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
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Condition or disease | Intervention/treatment |
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Cushing Syndrome Acromegaly | Other: MRI, dual-energy, x-ray absorptiometry, muscle ultrasounds, blood testing |
Study Type : | Observational |
Estimated Enrollment : | 120 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
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 |
Actual Study Start Date : | February 1, 2018 |
Estimated Primary Completion Date : | October 31, 2019 |
Estimated Study Completion Date : | January 31, 2020 |

Group/Cohort | Intervention/treatment |
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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:
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Other: MRI, dual-energy, x-ray absorptiometry, muscle ultrasounds, blood testing
3.Dixon, T2 mapping MRI microRNAs |
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:
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Other: MRI, dual-energy, x-ray absorptiometry, muscle ultrasounds, blood testing
3.Dixon, T2 mapping MRI microRNAs |
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:
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Other: MRI, dual-energy, x-ray absorptiometry, muscle ultrasounds, blood testing
3.Dixon, T2 mapping MRI microRNAs |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
- 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.
- 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.
- Controls: n = 60; normal healthy control paired by age, sex and BMI will be included.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673761
Contact: Elena Valassi, MD, PhD | +34932919000 ext 1942 | EValassi@santpau.cat |
Spain | |
Hospital de la Santa Creu i Sant Pau | Recruiting |
Barcelona, Please Select, Spain, 08025 | |
Contact: Elena Valassi, MD, PhD +349329190000 ext 1942 EValassi@santpau.cat |
Responsible Party: | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
ClinicalTrials.gov Identifier: | NCT03673761 |
Other Study ID Numbers: |
IIBSP-MIO-2017-41 |
First Posted: | September 17, 2018 Key Record Dates |
Last Update Posted: | February 25, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
muscle weakness myopathy |
Acromegaly Muscle Weakness Cushing Syndrome Syndrome Disease Pathologic Processes Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases |
Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Muscular Diseases Neuromuscular Manifestations Neurologic Manifestations Adrenocortical Hyperfunction Adrenal Gland Diseases |