Clinical trial NCT01593605: Resveratrol-Leucine Metabolite Synergy in Pre-diabetes
Official title: Resveratrol-Leucine Metabolite Synergy in Pre-diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Glucose Tolerance
Keywords: Impaired glucose tolerance, pre-diabetes,glycemic control,
supplements
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Nutraceutical Discoveries, Inc.
First posted: 2012-05-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Glucose Control
timeFrame: 28 days
Secondary outcomes:
measure: Metabolic Markers
timeFrame: 28 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University School of Medicine
name: Kevin D Niswender, MD,PHD
role: PRINCIPAL_INVESTIGATOR
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