Type 2 Diabetes
Conditions
Brief summary
The purpose of this study is to evaluate the effect of medically-tailored meal delivery (10 meals per week for 3 months) on glycemic control in diabetic patients.
Interventions
DIETARY_SUPPLEMENTMedically tailored meals
10 meals per week for 3 months
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult men and women with non-insulin dependent diabetes. * Ages 25 to 75 years. * Fasting blood sugar of greater than 140 mg/dl, on no oral hypoglycemic agents and a hemoglobin A1C less than 13%. * Stabilized patients on oral hypoglycemic agents for one month or longer prior to starting the study and a hemoglobin A1C between 7.5% - 13%.
Exclusion criteria
* Insulin use. * Substance abuse. * Any documented medical problem that would inhibit full participation in the study. * BMI less than 25 or great than 40. * Vegans or Vegetarians * Individuals with food allergies. * Individuals currently on a commercial weight loss or diet program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glucose Metabolism | Baseline, 3 monts | Measured by HbA1c levels in standard chemistry in blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | Baseline, 3 months | Measured in killograms |
| Change in Blood Pressure | Baseline, 3 months | Measured in units of millimeters of mercury (mmHg) |
| Change in High Density lipoprotein (HDL) | Baseline, 3 months | HDL cholesterol levels measured by standard chemistry in blood reported in units of milligrams per deciliter (mg/dL) |
| Change in Low Density Lipoprotein (LDL) | Baseline, 3 months | LDL cholesterol levels measured by standard chemistry in blood reported in units of milligrams per deciliter (mg/dL) |
| Change in Triglycerides | Baseline, 3 months | Triglyceride levels measured by standard chemistry in blood reported in units of milligrams per deciliter (mg/dL) |
Countries
United States
Outcome results
None listed