Charcot-Marie-Tooth DiseaseIRICDENCT04786522
Irisin Levels in Patients With Charcot-Marie-Tooth (CMT) Disease
An observational study of Charcot-Marie-Tooth Disease, run by University of Bari at 1 site in Italy.
Trial summary
Irisin is an exercise-mimetic myokine secreted by skeletal muscle. Compelling evidence in animal models and humans showed that Irisin prevents onset of musculoskeletal atrophy and its low serum levels are predictive of sarcopenia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Charcot-Marie-Tooth Disease
- What is being tested?
- Bioimpedenziometry, Handgrip strenght evaluation and Evaluation on blood specimens
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 2 Nov 2019to 30 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with Charcot-Marie-Tooth disease who have given informed consent
Who may be able to join
- Definitive diagnosis of Charcot-Marie-Tooth disease
Who cannot join
- osteoporosis
- intestinal malabsorption
- chronic inflammatory diseases
- chronic renal failure
- severe heart failure
- neoplastic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Irisin on Muscle Quality in a Cohort of Charcot-Marie-Tooth Patients
Irisin is an exercise-mimetic myokine secreted by skeletal muscle. Compelling evidence in animal models and humans showed that Irisin prevents onset of musculoskeletal atrophy and its low serum levels are predictive of sarcopenia. The investigators evaluated the levels of irisin in patients affected by an hereditary motor and sensory neuropathy, namely Charcot-Marie-Tooth disease (CMT), in order to investigate possible key determinants of their muscle quality and possibly prevent the progressive distal weakness and muscle atrophy.
Read the detailed description
Currently, there are no effective treatment approaches for CMT other than treating symptoms with medications such as nonsteroidal anti-inflammatory drugs that provide relief of lower back or leg pain. Except for the most severe cases in which orthopedic surgery is recommended to correct pes cavus and/or spine deformities, rehabilitative management of patients with CMT has shown that physical activity can provide a moderate increase in muscle strength and musculoskeletal function, improving activities of daily living. Benefits of exercise on the musculoskeletal system are widely recognized as primary non-pharmacologic intervention for several diseases. The positive outcome of physical activity is achieved not only by the mechanical load applied on the musculoskeletal system, but also via biochemical signals, the myokines, secreted during contraction that act locally or systemically on several body districts. Among these, Irisin is a hormone-peptide synthesized from skeletal muscle performing key actions on the whole-body metabolism. In humans, the investigators have documented with several studies an existing positive association between circulating levels of Irisin and bone mineral density. Very recently, in muscle biopsies of older adult subjects, the investigators also observed that the expression of the Irisin precursor, the fibronectin type III domain-containing protein 5 (FNDC5), was positively associated with Irisin serum levels and osteocalcin mRNA expression in bone biopsies, indicating a strong correlation between healthy muscle and bone tissues. In humans, low levels of circulating Irisin have been found to be predictive of muscle weakness and atrophy, and Irisin has been identified as a sensitive molecular biomarker for sarcopenia in postmenopausal women. In addition, women older than 65 years undergoing a 12-week exercise program showed an increase in circulating Irisin and an improvement in isokinetic leg strength and grip strength compared with control women. Moreover, there was a positive correlation between Irisin levels with grip strength and leg strength in the exercise group, suggesting a causal relationship between improved muscle strength and increased Irisin concentration. Although numerous reports recommend increasing muscle strength in CMT patients to prevent progressive distal weakness and muscle atrophy, few studies have investigated the possible key determinants of muscle quality in these patients. Therefore, the aim of this study was to evaluate circulating Irisin levels in a population of 20 CMT patients as well the association of Irisin with biochemical parameters and muscle quality. In addition, the investigators compared these data with unpublished data previously obtained in healthy subjects.
