Clinical Trial: Alterations in Muscle's Functional Characteristics After Parathyroid Surgery for Primary Hyperparathyroidism.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Alterations in Muscle's Functional Characteristics After Parathyroid Surgery for Primary Hyperparathyroidism.

Brief Summary:

Protocol title: Alterations in functional characteristics of the muscle tissue following surgery for primary hyperparathyroidism.

Purpose: To detect any changes in functional characteristics of muscles in patients who undergo surgery for primary hyperparathyroidism compared to patients with primary hyperparathyroidism and conservative treatment, patients undergoing thyroid surgery and healthy subjects.

Design: Prospective, multi-center observational study Patient Population: Male or female subjects 18 years of age or older scheduled for parathyroidectomy No. of Subjects: 50 patients undergoing parathyroidectomy, 50 patients undergoing conservative follow up, 50 patients undergoing thyroid surgery due to nontoxic multinodular goiter or solitary nontoxic thyroid adenoma and 50 healthy control subjects, estimated up to 12 months to enroll.

Duration of Treatment: During the operation Duration of Follow-up: Follow-up will be performed daily during hospitalization and at 3, 6 and 12 months after the procedure Endpoints: To evaluate the changes in functional characteristics of all the type of muscles which occur after parathyroidectomy for primary hyperparathyroidism.

Detailed Summary:

1.0 INTRODUCTION The association between parathyroidectomy and cardiovascular status improvement is still inconclusive. There is evidence to suggest that primary hyperparathyroidism (PHPT) is associated with hypertension, whereas few studies show that hypertension does not reverse after surgical care. Moreover, left ventricular hypertrophy (LVH) is considered to be linearly associated with parathyroid hormone (PTH) and independent of hypertension. In addition, inflammatory changes in the cardiovascular system, which are expected to occur after parathyroidectomy, can be evaluated by assessing the levels of inflammation biomarkers, such as high-sensitivity C reactive protein (hs-CRP), increased levels of which are associated with high cardiovascular event rate. The investigators will evaluate cardiovascular system before and after parathyroidectomy by appraising the levels of hs-CRP, measuring Left Ventricular Mass Index (LVMI) and monitoring patients' blood pressure (BP) for 24 hours.

Primary hyperparathyroidism (PHPT) has also been associated with neuromuscular abnormalities. The typical symptoms are proximal muscle weakness and muscle atrophy, especially of type II fibers. Other symptoms are generalized fatigue, reduced well-being, hyperreflexia, abnormal gait and tongue fasciculations. Although, nowadays, most of the symptoms with which patients are presented are mild or completely absent probably because PHPT is detected at a preclinical stage. On the other hand, many "asymptomatic" patients preoperatively, report subjective amelioration after the surgery, with respect to muscle strength and function. The investigators will conduct clinical examination, focusing on neuromuscular status, assess motor nerve conduction velocity, using electroneurography (ENG) and muscle strength, using isokinetic dynamometers. Moreover, the investigators will evaluate neuromuscu
Sponsor: Aristotle University Of Thessaloniki

Current Primary Outcome:

• Measuring stapedius reflex. [ Time Frame: It will be assessed before surgery and at 3, 6 and 12 months after parathyroidectomy ]
  Due to the fact that stapedius muscle is the smallest skeletal muscle in the human body, the investigators tend to measure stapedius reflex in order to test the hypothesis that there is association between acoustic reflex improvement and parathyroidectomy for PHPT.
• Measuring Left Ventricular Mass Index [ Time Frame: It will be assessed before surgery and at 3, 6 and 12 months after parathyroidectomy ]
  Cardiovascular system will be evaluated by measuring Left Ventricular Mass Index (LVMI)
• Assessing muscle strength. [ Time Frame: It will be assessed before surgery and at 3, 6 and 12 months after parathyroidectomy ]
  The investigators will assess muscle strength using isokinetic dynamometers

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Measuring the levels of hs-CRP [ Time Frame: It will be assessed before surgery and at 3, 6 and 12 months after parathyroidectomy ]
  Concerning evaluation of cardiovascular system, the investigators will also appraise the levels of hs-CRP
• Monitoring patients' blood pressure for 24 hours. [ Time Frame: It will be assessed before surgery and at 3, 6 and 12 months after parathyroidectomy ]
  Concerning evaluation of cardiovascular system, the investigators will also monitor patients' blood pressure for 24 hours.
• Neurological assessment [ Time Frame: It will be assessed before surgery and at 3, 6 and 12 months after parathyroidectomy ]
  The investigators will conduct neurological clinical examination and assess motor nerve conduction velocity, using electroneurography and neuromuscular junction, using electromyography
• Assessing quality of life [ Time Frame: It will be assessed before surgery and at 3, 6 and 12 months after parathyroidectomy ]
  Pasiekas' questionnaire will be used to assess participant's quality of life.
• Assessing physical activity [ Time Frame: It will be assessed before surgery and at 3, 6 and 12 months after parathyroidectomy ]
  International Physical Activity questionnaire will be used to assess participant's physical activity.

Original Secondary Outcome: Same as current

Information By: Aristotle University Of Thessaloniki

Dates:
Date Received: March 3, 2017
Date Started: December 25, 2016
Date Completion: December 31, 2018
Last Updated: March 21, 2017
Last Verified: March 2017