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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk in Patients With Type 2 Diabetes

NCT02895867

Type 2 Diabetes

COMPLETED NA

Dairy Products, Diabetes and Genetics

NCT02961179

Insulin Sensitivity Type2 Diabetes

COMPLETED NA

Effect of a Dietary Intervention on Intracellular Lipid Levels, Insulin Sensitivity, and Glycemic Control in Type 2 Diabetes

NCT04088981

Diabetes Mellitus, Type 2

WITHDRAWN NA

Yoghurt Consumption, Body Weight Management and Glycemic Control of T2DM Patients

NCT03926806

Type 2 Diabetes Mellitus

COMPLETED NA

Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

NCT01925248

Type 2 Diabetes Mellitus Hyperglycemia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2 Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Type 2 diabetes in WhyWAIT Program

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Type 2 diabetes in WhyWAIT Program

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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