Acromegaly Clinical Trial
— MACOfficial 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
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | Please Select |
Lead Sponsor | Collaborator |
---|---|
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Spain,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06344650 -
Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study
|
||
Active, not recruiting |
NCT02092129 -
Pituitary Histopathology and Hyperprolactinaemia and Risk of Glucose Metabolic Disturbances in Acromegaly.
|
N/A | |
Completed |
NCT02012127 -
Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
|
||
Active, not recruiting |
NCT01265121 -
Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
|
N/A | |
Terminated |
NCT00765323 -
Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly
|
Phase 3 | |
Completed |
NCT00500227 -
Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
|
||
Completed |
NCT00531908 -
Physiopathology of Sodium Retention in Acromegaly
|
N/A | |
Completed |
NCT01278342 -
Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients
|
Phase 4 | |
Active, not recruiting |
NCT01809808 -
A Prospective Study of Outcome After Therapy for Acromegaly
|
||
Completed |
NCT00145405 -
Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction
|
Phase 4 | |
Completed |
NCT00210457 -
Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients
|
Phase 3 | |
Recruiting |
NCT05401084 -
Diet in the Management of Acromegaly
|
N/A | |
Recruiting |
NCT00005100 -
Measurement of Outcome of Surgical Treatment in Patients With Acromegaly
|
N/A | |
Completed |
NCT00521300 -
Preoperative Octreotide Treatment of Acromegaly
|
Phase 4 | |
Completed |
NCT03548415 -
Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
|
Phase 2 | |
Not yet recruiting |
NCT04066569 -
Reproducibility and Utility of OGTT in Acromegaly
|
N/A | |
Not yet recruiting |
NCT05298891 -
Hypoproteic Diet in Acromegaly
|
N/A | |
Recruiting |
NCT04520646 -
A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy
|
N/A | |
Not yet recruiting |
NCT04529356 -
The TMS Treatment for Postoperative Headache in GH Tumor
|
N/A | |
Active, not recruiting |
NCT03252353 -
Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly
|
Phase 3 |