Status:

COMPLETED

Polyphenols and Insulin Resistance

Lead Sponsor:

University Hospital, Montpellier

Conditions:

Healthy Volunteers

Insulin Resistance

Eligibility:

All Genders

30-55 years

Phase:

NA

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2012

Estimated Enrollment :

44 Patients enrolled

Trial Details

Trial ID

NCT01478841

Start Date

October 1 2008

End Date

January 1 2012

Last Update

February 13 2012

Active Locations (1)

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1

Montpellier University Hospital

Montpellier, France, 34295