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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896140
• Other study ID #: 2016-07
• Status: Completed
• Start date: April 2016
• Est. completion date: September 2018

Study information

• Verified date: February 2019
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Other:
• Type 2 diabetes in WhyWAIT Program
The sum of servings per day of milk, cheese, yogurt, and other dairy foods.

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Joslin Diabetes Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1C (A1C)		24 weeks
Secondary	Change in body weight		24 weeks
Secondary	Change in low-density lipoprotein (LDL)		24 weeks
Secondary	Change in high-density lipoprotein (HDL)		24 weeks
Secondary	Change in total cholesterol		24 weeks
Secondary	Change in triglycerides		24 weeks
Secondary	Change in fasting plasma glucose		24 weeks
Secondary	Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index		24 weeks
Secondary	Height in meters		24 weeks
Secondary	Change in body fat percentage		24 weeks
Secondary	Change in fat free mass		24 weeks
Secondary	Change in total body water		24 weeks
Secondary	Change in waist circumference		24 weeks
Secondary	Change in trunk fat percentage		24 weeks
Secondary	Change in visceral fat level		24 weeks
Secondary	Change in blood pressure		24 weeks
Secondary	Change in c-reactive protein level		24 weeks