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Muscle in Acromegaly and Cushing's Syndrome (MAC)

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ClinicalTrials.gov Identifier: NCT03673761
Recruitment Status : Unknown
Verified February 2019 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was:  Recruiting
First Posted : September 17, 2018
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Tracking Information
First Submitted Date August 30, 2018
First Posted Date September 17, 2018
Last Update Posted Date February 25, 2019
Actual Study Start Date February 1, 2018
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 14, 2018)
MRI assessment of fatty infiltration in tigh muscles. [ Time Frame: Within one year since recruitment ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 14, 2018)
microRNAs [ Time Frame: Within one year since recruitment ]
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Muscle in Acromegaly and Cushing's Syndrome
Official Title Role of Myosteatosis in the Occurrence and Persistence of Residual Muscle Weakness in Patients With Acromegaly and Cushing's Syndrome. Study of the Mechanisms Involved
Brief 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.
Detailed 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).
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population
  1. Patients with Sd Cushing (CS): 40 women (25-60 years) with CS, with controlled hypercortisolism after treatment and without clinical / biochemical signs of relapse for more than 5 years.
  2. Patients with acromegaly: 40 patients of both sexes (25-60 years) with GH / IGF-I controlled after treatment and without clinical / biochemical signs of relapse for more than 5 years.
  3. Controls: n = 60; normal healthy control paired by age, sex and BMI will be included.
Condition
  • Cushing Syndrome
  • Acromegaly
Intervention Other: MRI, dual-energy, x-ray absorptiometry, muscle ultrasounds, blood testing
3.Dixon, T2 mapping MRI microRNAs
Study Groups/Cohorts
  • Cushing's syndrome

    a) Patients with Sd Cushing (SC): 40 women (25-60 years) with SC, with controlled hypercortisolism after treatment and without clinical / biochemical signs of relapse for more than 5 years.

    This group will under go the following procedures:

    • muscle MRI
    • dual-energy x-ray absorptiometry
    • muscle ultrasounds
    • blood testing
    Intervention: Other: MRI, dual-energy, x-ray absorptiometry, muscle ultrasounds, blood testing
  • acromegaly

    b) Patients with acromegaly: 40 patients of both sexes (25-60 years) with GH / Insulin-like-Growth Factor (IGF-I) controlled after treatment and without clinical / biochemical signs of relapse for more than 5 years.

    This group will under go the following procedures:

    • muscle MRI
    • dual-energy x-ray absorptiometry
    • muscle ultrasounds
    • blood testing
    Intervention: Other: MRI, dual-energy, x-ray absorptiometry, muscle ultrasounds, blood testing
  • Healthy controls

    Controls: n = 40; normal healthy control paired by age, sex and BMI will be included.

    This group will under go the following procedures:

    • muscle MRI
    • dual-energy x-ray absorptiometry
    • muscle ultrasounds
    • blood testing
    Intervention: Other: MRI, dual-energy, x-ray absorptiometry, muscle ultrasounds, blood testing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 14, 2018)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 31, 2020
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03673761
Other Study ID Numbers IIBSP-MIO-2017-41
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Sponsor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators Not Provided
Investigators Not Provided
PRS Account Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Verification Date February 2019