- Conditions
- Charcot-Marie-Tooth Disease
- Being tested
- Bioimpedenziometry, Handgrip strenght evaluation, Evaluation on blood specimens
- Keywords
- bioimpedance analysis, handgrip strength, body composition
- Medical subject headings
- Charcot-Marie-Tooth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioimpedenziometry, Handgrip strenght evaluationDiagnostic test
The measurement of body composition was performed using Bioimpedance (BIA 101, Akern srl, Pontassieve (FI), Italy). The handgrip dynamometer (Jamar, Sammons Preston, Bolingbrook, IL, USA) was used to determine the isometric force of the forearm.
Evaluation on blood specimensDiagnostic test
Serum samples were assayed for calcium, phosphorus, magnesium, iron, lactate dehydrogenase (Ldh), creatine phosphokinase (Cpk), creatine kinase myocardial band (Ckmmb), myoglobin, thyroid stimulating hormone (TSH), 25(OH)-Vitamin D, osteocalcin, bone alkaline phosphatase (b-ALP), C-terminal telopeptide of type I collagen (CTX-I), haptoglobin, sclerostin, myostatin, and Irisin. Irisin serum concentrations were detected using a competitive ELISA kit (AdipoGen, Liestal, Switzerland)
What is being measured
The primary outcome is the main question the study is designed to answer.
Irisin level assessment
Irisin levels in the blood at enrollment
Measured: At enrollment
muscle mass assessment
Muscle mass determined by bioelectrical impedance analysis
Measured: At enrollment
muscle strenght assessment
Muscle strenght by handgrip dynamometer
Measured: At enrollment
muscle quality assessment
Muscle quality determined by bioelectrical impedance analysis
Measured: At enrollment
Correlation between irisin levels and muscle mass, muscle strenght, and muscle quality
Correlation determined by Pearson's correlation for linear regression analysis
Measured: Immediately after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start2 Nov 2019
- Primary completion31 Oct 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Charcot-Marie-Tooth DiseaseStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Barone, University of Bari
- Investigators
- Michele Barone, prof., Principal investigator, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786522
- Sponsor's protocol ID
- Iri-mCMT
- Acronym
- IRICDE
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grandis M, Shy ME. Current Therapy for Charcot-Marie-Tooth Disease. Curr Treat Options Neurol. 2005 Jan;7(1):23-31. doi: 10.1007/s11940-005-0003-5.
PubMed 15610704Mann DC, Hsu JD. Triple arthrodesis in the treatment of fixed cavovarus deformity in adolescent patients with Charcot-Marie-Tooth disease. Foot Ankle. 1992 Jan;13(1):1-6. doi: 10.1177/107110079201300101.
PubMed 1577335Guyton GP, Mann RA. The pathogenesis and surgical management of foot deformity in Charcot-Marie-Tooth disease. Foot Ankle Clin. 2000 Jun;5(2):317-26.
PubMed 11232233Corrado B, Ciardi G, Bargigli C. Rehabilitation Management of the Charcot-Marie-Tooth Syndrome: A Systematic Review of the Literature. Medicine (Baltimore). 2016 Apr;95(17):e3278. doi: 10.1097/MD.0000000000003278.
PubMed 27124017Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
PubMed 21694556Ma J, Chen K. The role of Irisin in multiorgan protection. Mol Biol Rep. 2021 Jan;48(1):763-772. doi: 10.1007/s11033-020-06067-1. Epub 2021 Jan 3.
PubMed 33389537Maak S, Norheim F, Drevon CA, Erickson HP. Progress and Challenges in the Biology of FNDC5 and Irisin. Endocr Rev. 2021 Jul 16;42(4):436-456. doi: 10.1210/endrev/bnab003.
PubMed 33493316Colaianni G, Storlino G, Sanesi L, Colucci S, Grano M. Myokines and Osteokines in the Pathogenesis of Muscle and Bone Diseases. Curr Osteoporos Rep. 2020 Aug;18(4):401-407. doi: 10.1007/s11914-020-00600-8.
