Effects of Pistachios on Cardiovascular Responses to Stress in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is investigating the effects of three different diets, including a diet with pistachios, on cardiovascular disease risk markers in people with type 2 diabetes.

Detailed Description
-----------------
The study will last 12-16 weeks and requires 10-13 visits to the General Clinical Research Center on the University Park campus. All food and snacks will be provided for 10 weeks. At the end of each of three diet periods, participants will undergo a test of endothelial function, an oral glucose tolerance test, and a cardiovascular stress reactivity test.

Official Title
-----------------
Effects of Pistachios on Cardiovascular Responses to Stress in Type 2 Diabetes: A Novel Intervention for a High Risk Population

Conditions
-----------------
Cardiovascular Disease, Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: Pistachio


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, nonsmoking adults, aged 30-75 years (women must be post-menopausal) Diagnosed with Type 2 diabetes Exclusion Criteria: Insulin, more than one blood pressure lowering medication, daily aspirin, NSAID therapy, oral steroids within the last 6 weeks, oral contraceptives, and hormone replacement therapy Chronic disease such as cardiovascular disease or any complications of diabetes (retinopathy, neuropathy, etc). Allergies or aversions to pistachios Unwillingness to consume all foods provided and no other meals or snacks for the 10 weeks of diet intervention

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pistachio Diet<br>Incorporates 3.0 oz (2 servings) of pistachios into a daily diet | Other: Pistachio<br>* 3.0 oz (2 servings) of roasted and salted or unsalted pistachios<br>|
| No Intervention: Non-Pistachio<br>Does not incorporate pistachios into a daily diet | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular responses to stress |  | End of each diet period | 
| Insulin sensitivity and resistance |  | End of each diet period | 
| Lipids and lipoproteins |  | End of each diet period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular endothelial function |  | End of each diet period | 
| Mood and perceived stress |  | End of each diet period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular Disease, Type II Diabetes, Nutrition, Pistachios, Cardiovascular disease risk factors in adults with Type II diabetes