Implication of Metabolic and Genomic Modifications in Elderly Subjects

Aging Clinical Trial

— COMPALICLAMP  

Official title:

Implication of Metabolic and Genomic Modifications in Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951392
• Other study ID #: 2008.547
• Status: Completed
• Phase: N/A
• Start date: May 2009
• Est. completion date: November 2009

Study information

• Verified date: March 2010
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aging
• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity

Intervention

Drug:
• euglycemic hyperinsulinemic clamp
Insulin perfusion at 1 mU.kg-1.min-1 Glucose perfusion to maintain euglycemia at 5,0 ± 0,5 mmol/l Blood tests

Procedure:
• muscle biopsy
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

Device:
• indirect calorimetry
energy expenditure measurement

Locations

Country	Name	City	State
France	Centre de recherche en nutrition humaine Rhône-Alpes	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

Bétry 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.2018.01.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of metabolic profile (lipid metabolism and energy expenditure) and insulin sensitivity based on the aging quality		120 minutes
Secondary	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)		one day
Secondary	Gene expression in muscle tissue by Global transcriptome analysis by DNA Chip		one day