PubMed 32514668Colaianni G, Notarnicola A, Sanesi L, Brunetti G, Lippo L, Celi M, Moretti L, Pesce V, Vicenti G, Moretti B, Colucci S, Grano M. Irisin levels correlate with bone mineral density in soccer players. J Biol Regul Homeost Agents. 2017 Oct-Dec,;31(4 suppl 1):21-28.
PubMed 29181953Colaianni G, Faienza MF, Sanesi L, Brunetti G, Pignataro P, Lippo L, Bortolotti S, Storlino G, Piacente L, D'Amato G, Colucci S, Grano M. Irisin serum levels are positively correlated with bone mineral status in a population of healthy children. Pediatr Res. 2019 Mar;85(4):484-488. doi: 10.1038/s41390-019-0278-y. Epub 2019 Jan 15.
PubMed 30683930Faienza MF, Brunetti G, Sanesi L, Colaianni G, Celi M, Piacente L, D'Amato G, Schipani E, Colucci S, Grano M. High irisin levels are associated with better glycemic control and bone health in children with Type 1 diabetes. Diabetes Res Clin Pract. 2018 Jul;141:10-17. doi: 10.1016/j.diabres.2018.03.046. Epub 2018 Apr 19.
PubMed 29679630Palermo A, Sanesi L, Colaianni G, Tabacco G, Naciu AM, Cesareo R, Pedone C, Lelli D, Brunetti G, Mori G, Colucci S, Manfrini S, Napoli N, Grano M. A Novel Interplay Between Irisin and PTH: From Basic Studies to Clinical Evidence in Hyperparathyroidism. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3088-3096. doi: 10.1210/jc.2018-02216.
PubMed 30759249Colaianni G, Errede M, Sanesi L, Notarnicola A, Celi M, Zerlotin R, Storlino G, Pignataro P, Oranger A, Pesce V, Tarantino U, Moretti B, Grano M. Irisin Correlates Positively With BMD in a Cohort of Older Adult Patients and Downregulates the Senescent Marker p21 in Osteoblasts. J Bone Miner Res. 2021 Feb;36(2):305-314. doi: 10.1002/jbmr.4192. Epub 2020 Oct 29.
PubMed 33053231Chang JS, Kim TH, Nguyen TT, Park KS, Kim N, Kong ID. Circulating irisin levels as a predictive biomarker for sarcopenia: A cross-sectional community-based study. Geriatr Gerontol Int. 2017 Nov;17(11):2266-2273. doi: 10.1111/ggi.13030. Epub 2017 Apr 10.
PubMed 28394089Budziareck MB, Pureza Duarte RR, Barbosa-Silva MC. Reference values and determinants for handgrip strength in healthy subjects. Clin Nutr. 2008 Jun;27(3):357-62. doi: 10.1016/j.clnu.2008.03.008. Epub 2008 May 2.
PubMed 18455840
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Irisin on Muscle Quality in a Cohort of Charcot-Marie-Tooth Patients
- ClinicalTrials.gov ID
- NCT04786522
- Acronym / sponsor ID
- IRICDE / Iri-mCMT
- Conditions
- Charcot-Marie-Tooth Disease
- Keywords
- bioimpedance analysis, handgrip strength, body composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 2 Nov 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 8 Mar 2021 (actual)
- 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.
Irisin is an exercise-mimetic myokine secreted by skeletal muscle. Compelling evidence in animal models and humans showed that Irisin prevents onset of musculoskeletal atrophy and its low serum levels are predictive of sarcopenia. The investigators evaluated the levels of irisin in patients affected by an hereditary motor and sensory neuropathy, namely Charcot-Marie-Tooth disease (CMT), in order to investigate possible key determinants of their muscle quality and possibly prevent the progressive distal weakness and muscle atrophy.
