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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03673761
Other study ID # IIBSP-MIO-2017-41
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2018
Est. completion date January 31, 2020

Study information

Verified date February 2019
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact Elena Valassi, MD, PhD
Phone +34932919000
Email EValassi@santpau.cat
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cushing's syndrome (CS) and acromegaly determine myopathy and muscle weakness which persist long-term after control of hormone excess. Fatty infiltration in skeletal muscle (myosteatosis) is associated with muscle atrophy, frailty, and increased morbidity and mortality in several human models. The study is aimed at evaluating muscle structure in patients with controlled CS and acromegaly, and correlate it with functional tests of muscle strength. In addition, circulating molecules potentially mediating persistent myopathy in these patients will also be assessed.


Description:

Prior chronic exposure to glucocorticoids or growth hormone (GH) determines fat infiltration and persistent impairment of muscle structure in "cured" patients with CS or acromegaly, respectively. All this leads to irreversible changes in muscle strength and performance, markedly affecting morbidity and quality of life of these patients. In particular, muscle weakness would contribute significantly to the development of severe arthropathy associated with excess GH, as well as deterioration of bone status and increased risk of fracture, as described in patients with either CS or acromegaly in remission. Our aim is to evaluate whether muscular MRI is a useful tool for the assessment of myopathy and myosteatosis in these patients. If this is the case, we would have identified a non-invasive test that would allow the follow-up of patients at risk of developing functional motor problems, anticipating the onset of muscle weakness or fatigue and consequent deterioration of their quality of life. On the other hand, we will examine the role of microRNAs, which can suppress the process of myogenic differentiation, as potential modulators of myopathy in these conditions. Indeed, microRNAs could be used in clinical practice as markers to identify patients at risk of myopathy, and develop strategies for their prevention. Clarifying the impact of muscle fat infiltration on muscle strength would allow us to better understand the interaction between muscle and adipose tissue, encouraging research on potential mediators of this relationship, such as myostatin (MSTN) (able to direct the mesenchymal cell muscle towards the formation of adipocytes at the expense of myocytes) and adiponectin (ApN) (which keeps the levels of fat in the muscle low while favoring the formation and regeneration of muscle tissue).


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date January 31, 2020
Est. primary completion date October 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients with Cushing's syndrome or acromegaly who have been in remission for at least 5 years.

Exclusion Criteria:

- Pregnancy, breastfeeding, chronic liver/kidney disease, chronic treatment with glucocorticoids.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
MRI, dual-energy, x-ray absorptiometry, muscle ultrasounds, blood testing
3.Dixon, T2 mapping MRI microRNAs

Locations

Country Name City State
Spain Hospital de la Santa Creu i Sant Pau Barcelona Please Select

Sponsors (1)

Lead Sponsor Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary MRI assessment of fatty infiltration in tigh muscles. Quantitative muscle 3Tesla-MRI (mappting T2 and 3.Dixon) will be used. Assessment of fatty infiltration as well as measurement of necrosis and inflammation areas in tigh muscles will be performed. Within one year since recruitment
Secondary microRNAs A bioinformatic study will be carried out to select a set of miRNAs differentially expressed in acromegaly and Cushing's syndrome as compared with controls. The miRNAs will be selected according to the pathophysiological pathways (GO, KEGG) in which they are involved and taking into account the pathophysiology of Cushing's syndrome and acromegaly. Differentially expressed miRNAs will be then related to primary outcome measures. Within one year since recruitment
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