Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk Factors
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
1 other identifier
observational
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 26, 2016
CompletedFirst Posted
Study publicly available on registry
September 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedMarch 1, 2019
February 1, 2019
2.2 years
April 26, 2016
February 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Hemoglobin A1C (A1C)
24 weeks
Secondary Outcomes (16)
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
- +11 more secondary outcomes
Study Arms (1)
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).
Interventions
The sum of servings per day of milk, cheese, yogurt, and other dairy foods.
Eligibility Criteria
Participants in Joslin Diabetes Center's Weight Achievement and Intensive Treatment (Why WAIT) program
You may qualify if:
- 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
You may not qualify if:
- Subject is pregnant or lactating
- Subject has a heart pacemaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Biospecimen
Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Osama Hamdy, MD, PhD
Joslin Diabetes Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2016
First Posted
September 12, 2016
Study Start
April 1, 2016
Primary Completion
July 1, 2018
Study Completion
September 1, 2018
Last Updated
March 1, 2019
Record last verified: 2019-02