Clinical trial NCT02896140: Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk Factors
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Obesity
Keywords: Type 2 diabetes
Obesity
Nutrition
Dairy
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants in Joslin Diabetes Center's Weight Achievement and Intensive Treatment (Why WAIT) program

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hemoglobin A1C (A1C)
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in body weight
timeFrame: 24 weeks
measure: Change in low-density lipoprotein (LDL)
timeFrame: 24 weeks
measure: Change in high-density lipoprotein (HDL)
timeFrame: 24 weeks
measure: Change in total cholesterol
timeFrame: 24 weeks
measure: Change in triglycerides
timeFrame: 24 weeks
measure: Change in fasting plasma glucose
timeFrame: 24 weeks
measure: Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index
timeFrame: 24 weeks
measure: Height in meters
timeFrame: 24 weeks
measure: Change in body fat percentage
timeFrame: 24 weeks
measure: Change in fat free mass
timeFrame: 24 weeks
measure: Change in total body water
timeFrame: 24 weeks
measure: Change in waist circumference
timeFrame: 24 weeks
measure: Change in trunk fat percentage
timeFrame: 24 weeks
measure: Change in visceral fat level
timeFrame: 24 weeks
measure: Change in blood pressure
timeFrame: 24 weeks
measure: Change in c-reactive protein level
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Osama Hamdy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: