Status:
COMPLETED
Effects of Walnut Consumption on Endothelial Function in Type 2 Diabetes
Lead Sponsor:
Griffin Hospital
Collaborating Sponsors:
California Walnut Commission
Conditions:
DIABETES MELLITUS TYPE 2
Eligibility:
All Genders
35-75 years
Phase:
NA
Brief Summary
The purpose of this study is to examine the effects of sustained walnut consumption on endothelial function and lipid markers in patients with Type 2 diabetes mellitus.
Detailed Description
Evidence-based guidelines for the management of type 2 diabetes mellitus and related cardiovascular disease (CVD) refer to cardioprotective dietary fatty acid proportions. Several studies demonstrate ...
Eligibility Criteria
Inclusion
- men and women ages 35-75
- non-smoker
- able to have blood pressure taken bilaterally
- diagnosed with type 2 diabetes by physician for at least one year
- stable glucose levels and medication dose for the past 3 months
- not on insulin therapy
Exclusion
- failure to meet inclusion criteria
- anticipated inability to complete or comply with study protocol for any reason (e.g., inability to communicate in English, dementia) or any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., wasting illness, AIDS, tuberculosis, psychotic disorder)
- diagnosed eating disorder
- use of lipid-lowering or antihypertensive medications (statins, red rice yeast extract, garlic) unless stable on medication for at least 3 months and willing to refrain from taking medication for 12 hours prior to endothelial function (EF) scanning, vasoactive medication (i.e., glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators) or nutriceuticals
- regular use of multivitamins and/or complementary or alternative supplement therapy and unwillingness to discontinue supplementation for at least 8 weeks prior to study initiation and for study duration
- any rheumatologic disease requiring regular use of nonsteroidal antiinflammatory drug (NSAIDs) or alternative medications
- regular use of fiber supplements
- preexisting cardiovascular disease, including symptomatic coronary artery disease (CAD), myocardial infarction, angina pectoris, anginal equivalent, peripheral vascular disease (claudication, amputation, or revascularization) congestive heart failure, carotid stenosis, aortic stenosis or stroke; diabetes, sleep apnea, severe uncontrolled hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 105 mmHg)
- coagulopathy, known bleeding diathesis or history of clinically significant hemorrhage; current use of warfarin
- clinically significant anemia (Hct \< 36% in men, \< 33% in women)
- intestinal or stomach disease
- inability to use right or left arm for endothelial function testing for any reason such as breast surgery, trauma, radiation to right axilla, lymphedema, right arm shunt, severe vascular disease in right arm
- subjects on a disease specific diet
- subjects on a weight control diet
- subjects on a vegan diet
- allergy to any kind of nut, including walnuts and peanuts
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00901043
Start Date
October 1 2007
End Date
September 1 2008
Last Update
March 26 2020
Active Locations (1)
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1
Griffin Hospital
Derby, Connecticut, United States, 06418