Detailed description
Currently, there are no effective treatment approaches for CMT other than treating symptoms with medications such as nonsteroidal anti-inflammatory drugs that provide relief of lower back or leg pain. Except for the most severe cases in which orthopedic surgery is recommended to correct pes cavus and/or spine deformities, rehabilitative management of patients with CMT has shown that physical activity can provide a moderate increase in muscle strength and musculoskeletal function, improving activities of daily living. Benefits of exercise on the musculoskeletal system are widely recognized as primary non-pharmacologic intervention for several diseases. The positive outcome of physical activity is achieved not only by the mechanical load applied on the musculoskeletal system, but also via biochemical signals, the myokines, secreted during contraction that act locally or systemically on several body districts. Among these, Irisin is a hormone-peptide synthesized from skeletal muscle performing key actions on the whole-body metabolism. In humans, the investigators have documented with several studies an existing positive association between circulating levels of Irisin and bone mineral density. Very recently, in muscle biopsies of older adult subjects, the investigators also observed that the expression of the Irisin precursor, the fibronectin type III domain-containing protein 5 (FNDC5), was positively associated with Irisin serum levels and osteocalcin mRNA expression in bone biopsies, indicating a strong correlation between healthy muscle and bone tissues. In humans, low levels of circulating Irisin have been found to be predictive of muscle weakness and atrophy, and Irisin has been identified as a sensitive molecular biomarker for sarcopenia in postmenopausal women. In addition, women older than 65 years undergoing a 12-week exercise program showed an increase in circulating Irisin and an improvement in isokinetic leg strength and grip strength compared with control women. Moreover, there was a positive correlation between Irisin levels with grip strength and leg strength in the exercise group, suggesting a causal relationship between improved muscle strength and increased Irisin concentration. Although numerous reports recommend increasing muscle strength in CMT patients to prevent progressive distal weakness and muscle atrophy, few studies have investigated the possible key determinants of muscle quality in these patients. Therefore, the aim of this study was to evaluate circulating Irisin levels in a population of 20 CMT patients as well the association of Irisin with biochemical parameters and muscle quality. In addition, the investigators compared these data with unpublished data previously obtained in healthy subjects.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with Charcot-Marie-Tooth disease who have given informed consent
Key inclusion criteria (1 listed)
- Definitive diagnosis of Charcot-Marie-Tooth disease
Key exclusion criteria (6 listed)
- osteoporosis
- intestinal malabsorption
- chronic inflammatory diseases
- chronic renal failure
- severe heart failure
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 |
|---|---|---|
| Bioimpedenziometry, Handgrip strenght evaluationThe measurement of body composition was performed using Bioimpedance (BIA 101, Akern srl, Pontassieve (FI), Italy). The handgrip dynamometer (Jamar, Sammons Preston, Bolingbrook, IL, USA) was used to determine the isometric force of the forearm. | Diagnostic test | – |
| Evaluation on blood specimensSerum samples were assayed for calcium, phosphorus, magnesium, iron, lactate dehydrogenase (Ldh), creatine phosphokinase (Cpk), creatine kinase myocardial band (Ckmmb), myoglobin, thyroid stimulating hormone (TSH), 25(OH)-Vitamin D, osteocalcin, bone alkaline phosphatase (b-ALP), C-terminal telopeptide of type I collagen (CTX-I), haptoglobin, sclerostin, myostatin, and Irisin. Irisin serum concentrations were detected using a competitive ELISA kit (AdipoGen, Liestal, Switzerland) | Diagnostic test | – |
Primary outcome
Irisin level assessment
Time frame: At enrollment
Irisin levels in the blood at enrollment
muscle mass assessment
Time frame: At enrollment
Muscle mass determined by bioelectrical impedance analysis
muscle strenght assessment
Time frame: At enrollment
Muscle strenght by handgrip dynamometer
muscle quality assessment
Time frame: At enrollment
Muscle quality determined by bioelectrical impedance analysis
Correlation between irisin levels and muscle mass, muscle strenght, and muscle quality
Time frame: Immediately after enrollment
Correlation determined by Pearson's correlation for linear regression analysis
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 10 Mar 2021.
- Results publication: PubMed 15610704Grandis M, Shy ME. Current Therapy for Charcot-Marie-Tooth Disease. Curr Treat Options Neurol. 2005 Jan;7(1):23-31. doi: 10.1007/s11940-005-0003-5.
