行的运动。
干预组：在研究首6个月内，每周举行1次会议，此后18个月，每个月举行1次。常规护理组：在研究首3个月内，由注册营养师举行2次会议，并在两年研究时间内，每个月向组员发1份快讯资料。此外，还进行电话联系。
40%的受试者为男性，75%为白种人，25%为非洲裔美国人。受试者的平均年龄为58岁，平均体重为94 kg，平均BMI为33 kg/m2，平均空腹血糖为105 mg/dl。
干预第1年，干预组和常规护理组体重分别平均降低了7 kg和1.5 kg。干预组腰围缩小5.9 cm，而常规护理组腰围缩小不足1 cm。
Goff 博士表示，第1年时，主要终点空腹血糖在干预组中的降幅为 4.2 mg/dl，在常规护理组中为 0.3 mg/dl。所有上述这些差异均具有显著统计学意义。空腹胰岛素水平也出现降低。
总体不良事件和严重不良事件的组间差异均不显著。 尽管样本量不足以评价糖尿病发生率的组间差异是否具有统计学意义，但干预组发生糖尿病的病例数量较少，这与该组空腹血糖降低4 mg/dl的结果一致。他表示，将在第2年继续对糖尿病和其他指标进行监测。
目前，美国国内获ADA认可的糖尿病教育计划约为3,000项。Goff博士指出，为了实施这类干预，需要培训工作人员掌握实施的方法，并需修改政策，以允许报销糖尿病前期治疗费用。
Goff博士声明其从默沙东公司获得糖尿病相关研究资助，并且是武田公司安全监测委员会的成员。
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