Polyphenols and Insulin Resistance (POLYOXRESIST)
This study has been completed.
Sponsor:
University Hospital, Montpellier
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01478841
First received: November 21, 2011
Last updated: February 10, 2012
Last verified: February 2012
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Purpose
Diet and nutrition play an essential role in the development and the clinical expression of the most common health problems. Overeating and obesity induce oxidative stress, which has been proposed to be a pathogenic mechanism leading to insulin resistance, type 2 diabetes (T2D) and associated cardiovascular complications. The main objective of the proposed research is to evaluate the beneficial effects of polyphenolic compounds derived from red grape marc extracts on the cascade of events leading from overeating to oxidative stress and insulin resistance. For that, we will study free radicals production, inflammatory markers, adipokines, mitochondrial function, insulin sensitivity and energy substrate utilization in healthy volunteers at risk for insulin resistance and T2D (1st degree relatives of T2D patients with associated overweight). These volunteers will be randomized between a placebo and a polyphenol group for 9 weeks. The demonstration of the beneficial effects of polyphenols will be sensitized by high-fructose feeding for the last 6 days of the protocol.
| Condition | Intervention |
|---|---|
|
Healthy Volunteers Insulin Resistance Type 2 Diabetes (T2D) |
Drug: polyphenol Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | INFLUENCE OF POLYPHENOLS ON OXIDATIVE STRESS IN HEALTHY INDIVIDUALS WITH HIGH METABOLISM RISK: RELATIONSHIP WITH THE MECHANISMS OF INSULIN RESISTANCE |
Resource links provided by NLM:
Further study details as provided by University Hospital, Montpellier:
Primary Outcome Measures:
- Peripheral insulin-sensitivity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- biochemical parameters [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 44 |
| Study Start Date: | October 2008 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Polyphenols
9 weeks of supplementation with polyphenols(D56) and during the last week supplementation with polyphenols associated with a fructose load during the last 6 days (D63).
|
Drug: polyphenol
2 capsules of 0.5 gram to be taken at the beginning of breakfast and dinner (2g/day) fructose : dose of 3 g/kg/day from D57 to D62 in the form of a 20% solution taken during the three main meals
|
|
Placebo Comparator: placebo
9 weeks of supplementation with placebo (D56) and during the last week supplementation with placebo associated with a fructose load during the last 6 days (D63).
|
Drug: placebo
2 capsules of 0.5 gram to be taken at the beginning of breakfast and dinner (2g/day) fructose : dose of 3 g/kg/day from D57 to D62 in the form of a 20% solution taken during the three main meals
|
Eligibility| Ages Eligible for Study: | 30 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Absence of anti HIV or anti hepatitis C antibodies and of HBS antigen.
- Acceptable biological assessment of the hepatic and renal functions (γGT, ALAT, ASAT < 3 times the normal value and serum creatinine <150 micromol/l).
- Age between 30 and 55 years.
- Fasting plasma glucose <110 mg/dl and absence of any anti-diabetic treatment
- No regular physical activity (Voorips index < 9)
- Absence of any drug treatment in progress and during the last 2 months
- Subjects with at least one 1st degree relative with T2D and with a body mass index between 25 and 35 kg/m² and a waist measurement >94 cm for males, and >80 cm for females.
- Normal ionogram (sodium 135 - 145 mmol/l, potassium 3,5 - 4,5 mmol/l).
- Normal ferritin level (75 - 300 ng/ml)
- hs-CRP <8 mg/l.
- Absence of arterial hypertension (systolic pressure <140 mmHg and diastolic pressure <90 mmHg).
- Non smoker or former smoker (quit smoking >1 year).
- Alcohol consumption <30 g/day.
Exclusion Criteria:
- Hyperthermia (T°>38°c)
- Subject deprived of freedom by a court or administrative order
- Major protected by the law
- Subject who is in a period of relative exclusion due to his/her participation to another protocol or for whom the annual maximum amount of allowances of 3 811.23 € is reached.
- Subject who has been treated with anti-coagulants, anti-inflammatory drugs, b-blockers or insulin during the last month.
- Subject who cannot be subjected to muscle biopsy.
- Allergy to the anaesthetic
- Woman in age to procreate and not taking any oral or intra-uterine contraception
Contacts and Locations More Information
No publications provided
| Responsible Party: | University Hospital, Montpellier |
| ClinicalTrials.gov Identifier: | NCT01478841 History of Changes |
| Other Study ID Numbers: | UF8178 |
| Study First Received: | November 21, 2011 |
| Last Updated: | February 10, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Montpellier:
|
insulin resistance type 2 diabetes (T2D) cardiovascular complications polyphenolic compounds derived from red grape marc extracts oxidative stress |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Insulin Resistance Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Hyperinsulinism Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013