- Results publication: PubMed 1577335Mann DC, Hsu JD. Triple arthrodesis in the treatment of fixed cavovarus deformity in adolescent patients with Charcot-Marie-Tooth disease. Foot Ankle. 1992 Jan;13(1):1-6. doi: 10.1177/107110079201300101.
- Results publication: PubMed 11232233Guyton GP, Mann RA. The pathogenesis and surgical management of foot deformity in Charcot-Marie-Tooth disease. Foot Ankle Clin. 2000 Jun;5(2):317-26.
- Results publication: PubMed 27124017Corrado B, Ciardi G, Bargigli C. Rehabilitation Management of the Charcot-Marie-Tooth Syndrome: A Systematic Review of the Literature. Medicine (Baltimore). 2016 Apr;95(17):e3278. doi: 10.1097/MD.0000000000003278.
- Results publication: PubMed 21694556Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
- Results publication: PubMed 33389537Ma J, Chen K. The role of Irisin in multiorgan protection. Mol Biol Rep. 2021 Jan;48(1):763-772. doi: 10.1007/s11033-020-06067-1. Epub 2021 Jan 3.
- Results publication: PubMed 33493316Maak S, Norheim F, Drevon CA, Erickson HP. Progress and Challenges in the Biology of FNDC5 and Irisin. Endocr Rev. 2021 Jul 16;42(4):436-456. doi: 10.1210/endrev/bnab003.
- Results publication: PubMed 32514668Colaianni G, Storlino G, Sanesi L, Colucci S, Grano M. Myokines and Osteokines in the Pathogenesis of Muscle and Bone Diseases. Curr Osteoporos Rep. 2020 Aug;18(4):401-407. doi: 10.1007/s11914-020-00600-8.
- Results publication: PubMed 29181953Colaianni G, Notarnicola A, Sanesi L, Brunetti G, Lippo L, Celi M, Moretti L, Pesce V, Vicenti G, Moretti B, Colucci S, Grano M. Irisin levels correlate with bone mineral density in soccer players. J Biol Regul Homeost Agents. 2017 Oct-Dec,;31(4 suppl 1):21-28.
- Results publication: PubMed 30683930Colaianni G, Faienza MF, Sanesi L, Brunetti G, Pignataro P, Lippo L, Bortolotti S, Storlino G, Piacente L, D'Amato G, Colucci S, Grano M. Irisin serum levels are positively correlated with bone mineral status in a population of healthy children. Pediatr Res. 2019 Mar;85(4):484-488. doi: 10.1038/s41390-019-0278-y. Epub 2019 Jan 15.
- Results publication: PubMed 29679630Faienza MF, Brunetti G, Sanesi L, Colaianni G, Celi M, Piacente L, D'Amato G, Schipani E, Colucci S, Grano M. High irisin levels are associated with better glycemic control and bone health in children with Type 1 diabetes. Diabetes Res Clin Pract. 2018 Jul;141:10-17. doi: 10.1016/j.diabres.2018.03.046. Epub 2018 Apr 19.
- Results publication: PubMed 30759249Palermo A, Sanesi L, Colaianni G, Tabacco G, Naciu AM, Cesareo R, Pedone C, Lelli D, Brunetti G, Mori G, Colucci S, Manfrini S, Napoli N, Grano M. A Novel Interplay Between Irisin and PTH: From Basic Studies to Clinical Evidence in Hyperparathyroidism. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3088-3096. doi: 10.1210/jc.2018-02216.
- Individual participant dataSharing planned: No
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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.
Michele Barone, prof. principal investigator
University of Bari
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 Charcot-Marie-Tooth Disease, run by University of Bari at 1 site in Italy.
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 1 inclusion and 6 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 10 Mar 2021. 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 Italy. 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?
Irisin level assessment (time frame: At enrollment). The study lists 5 primary outcomes in all. 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 NCT04786522, which also lists 17 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 10 Mar 2021.