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

Completed

• Conditions: Diabetes Mellitus, Type 2; Obesity
• Interventions: Other: Type 2 diabetes in WhyWAIT Program

• Registration Number: NCT02896140
• Lead Sponsor: Joslin Diabetes Center

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-26
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Primary Completion: 2018-07
• Study Completion: 2018-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-28
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

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Exclusion Criteria

1. Subject is pregnant or lactating
2. Subject has a heart pacemaker

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 2 diabetes in WhyWAIT Program	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).

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1C (A1C)	24 weeks

Secondary Outcome Measures

Name	Time	Method
Change in triglycerides	24 weeks
Change in waist circumference	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
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 body weight	24 weeks
Change in high-density lipoprotein (HDL)	24 weeks
Change in body fat percentage	24 weeks

Trial Locations

Locations (1)

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States