View Clinical Trial (Medical Research Study)
Resveratrol-Leucine Metabolite Synergy in Pre-diabetes
| City: |
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Nashville |
| State: |
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Tennessee |
| Zip Code: |
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37232 |
| Conditions: |
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Impaired Glucose Tolerance |
| Purpose: |
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The study will evaluate the effects of resveratrol/leucine and resveratrol/HMB for their
ability to control glucose levels in persons without diabetes but with impaired fasting
glucose. Secondary assessments will examine the effect of these nutritional supplements
versus placebo on inflammation, fasting lipids, HbA1C, and fructosamine, longer term
metabolic markers of risk in diabetes.
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| Study Summary: |
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This will be a 28-day randomized controlled trial of the effects of a nutraceutical
preparation on glycemic control in non-diabetic individuals with impaired glucose tolerance
(IGT). IGT will be defined by American Diabetes Association criteria, as outlined in the
list of inclusion and exclusion criteria (copy attached). There will be two active
treatment arms and a placebo arm (3 arms total, n=12 completed subjects per arm). Following
screening for inclusion/exclusion criteria and obtaining informed consent, subjects will be
enrolled in the study and provided instructions to maintain their usual dietary pattern and
physical activity level. If recent physical examination and medical history are not
available; H&P will be conducted and recorded for each enrolled subject. Subjects will be
instructed to follow a 12-hour fast starting on day -1, and on the morning of day 0 fasting
blood is drawn for analyses indicated below and the supplements are distributed.
Supplements are distributed using a blinding protocol and a variable, known pill allotment
in order to assess compliance via standard pill counts. Pill bottles and all unused
supplements are returned at seven day intervals, with new supplies being distributed at that
time. Fasting blood samples are obtained on days 0, 7, 14 and 28. Samples from each day
are analyzed for glucose and insulin. Samples from days 0, 14 and 28 are also analyzed for
fructosamine, C-peptide, glucagon and F2-isoprostanes. A75 g oral glucose tolerance test
administered on days 0 and 28.
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| Criteria: |
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Inclusion Criteria:
- Impaired fasting glucose as defined by American Diabetes Association criteria:
fasting plasma glucose level from 5.6 mmol/L (100 mg/dL) to 6.9 mmol/L (125 mg/dL)
- Body mass index (BMI) 25-34.9
- Age 18 and above• Weight stable: no more than 1 kg weight gain or loss during past 12
weeks
Exclusion Criteria:
- Fasting glucose >126 or <99 mg/dL
- BMI < 25 or >35
- Current/previous diagnosis of diabetes
- History of eating disorder or presence of active gastrointestinal disorders such as
malabsorption syndromes
- Pregnancy or lactation Anemia, defined as hemoglobin level less than 10g/dl.
- Use of obesity pharmacotherapeutic agents within the last 6 months
- Use of over-the-counter anti-obesity agents (e.g. those containing
phenylpropylamine , ephedrine and/or caffeine) within the last 3 months
- Chronic use of anti-inflammatory agents within the last four weeks
- Use of antioxidant supplements within the last four weeks including selenium, vitamin
E, vitamin C and/or carotenoids
- Use of supplements containing any of the study compounds within the past four weeks
- Recent (current or past 12 weeks) use of any psychotropic medication
- Recent (past four weeks) initiation of or change in an exercise program
- Recent (past twelve weeks) initiation of hormone replacement therapy or change in HRT
regimen
- Recent (past twelve weeks) initiation of hormonal birth control or change in hormonal
birth control regimen
- Recent (past 12-weeks) history of tobacco use
- Any Condition that the P.I. considers adverse to the participant
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| NCT ID: |
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NCT01593605 |
| Primary Contact: |
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Principal Investigator
Kevin D Niswender, MD,PHD
Vanderbilt University School of Medicine
Wanda Snead, Dr.HSc
Phone: 615-936-1625
Email: wanda.snead@vanderbilt.edu
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| Backup Contact: |
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Email: libby.stone@vanderbilt.edu
Libby Stone, RN
Phone: 615-936-1149
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| Location Contact: |
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Nashville, Tennessee 37232
United States
Wanda L. Snead, Dr.HSc
Phone: 615-936-1625
Email: wanda.snead@vanderbilt.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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