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临床试验/NCT02896140
NCT02896140已完成不适用

The Effect of Dairy Product Consumption on Glycemic Control, Body Weight and Cardiovascular Risk Factors in Patients Enrolled in the Joslin Weight Achievement and Intensive Treatment (Why WAIT) Program: A Prospective Cohort Study

Joslin Diabetes Center1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Change in Hemoglobin A1C (A1C)

研究概览

简要总结

The aim of this study is to determine the relationship between the percentage of calories from dairy intake and long-term glycemic control and weight maintenance in patients with type 2 diabetes who participate in an intensive lifestyle intervention program.

The investigators hypothesize that overweight and obese patients with type 2 diabetes who consume higher percentage of calories from dairy products during intensive lifestyle intervention programs have better glycemic control and maintenance of weight loss as compared to those who consume lower percentage of calories from dairy products.

详细描述

This is a prospective, observational clinical study where the daily intake of dairy products will be recorded and analyzed in 50 overweight/obese subjects with type 2 diabetes enrolled in the Weight Achievement and Intensive Treatment (Why WAIT) program. The Weight Achievement and Intensive Treatment (Why WAIT) program is a 12-week multidisciplinary program developed by Joslin Diabetes Center for intensive diabetes weight management in clinical practice. It includes the following components that are provided in a group setting: (1) intensive medical treatment provided by an endocrinologist and a registered nurse; (2) a structured dietary plan provided by a registered dietitian; (3) an individualized exercise training program provided by an exercise physiologist; (4) cognitive behavioral modification provided by a behavioral therapist.

Participants will be enrolled in this study for a period of 24 weeks. They will attend the Weight Achievement and Intensive Treatment (Why WAIT) program during the first 12 weeks of the study and will be followed for another 12 weeks after the program (the maintenance phase). During the intervention phase, participants will receive group education on a weekly basis for 12 consecutive weeks. During maintenance phase, participants will receive a monthly, 15 minute long, follow up phone call from the study dietitian.

Participants will be instructed to complete a 3-day food log before each visit. They will also be asked to record their dairy intake on a daily basis in a dedicated log book. These logs will be collected and analyzed by the study dietitian. Dairy consumption will be calculated as the sum of servings per day of milk, cheese, yogurt, and other dairy foods.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Subject is participating in the Weight Achievement and Intensive Treatment (Why WAIT) program
  • •Subject is male or female ages 18-75
  • •Subject has type 2 diabetes for at least three months prior to screening and treated with any antihyperglycemic medication

排除标准

  • •Subject is pregnant or lactating
  • •Subject has a heart pacemaker

研究组 & 干预措施

Type 2 diabetes in WhyWAIT Program

Patients with type 2 diabetes who are participating in Joslin Diabetes Center's 12-week intensive diabetes weight management program (WhyWAIT).

干预措施: Type 2 diabetes in WhyWAIT Program (Other)

结局指标

主要结局

Change in Hemoglobin A1C (A1C)

时间窗: 24 weeks

次要结局

  • Change in triglycerides(24 weeks)
  • Change in waist circumference(24 weeks)
  • Height in meters(24 weeks)
  • Change in fat free mass(24 weeks)
  • Change in total body water(24 weeks)
  • Change in c-reactive protein level(24 weeks)
  • Change in total cholesterol(24 weeks)
  • Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index(24 weeks)
  • Change in low-density lipoprotein (LDL)(24 weeks)
  • Change in fasting plasma glucose(24 weeks)
  • Change in trunk fat percentage(24 weeks)
  • Change in visceral fat level(24 weeks)
  • Change in blood pressure(24 weeks)
  • Change in body weight(24 weeks)
  • Change in high-density lipoprotein (HDL)(24 weeks)
  • Change in body fat percentage(24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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