Implication of Metabolic and Genomic Modifications in Elderly Subjects (COMPALICLAMP)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Insulin Sensitivity Aging |
Drug: euglycemic hyperinsulinemic clamp Procedure: muscle biopsy Device: indirect calorimetry |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Implication of Metabolic and Genomic Modifications in Elderly Subjects |
- Comparison of metabolic profile (lipid metabolism and energy expenditure) and insulin sensitivity based on the aging quality [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Gene expression in muscle tissue by Global transcriptome analysis by DNA Chip [ Time Frame: one day ] [ Designated as safety issue: No ]
| Enrollment: | 35 |
| Study Start Date: | May 2009 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Problematic aging |
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 Gene expression in muscle tissue will be studied with two approaches :
energy expenditure measurement
|
| Experimental: successful aging |
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 Gene expression in muscle tissue will be studied with two approaches :
energy expenditure measurement
|
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations| France | |
| Centre de recherche en nutrition humaine Rhône-Alpes | |
| Pierre-Bénite, France, 69495 | |
| Principal Investigator: | Martine LAVILLE, MD, PhD | Centre de recherche en nutrition humaine Rhône-Alpes |
More Information
No publications provided
| Responsible Party: | Martine Laville PhD, MD, Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT00951392 History of Changes |
| Other Study ID Numbers: | 2008.547 |
| Study First Received: | July 31, 2009 |
| Last Updated: | March 8, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Hospices Civils de Lyon:
|
Insulin sensitivity aging lipid metabolism |
hyperinsulinemic clamp gene expression sirtuins |
Additional relevant MeSH terms:
|
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013