Diabetes Mellitus, Type 2, Obesity
Conditions
Keywords
Type 2 diabetes, Obesity, Nutrition, Dairy
Brief summary
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
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.
Interventions
The sum of servings per day of milk, cheese, yogurt, and other dairy foods.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Subject is participating in the Weight Achievement and Intensive Treatment (Why WAIT) program 2. Subject is male or female ages 18-75 3. Subject has type 2 diabetes for at least three months prior to screening and treated with any antihyperglycemic medication
Exclusion criteria
1. Subject is pregnant or lactating 2. Subject has a heart pacemaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hemoglobin A1C (A1C) | 24 weeks |
Secondary
| Measure | 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 |
Countries
United States
Contacts
Joslin Diabetes Center