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Implication of Metabolic and Genomic Modifications in Elderly Subjects (COMPALICLAMP)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Aging
Insulin Sensitivity

Treatments

Procedure: muscle biopsy
Drug: euglycemic hyperinsulinemic clamp
Device: indirect calorimetry

Study type

Interventional

Funder types

Other

Identifiers

NCT00951392
2008.547

Details and patient eligibility

About

An increase of longevity and of the number of men and women older than 60 years old is observed in most industrialized countries. Aging is a complex, multifactorial and continuous process involving physical and biological modifications such as a notably decrease in glucose tolerance and type 2 diabetes risk. Insulin sensitivity follow-up during aging is difficult mainly because of many confounding factors (environment, lifestyle).

In 2006, SUVIMAX 2 study began, based on the monitoring of volunteers who participated in former SUVIMAX study (1994-2003). This study was a randomised trial which was designed to study the link between a low antioxidant intake and risk of cancer or ischemic heart disease. The subjects recently had a health check-up including complete information about their diet, physical and neurosensory status. Based on these data, a score was established to classify subjects according to their quality of aging ("successful aging versus "problematic aging") These volunteers, who undertook a 13-year follow-up (dietary and medical status), constitute the reference population to determine the mechanisms involved in the insulin resistance development in aging.

The purpose of our research work is to determine whether the quality of aging could influence insulin sensitivity, by studying metabolic profile and change in gene expression (genes involved in glucose metabolism and metabolic senescence in muscle tissue) during aging.

Enrollment

35 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Volunteers from the cohort aging SUVIMAX 2
  • Men and Women
  • over 60 years
  • BMI between 18 and 35 kg/m2 (including terminals)
  • Normal medical check up
  • Blood pressure < 140/90 mmHg
  • Normal glycemia, lipid profile
  • sedentary or moderate physical activity (maximum 4 hours per week)

Exclusion criteria

  • Biological results or anormal chek-up
  • medical or surgical history not compatible with study
  • severe digestive, cardiovascular, renal, liver or tumor disorders history in the 5 last years
  • infectious or inflammatory disease within 2 months
  • surgical history within 3 months
  • bood donation within 2 months
  • coagulation disease, anticoagulant or antiplatelet agents (aspirin ...) treatment
  • xylocaïn allergy
  • claustrophobia
  • Drug that could affect insulin sensitivity (beta blockers, lipid lowering, oral antidiabetics, insulin, , steroids)

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

35 participants in 2 patient groups

Problematic aging
Experimental group
Treatment:
Device: indirect calorimetry
Procedure: muscle biopsy
Drug: euglycemic hyperinsulinemic clamp
successful aging
Experimental group
Treatment:
Device: indirect calorimetry
Procedure: muscle biopsy
Drug: euglycemic hyperinsulinemic clamp

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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