Mitochondrial Respiratory Chain DeficienciesMithycalNCT00446745
Abdominal Adiposity and Muscle Mitochondrial Functions
An observational study of Mitochondrial Respiratory Chain Deficiencies, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
Numerous studies have demonstrated that excess perivisceral adipose tissue is associated with metabolic diseases such as insulin resistance. In skeletal muscle, insulin resistance has been correlated with reduced mitochondrial oxidative functions. Read more about this study
- Who is it for?
- Ages 35 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mitochondrial Respiratory Chain Deficiencies
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2006to Jan 2007
- Phase
- Observational
- 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 35 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: * 60 Male subjects * Age between 35 and 50 * waist circumference (Waist) > 75 cm 15 men with Waist between 75 and <87cm, 15 men with Waist between 87 and <94cm, 15 men with Waist between 94 and <102cm, and 15 men with Waith equal or higher than 102cm.
Who may be able to join
- Male subjects
- Age between 35 and 50
- waist circumference > 75 cm
- Baecke score < 1 (activity score for sedentary subjects)
- Subjects giving written informed consent
- Subjects willing to comply with the study procedures
- Subjects considered as normal after clinical examination and medical questionnaire
Who cannot join
- Weight change > 3 kg within 3 months prior to study
- Patients with type 1 or type 2 diabetes
- Serologic evidence of active hepatitis B or HIV
- History of cancer or significant intestinal, hepatic, renal or cardiovascular disorders within the past 5 years
- History of systemic infections or inflammatory diseases within the past 2 months
- Hypocaloric or special diets (e.g. vegetarian)
Show all 12Show fewer
- Patients currently known to abuse or to be dependent on any drug, including alcohol (daily consumption > 20g) and tobacco (daily consumption > 5 cigarettes)
- CRP < 5 mg/L
- Blood coagulation disorders
- Allergy to xylocaïne
- for test meal : Food allergy (particularly milk allergy and lactose intolerance)
- for MRI : Claustrophobia
Trial locations and contacts
1 site in 1 country.
France1 site
Centre ed Recherche en Nutrition Humaine d'Auvergne (CRNH), Unité d'Exploration Nutritionnelle, Laboratoire de Nutrition humaine
Clermont-Ferrand, 63009 cedex 1
About this study
Official title: Study of Interaction Between Adipose and Muscle Tissues in the Control of Muscle Mitochondrial Functions
Numerous studies have demonstrated that excess perivisceral adipose tissue is associated with metabolic diseases such as insulin resistance.
In skeletal muscle, insulin resistance has been correlated with reduced mitochondrial oxidative functions. According to the actual theory, mitochondrial dysfunctions are proposed to play a causal role in the aetiology of insulin resistance. Mechanisms involve increased intramyocellular lipids storage. Yet, the causes responsible for the decline in muscle mitochondrial functions remain to be elucidated.
Read more
The investigators hypothesize that these alterations are induced by combined changes in plasma profiles of lipids and adipokines, which originate from perivisceral adipose tissue. The study aims at answering the following questions :
- Are muscle mitochondrial functions altered in association with increased perivisceral adipose tissue storage?
- Do changes in the pattern of plasma lipids and adipokines explain this correlation?
Read the detailed description
Sixty 35 to 50-years old sedentary men will be included based on their abdominal circumference (from 75 to over 102 cm).
Body composition will be evaluated using dual-energy X-ray absorptiometry and perivisceral, intramuscular and intrahepatic adiposity will be assess by MRI and proton-NMR spectroscopy. Subjects will be also characterized by their glucose tolerance (OGTT), basal metabolism (indirect calorimetry) and maximal oxygen consumption (maximal aerobic power test on exercise bike).
Blood samples will be collected in the fasted state to assess lipids and adipokines concentrations.
Biopsies will be obtained from the vastus lateralis muscle to examine mitochondrial functions (respiration rates, ATP and superoxide anion production rates, maximal activity of oxidative enzyme). Gene expression of key enzymes, protein and transcription factors involved in lipid and energy metabolism will be assessed using real-time quantitative PCR.
Finally, whole body and muscle protein metabolism will be investigated in half of the subjects using tracer infusion (incorporation of L-[1-13C]leucine) and biopsies from vastus lateralis, both in the post-absorptive and post-prandial states (test meal)
- Keywords
- Nutritional and Metabolic Diseases, Insulin resistance, Energy Metabolisms, Skeletal muscle, Visceral Adipose Tissue
- Medical subject headings
- Mitochondrial Diseases, Nutritional and Metabolic Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal obesity | 60 males were recruited according to waist circumference, from lean to obese values |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startApr 2006
- Primary completionDec 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mitochondrial Respiratory Chain DeficienciesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yves Boirie, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Investigators
- Yves Boirie, PU-PH, Principal investigator, UMR1019 INRA - Auvergne UniversityBeatrice Morio, PhD, Study director, UMR 1019 INRA - Auvergne University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446745
- Sponsor's protocol ID
- AU628
- Acronym
- Mithycal
- Status last verified
- Sep 2012
- First submitted
- 9 Mar 2007
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Chanseaume E, Tardy AL, Salles J, Giraudet C, Rousset P, Tissandier A, Boirie Y, Morio B. Chronological approach of diet-induced alterations in muscle mitochondrial functions in rats. Obesity (Silver Spring). 2007 Jan;15(1):50-9. doi: 10.1038/oby.2007.511.
PubMed 17228031Chanseaume E, Malpuech-Brugere C, Patrac V, Bielicki G, Rousset P, Couturier K, Salles J, Renou JP, Boirie Y, Morio B. Diets high in sugar, fat, and energy induce muscle type-specific adaptations in mitochondrial functions in rats. J Nutr. 2006 Aug;136(8):2194-200. doi: 10.1093/jn/136.8.2194.
