Clinical trial NCT02114892: Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Official title: Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metabolic Syndrome X
Keywords: metabolic syndrome
central obesity
resveratrol
insulin secretion
insulin sensitivity
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.

Resveratrol is a substance found in many plants, including grapes, nuts and wine, but it's also found in Polygonum cuspidatum. There is evidence that resveratrol consumption has beneficial effects on glucose and lipids metabolism, blood pressure and body weight.

The aim of this study was to evaluate the effect of resveratrol on metabolic syndrome, insulin sensitivity and insulin secretion.

The investigators hypothesis was that the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

Detailed description: A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric were evaluated after a 75 g of dextrose load.

12 received resveratrol, 500 mg, three times per day (1500 mg) before meals during 3 months.

The remaining 12 patients received placebo with the same prescription.

Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).

This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.

Results are presented as mean and standard deviation. Intra and inter group differences were tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was considered significant.

Eligibility criteria: Inclusion Criteria:

* Patients both sexes
* Age between 30 and 50 years
* Metabolic Syndrome according to the IDF criteria
* Waist circumference
* Man ≥90 cm
* Woman ≥80 cm
* And two of the following criteria:
* High density lipoprotein
* Man ≤40 mg/dL
* Woman ≤50 mg/dL
* Fasting glucose ≥100 mg/dL
* Triglycerides ≥150 mg/dL
* Blood pressure ≥130/85 mmHg
* Informed consent signed

Exclusion Criteria:

* Women with confirmed or suspected pregnancy
* Women under lactation and/or puerperium
* Hypersensibility to resveratrol
* Physical impossibility for taking pills
* Known uncontrolled renal, hepatic, heart or thyroid diseased
* Previous treatment for the metabolic syndrome components
* Body Mass Index ≥39.9 kg/m2
* Fasting glucose ≥126 mg/dL
* Triglycerides ≥500 mg/dL
* Total cholesterol ≥240 mg/dL
* Low density lipoprotein (c-LDL) ≥190 mg/dL
* Blood Pressure ≥140/90 mmHg

Primary outcomes:
measure: Triglycerides Levels at Week 12
timeFrame: Week 12
measure: High Density Lipoprotein (c-HDL) Levels at Week 12.
timeFrame: Baseline. Week 12
measure: Fasting Glucose Levels at Week 12.
timeFrame: Week 12
measure: Systolic Blood Pressure at Week 12.
timeFrame: Week 12
measure: First Phase of Insulin Secretion at Week 12.
timeFrame: Week 12
measure: Total Insulin Secretion at Week 12.
timeFrame: Week 12
measure: Total Insulin Sensitivity at Week 12.
timeFrame: Week 12
measure: Waist Circumference at Week 12
timeFrame: Week 12
measure: Diastolic Blood Pressure at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Weight at Week 12.
timeFrame: Week 12
measure: Body Mass Index at Week 12
timeFrame: Week 12
measure: Total Cholesterol at Week 12
timeFrame: Week 12
measure: Low Density Lipoproteins (c-LDL) at Week 12
timeFrame: Week 12
measure: Creatinine at Week 12.
timeFrame: Baseline. Week 12.
measure: Uric Acid at Week 12.
timeFrame: Week 12.
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: MANUEL GONZALEZ, PhD
role: PRINCIPAL_INVESTIGATOR
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