Clinical trial NCT00951392: Implication of Metabolic and Genomic Modifications in Elderly Subjects
Official title: Implication of Metabolic and Genomic Modifications in Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Aging
Keywords: Insulin sensitivity
aging
lipid metabolism
hyperinsulinemic clamp
gene expression
sirtuins
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2009-08-04
Enrollment: 35
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Comparison of metabolic profile (lipid metabolism and energy expenditure) and insulin sensitivity based on the aging quality
timeFrame: 120 minutes
Secondary outcomes:
measure: 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)
timeFrame: one day
measure: Gene expression in muscle tissue by Global transcriptome analysis by DNA Chip
timeFrame: one day
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre de recherche en nutrition humaine Rhône-Alpes
Study officials:
affiliation: Centre de Recherche en Nutrition Humaine Rhône-Alpes
name: Martine LAVILLE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Betry C, Meugnier E, Pflieger M, Grenet G, Hercberg S, Galan P, Kesse-Guyot E, Vidal H, Laville M. High expression of CPT1b in skeletal muscle in metabolically healthy older subjects. Diabetes Metab. 2019 Apr;45(2):152-159. doi: 10.1016/j.diabet.2018.01.018. Epub 2018 Feb 12.