Effects of Walnut Consumption on Endothelial Function in Type 2 Diabetes

Completed · Not applicable

Conditions studied: DIABETES MELLITUS TYPE 2

In brief

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.

Key facts

Study ID

NCT00901043

Run by

Griffin Hospital

People needed

24

Starts

2007-10-01

Expected to finish

2008-09-01

Last updated by the study team

2020-03-26

Who can join

Age: 35 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Griffin Hospital — Derby, Connecticut, United States

Full record on ClinicalTrials.gov

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