Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk Factors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2, Obesity

Intervention / Treatment
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* Other: Type 2 diabetes in WhyWAIT Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Subject is pregnant or lactating Subject has a heart pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 diabetes in WhyWAIT Program<br>Patients with type 2 diabetes who are participating in Joslin Diabetes Center's 12-week intensive diabetes weight management program (WhyWAIT). | Other: Type 2 diabetes in WhyWAIT Program<br>* The sum of servings per day of milk, cheese, yogurt, and other dairy foods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1C (A1C) |  | 24 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Obesity, Nutrition, Dairy