Insulin SensitivityCOMPALICLAMPNCT00951392
Implication of Metabolic and Genomic Modifications in Elderly Subjects
A study testing euglycemic hyperinsulinemic clamp, muscle biopsy and indirect calorimetry in people with Insulin Sensitivity and Aging, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Aging
- What is being tested?
- euglycemic hyperinsulinemic clamp, muscle biopsy and indirect calorimetry
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- May 2009to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
France1 site
Centre de recherche en nutrition humaine Rhône-Alpes
Pierre-Bénite, 69495
About this study
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.
- Conditions
- Insulin Sensitivity, Aging
- Being tested
- euglycemic hyperinsulinemic clamp, muscle biopsy, indirect calorimetry
- Keywords
- Insulin sensitivity, aging, lipid metabolism, hyperinsulinemic clamp, gene expression, sirtuins
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
euglycemic hyperinsulinemic clampDrug
Insulin perfusion at 1 mU.kg-1.min-1
Glucose perfusion to maintain euglycemia at 5,0 ± 0,5 mmol/l
Blood tests
muscle biopsyProcedure or surgery
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 calorimetryDevice
energy expenditure measurement
| Study group | Role | What they receive |
|---|---|---|
| Problematic aging | Experimental | Not described Receives: Drug: euglycemic hyperinsulinemic clamp; Procedure: muscle biopsy; Device: indirect calorimetry |
| successful aging | Experimental | Not described Receives: Drug: euglycemic hyperinsulinemic clamp; Procedure: muscle biopsy; Device: indirect calorimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of metabolic profile (lipid metabolism and energy expenditure) and insulin sensitivity based on the aging quality
Measured: 120 minutes
Secondary outcomes (2)
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)
Measured: one day
Gene expression in muscle tissue by Global transcriptome analysis by DNA Chip
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Martine LAVILLE, MD, PhD, Principal investigator, Centre de Recherche en Nutrition Humaine Rhone-Alpe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951392
- Sponsor's protocol ID
- 2008.547
- Acronym
- COMPALICLAMP
- Status last verified
- Mar 2010
- First submitted
- 31 Jul 2009
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29657112
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implication of Metabolic and Genomic Modifications in Elderly Subjects
- ClinicalTrials.gov ID
- NCT00951392
- Acronym / sponsor ID
- COMPALICLAMP / 2008.547
- Conditions
- Insulin Sensitivity, Aging
- Keywords
- Insulin sensitivity, aging, lipid metabolism, hyperinsulinemic clamp, gene expression, sirtuins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Problematic aging | Experimental | Drug: euglycemic hyperinsulinemic clamp, Procedure: muscle biopsy, Device: indirect calorimetry |
| successful aging | Experimental | Drug: euglycemic hyperinsulinemic clamp, Procedure: muscle biopsy, Device: indirect calorimetry |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| euglycemic hyperinsulinemic clampInsulin perfusion at 1 mU.kg-1.min-1 Glucose perfusion to maintain euglycemia at 5,0 ± 0,5 mmol/l Blood tests | Drug | Problematic aging, successful aging |
| muscle biopsyGene 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 | Procedure or surgery | Problematic aging, successful aging |
| indirect calorimetryenergy expenditure measurement | Device | Problematic aging, successful aging |
Primary outcome
Comparison of metabolic profile (lipid metabolism and energy expenditure) and insulin sensitivity based on the aging quality
Time frame: 120 minutes
2 secondary outcomes
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
Gene expression in muscle tissue by Global transcriptome analysis by DNA Chip
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Results publication: PubMed 29657112Betry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine LAVILLE, MD, PhD principal investigator
Centre de Recherche en Nutrition Humaine Rhone-Alpe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing euglycemic hyperinsulinemic clamp, muscle biopsy and indirect calorimetry in people with Insulin Sensitivity and Aging, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of metabolic profile (lipid metabolism and energy expenditure) and insulin sensitivity based on the aging quality (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00951392, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.