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NCT Number: NCT02896140

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Subject is pregnant or lactating
  • Subject has a heart pacemaker

Treatment and study plan

Type 2 diabetes in WhyWAIT Program

Other

The sum of servings per day of milk, cheese, yogurt, and other dairy foods.

Primary outcomes

  1. Change in Hemoglobin A1C (A1C)

    Time frame: 24 weeks

Secondary outcomes

  1. Change in body weight

    Time frame: 24 weeks

  2. Change in low-density lipoprotein (LDL)

    Time frame: 24 weeks

  3. Change in high-density lipoprotein (HDL)

    Time frame: 24 weeks

  4. Change in total cholesterol

    Time frame: 24 weeks

  5. Change in triglycerides

    Time frame: 24 weeks

  6. Change in fasting plasma glucose

    Time frame: 24 weeks

  7. Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index

    Time frame: 24 weeks

  8. Height in meters

    Time frame: 24 weeks

  9. Change in body fat percentage

    Time frame: 24 weeks

  10. Change in fat free mass

    Time frame: 24 weeks

  11. Change in total body water

    Time frame: 24 weeks

  12. Change in waist circumference

    Time frame: 24 weeks

  13. Change in trunk fat percentage

    Time frame: 24 weeks

  14. Change in visceral fat level

    Time frame: 24 weeks

  15. Change in blood pressure

    Time frame: 24 weeks

  16. Change in c-reactive protein level

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2016
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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