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Completed

NCT Number: NCT00951392

Implication of Metabolic and Genomic Modifications in Elderly Subjects

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.

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Key information

Conditions

Insulin Sensitivity Aging Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche en nutrition humaine Rhône-Alpes

Pierre-Bénite, 69495, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

euglycemic hyperinsulinemic clamp

Drug

Insulin perfusion at 1 mU.kg-1.min-1

Glucose perfusion to maintain euglycemia at 5,0 ± 0,5 mmol/l

Blood tests

Muscle biopsy

Procedure

Gene expression in muscle tissue will be studied with two approaches :

  • Candidate gene approach by quantitative RT-PCR : genes involved in the carbohydrates and lipids metabolism including lipid oxidation in muscle (lipid carriers, PPARs), expression of 7 sirtuins isoforms as well as some of their target genes (NFkB, PGC1a)
  • Global transcriptome analysis by DNA Chip

Indirect calorimetry

Device

energy expenditure measurement

Primary outcomes

  1. Comparison of metabolic profile (lipid metabolism and energy expenditure) and insulin sensitivity based on the aging quality

    Time frame: 120 minutes

Secondary outcomes

  1. Gene expression in muscle tissue by quantitative RT-PCR: genes involved in the carbohydrates and lipids metabolism (lipid carriers, PPARs), 7 sirtuins isoforms and of their target genes (NFkB, PGC1a)

    Time frame: one day

  2. Gene expression in muscle tissue by Global transcriptome analysis by DNA Chip

    Time frame: one day

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: COMPALICLAMP

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 4, 2009
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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