Study of Raisins Versus Alternative Snacks in Patients With Type 2 Diabetes Mellitus

Completed · Phase 4

Conditions studied: Diabetes Mellitus

In brief

The objective of this study is to compare the effects of Raisins three times per day versus alternative snacks three times per day on blood sugar control and cardiovascular risk factors (weight, waist circumference, blood pressure, cholesterol levels) in patients with Type 2 Diabetes Mellitus. These effects will be studied over a 12 week period.

Key facts

Study ID

NCT01677936

Run by

Louisville Metabolic and Atherosclerosis Research Center

People needed

51

Starts

2012-06-01

Expected to finish

2014-01-01

Last updated by the study team

2014-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Are generally healthy men and women older than 18 years of age
• Are willing and able to undergo an informed consent process
• Have medical history of Type 2 Diabetes Mellitus
• Have hemoglobin A1c 67.5 - 10%
• Have body mass index (BMI) 25.0 to 39.9 kg/m2
• Have blood pressure > 100 mmHg systolic or > 70 mmHg diastolic
• Are willing and able to perform self-glucose monitoring throughout the study
• Are willing to fast before study visits
• Are willing and able to bring in their morning anti-diabetes mellitus drugs to study visits
• Women must be of non-childbearing potential defined as postmenopausal for at least 2 years or surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
• If not menopausal or surgically sterile, then women of child-bearing potential must be willing to use:
• oral contraceptives and another acceptable form of birth control, or
• double barrier birth control methods such as condom or occlusive cap (e.g. diaphragm or cervical/vault caps) plus spermicidal agent (e.g. foam, gel, film, cream, suppository).
• Are willing to notify the research staff of any change in their medical health \& concomitant medications/supplements during the course of the clinical trial

You may not qualify if…

• Intolerance, dislike, or unwillingness to consume raisins or any of the comparator snacks and affiliated ingredients
• History of greater than one drug allergy
• History of greater than one "food allergy"
• Change in anti-diabetes mellitus medication within 3 months prior to screening visit
• Change in blood pressure and/or lipid-altering medications within 1 month of screening visit
• Plans to change current anti-diabetes mellitus, blood pressure, or lipid-altering medications during course of the study
• Unwilling to maintain current anti-diabetes mellitus, blood pressure, or lipid-altering medications and their doses during the course of the study
• History of clinically significant diabetes mellitus complications, that in the opinion of the investigator, may interfere with the successful completion of the trial
• History of clinically significant diabetes mellitus kidney disease (e.g. clinically significant proteinuria)
• History of severe high or low blood sugars within the past year, as per Investigator discretion
• History of severe high or low blood sugars requiring hospitalization at any time in the past
• Subjects are excluded if within the past 6 months, they have history of myocardial infarction, acute coronary syndrome, stroke, or any cardiac / vascular surgical procedure (e.g. atherosclerotic coronary heart disease by-pass, carotid surgery, peripheral vascular by-pass, stent placement, pacemaker placement, etc.), unstable angina, or alterations in treatment of stable angina
• Subjects are excluded if at any time in the past, they have history of clinically significant ventricular or atrial dysrhythmias
• Subjects are excluded if at any time in the past, they have history of New York Heart Association (NYHA) functional heart failure of Class III or greater, defined as: CLASS III: Marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes fatigue, palpitations or dyspnea, CLASS IV: Unable to carry out any physical activity without discomfort, symptoms of cardiac insufficiency at rest, if any physical activity is undertaken, discomfort is increased
• Subjects are excluded if at any time in the past, they have history of or known increases in QTc
• History of seizures in the past year
• Is pregnant, breastfeeding or plans to become pregnant during the course of the clinical trial
• Major surgical procedure within 30 days prior to visit #1 (i.e. day of signing of the informed consent document), or current plans to have a major surgical procedure during study participation or 30 days following completion of all study related procedures
• History of gastrointestinal malabsorption (e.g. uncontrolled crohn's disease, etc.) or history of a gastric bypass or other diversional bariatric surgery. Gastric banding procedure is also exclusionary if adjusted within 30 days prior to visit #1 (i.e. day of signing the informed consent document), or a reasonable chance of having a gastric banding adjustment during the course of the study
• History of ongoing malignancy. History of malignancy is acceptable for eligibility if successfully treated, with no evidence of persistence or recurrence of the malignancy within 5 years of visit #1 (i.e. day of signing the informed consent document) or basal carcinoma of the skin and "in situ" cancer of the cervix successfully treated 30 days prior to visit #1
• History of organ transplant.
• History of drug (licit or illicit) or alcohol abuse/addiction within 5 years of visit #1 (i.e. day of signing the informed consent document)
• Routinely consumes more than 2 units of alcohol per day. A unit of alcohol is defined as a 12 ounce (350 ml) beer, 5 ounce (150 ml) wine, or 1.5 ounce (45 ml) of 80-proof alcohol for mixed drinks.
• History of clinically significant heart, vascular, hematologic, orthopedic, rheumatologic, muscle, brain, neurologic (e.g. dementia, uncontrolled seizure disorder, etc.) , gastrointestinal (such as chronic hepatitis B or C, malabsorptive intestinal diseases such as uncontrolled crohn's disease, ulcerative colitis, severe irritable bowel syndrome, other significant gastrointestinal diseases that may interfere with study participation and/or results), endocrine (uncontrolled hyper or hypothyroidism), ophthalmologic, infectious (e.g. human immunodeficiency virus, tuberculosis, etc.) immunologic, nephrologic, pulmonary (e.g. poorly controlled asthma, poorly controlled chronic obstructive pulmonary disease, dyspnea, etc.), dermatologic, reproductive, psychiatric (e.g. bipolar disorder, schizophrenia, borderline personality disorder, etc.) disorders, or any other conditions that would present unacceptable risk to study subjects, compromise the acquisition or interpretation of study data, or otherwise interfere with the study subject's participation in the study.
• History of severe or uncontrolled depression based upon the opinion of the Principal Investigator.

Where it is running

• L-MARC Research Center — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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