Type 2 Diabetes
Conditions
Brief summary
This is a randomized prospective clinical study in patients with type 2 diabetes to evaluate the effect of dairy products with full or low fat on glycemic control and cardio-metabolic risk factors in comparison to a regular diet.
Detailed description
This is a randomized, controlled clinical study in which 108 subjects with type 2 diabetes will be randomized into 3 different groups: Full fat dairy group (Group A): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of full fat dairy products into their diet Low fat dairy group (Group B): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of low fat dairy products into their diet Control group (Group C): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products Subjects in Groups A and B will be educated about different dairy products' serving sizes and fat content. Subjects in all 3 groups will be asked to record their daily intake of dairy products in a dedicated log book. Subjects randomized to groups A and B will be asked to only use only dairy products with either the full fat or and low (≤1%) fat dairy (≤1% fat content) content respectively. Purchase of the dairy products will be the responsibility of study subjects for which a subsidy of $500 (about $20/week for 24 weeks) will be provided for each subject. All study participants will also be asked to record their food intake for 3 days before each study visit in a 3-day food log.
Interventions
OTHERFull fat dairy
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of full fat dairy products into their diet
OTHERLow fat dairy
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of low fat dairy products into their diet
OTHERControl
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products
Sponsors
Joslin Diabetes Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Having type 2 diabetes for at least three months prior to screening and treated with any antihyperglycemic medication * A1C ≥7 % * Consuming \<3 servings of dairy products per day * On stable dose of diabetes, blood pressure or cholesterol medications for 3 months * Body weight is within 10% of current weight over the last 6 months before starting the study
Exclusion criteria
* Pregnancy or lactation * Lactose intolerance * Allergy to milk or any of its components * Use of orlistat * History of pancreatitis * History of gastric bypass surgery or sleeve gastrectomy * Active malignancy * History of recent cardiovascular event * Having a heart pacemaker * Enrollment in other studies that may affect study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hemoglobin A1C (A1C) | Baseline, 12 weeks and 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | Baseline, 12 weeks and 24 weeks | — |
| Change in total cholesterol | Baseline, 12 weeks and 24 weeks | — |
| Change in high-density lipoprotein (HDL) | Baseline, 12 weeks and 24 weeks | — |
| Change in low-density lipoprotein (LDL) | Baseline, 12 weeks and 24 weeks | — |
| Change in triglycerides | Baseline, 12 weeks and 24 weeks | — |
| Change in fasting plasma glucose | Baseline, 12 weeks and 24 weeks | — |
| Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index after 24 weeks compared to baseline | Baseline, 12 weeks and 24 weeks | — |
| Change in body fat percentage | Baseline, 12 weeks and 24 weeks | — |
| Change in fat free mass | Baseline, 12 weeks and 24 weeks | — |
| Height in meters | Baseline | Used in calculation of Body Mass Index |
| Change in total body water | Baseline, 12 weeks and 24 weeks | — |
| Change in waist circumference | Baseline, 12 weeks and 24 weeks | — |
| Change in trunk fat percentage | Baseline, 12 weeks and 24 weeks | — |
| Change in visceral fat level | Baseline, 12 weeks and 24 weeks | — |
| Change in blood pressure | Baseline, 12 weeks and 24 weeks | — |
| Change in c-reactive protein level | Baseline, 12 weeks and 24 weeks | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOROsama Hamdy, M.D., Ph.D.
Joslin Diabetes Center
Outcome results
None listed