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

February 28, 2019 updated by: Joslin Diabetes Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants in Joslin Diabetes Center's Weight Achievement and Intensive Treatment (Why WAIT) program

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Other: Type 2 diabetes in WhyWAIT Program
The sum of servings per day of milk, cheese, yogurt, and other dairy foods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Hemoglobin A1C (A1C)
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joslin Diabetes Center

Investigators

  • Principal Investigator: Osama Hamdy, MD, PhD, Joslin Diabetes Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 12, 2016

Study Record Updates

Last Update Posted (Actual)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 28, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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