PubMed 16857840Chanseaume E, Barquissau V, Salles J, Aucouturier J, Patrac V, Giraudet C, Gryson C, Duche P, Boirie Y, Chardigny JM, Morio B. Muscle mitochondrial oxidative phosphorylation activity, but not content, is altered with abdominal obesity in sedentary men: synergism with changes in insulin sensitivity. J Clin Endocrinol Metab. 2010 Jun;95(6):2948-56. doi: 10.1210/jc.2009-1938. Epub 2010 Apr 9.
PubMed 20382691
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Interaction Between Adipose and Muscle Tissues in the Control of Muscle Mitochondrial Functions
- ClinicalTrials.gov ID
- NCT00446745
- Acronym / sponsor ID
- Mithycal / AU628
- Keywords
- Nutritional and Metabolic Diseases, Insulin resistance, Energy Metabolisms, Skeletal muscle, Visceral Adipose Tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 13 Mar 2007 (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.
Numerous studies have demonstrated that excess perivisceral adipose tissue is associated with metabolic diseases such as insulin resistance.
In skeletal muscle, insulin resistance has been correlated with reduced mitochondrial oxidative functions. According to the actual theory, mitochondrial dysfunctions are proposed to play a causal role in the aetiology of insulin resistance. Mechanisms involve increased intramyocellular lipids storage. Yet, the causes responsible for the decline in muscle mitochondrial functions remain to be elucidated.
The investigators hypothesize that these alterations are induced by combined changes in plasma profiles of lipids and adipokines, which originate from perivisceral adipose tissue. The study aims at answering the following questions :
- Are muscle mitochondrial functions altered in association with increased perivisceral adipose tissue storage?
- Do changes in the pattern of plasma lipids and adipokines explain this correlation?
Detailed description
Sixty 35 to 50-years old sedentary men will be included based on their abdominal circumference (from 75 to over 102 cm).
Body composition will be evaluated using dual-energy X-ray absorptiometry and perivisceral, intramuscular and intrahepatic adiposity will be assess by MRI and proton-NMR spectroscopy. Subjects will be also characterized by their glucose tolerance (OGTT), basal metabolism (indirect calorimetry) and maximal oxygen consumption (maximal aerobic power test on exercise bike).
Blood samples will be collected in the fasted state to assess lipids and adipokines concentrations.
Biopsies will be obtained from the vastus lateralis muscle to examine mitochondrial functions (respiration rates, ATP and superoxide anion production rates, maximal activity of oxidative enzyme). Gene expression of key enzymes, protein and transcription factors involved in lipid and energy metabolism will be assessed using real-time quantitative PCR.
Finally, whole body and muscle protein metabolism will be investigated in half of the subjects using tracer infusion (incorporation of L-[1-13C]leucine) and biopsies from vastus lateralis, both in the post-absorptive and post-prandial states (test meal)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal obesity | – | –60 males were recruited according to waist circumference, from lean to obese values |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * 60 Male subjects * Age between 35 and 50 * waist circumference (Waist) > 75 cm 15 men with Waist between 75 and <87cm, 15 men with Waist between 87 and <94cm, 15 men with Waist between 94 and <102cm, and 15 men with Waith equal or higher than 102cm.
Key inclusion criteria (7 listed)
- Male subjects
- Age between 35 and 50
- waist circumference > 75 cm
- Baecke score < 1 (activity score for sedentary subjects)
- Subjects giving written informed consent
Key exclusion criteria (12 listed)
- Weight change > 3 kg within 3 months prior to study
- Patients with type 1 or type 2 diabetes
- Serologic evidence of active hepatitis B or HIV
- History of cancer or significant intestinal, hepatic, renal or cardiovascular disorders within the past 5 years
- History of systemic infections or inflammatory diseases within the past 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 19 Sep 2012.
- Background: PubMed 17228031Chanseaume E, Tardy AL, Salles J, Giraudet C, Rousset P, Tissandier A, Boirie Y, Morio B. Chronological approach of diet-induced alterations in muscle mitochondrial functions in rats. Obesity (Silver Spring). 2007 Jan;15(1):50-9. doi: 10.1038/oby.2007.511.
- Background: PubMed 16857840Chanseaume E, Malpuech-Brugere C, Patrac V, Bielicki G, Rousset P, Couturier K, Salles J, Renou JP, Boirie Y, Morio B. Diets high in sugar, fat, and energy induce muscle type-specific adaptations in mitochondrial functions in rats. J Nutr. 2006 Aug;136(8):2194-200. doi: 10.1093/jn/136.8.2194.
- Derived from this study: PubMed 20382691Chanseaume E, Barquissau V, Salles J, Aucouturier J, Patrac V, Giraudet C, Gryson C, Duche P, Boirie Y, Chardigny JM, Morio B. Muscle mitochondrial oxidative phosphorylation activity, but not content, is altered with abdominal obesity in sedentary men: synergism with changes in insulin sensitivity. J Clin Endocrinol Metab. 2010 Jun;95(6):2948-56. doi: 10.1210/jc.2009-1938. Epub 2010 Apr 9.
- ANR consortium websiteLink provided by the sponsor.
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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.
Yves Boirie, PU-PH principal investigator
UMR1019 INRA - Auvergne University
Beatrice Morio, PhD study director
UMR 1019 INRA - Auvergne University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitochondrial Respiratory Chain Deficiencies, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement 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 7 inclusion and 12 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 19 Sep 2012. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00446745, which also lists 3 linked publications.
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 19 Sep 2012.