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

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ClinicalTrials.gov Identifier: NCT03091140
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Papavramidis Theodossis, Aristotle University Of Thessaloniki

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.


Condition or disease
Hyperparathyroidism, Primary Parathyroidectomy

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alterations in Muscle's Functional Characteristics After Parathyroid Surgery for Primary Hyperparathyroidism.
Actual Study Start Date : December 25, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018


Group/Cohort
Group A
patients with primary hyperparathyroidism, undergoing parathyroidectomy, as a therapeutic intervention
Group B
patients with primary hyperparathyroidism, not undergoing parathyroidectomy and receiving conservative treatment. This group will be considered as control group.
Group C
patients undergoing thyroid surgery due to nontoxic multinodular goiter or solitary nontoxic thyroid adenoma. This group will be considered as control group.
Group D
healthy subjects. This group will be considered as control group.



Primary Outcome Measures :
  1. 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.

  2. 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)

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study is designed as a multi-center, observational, cohort study. Any patient that has indication for a parathyroidectomy due to primary hyperparathyroidism will be considered eligible.
Criteria

Inclusion Criteria:

  1. Patient is over 18 years old
  2. Patient scheduled for a non-emergency operation
  3. Patients diagnosed with PHPT:

    i) one or more samples of total serum calcium above the upper limit of normal value for the laboratory (hypercalcemia) ii) serum albumin within the normal range iii) hypercalcemia with normal or elevated PTH levels iv) serum 25(OH) vitamin D more than 20 ng/ml (50nmol/lt)

  4. Patient eligible for parathyroid surgery: PHPT with one or more of the following i) age less than 50 years ii) serum calcium level more than 1mg/dl above the upper limit of normal iii) T score of less than -2.5 at any site, or non traumatic osteoporotic fracture by history or VFA (Vertebral Fracture Assessment) iv) history of renal colic or evidence of lithiasis/calcinosis by x-Ray or ultrasound v) creatinine clearance of less than 60ml/min vi) hypercalciuria (more than 400mg/ day)
  5. Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures

Exclusion Criteria:

  1. Patient is participating in another clinical trial which may affect this study's outcomes
  2. Patient with recurrent hyperparathyroidism
  3. Previous operation at the thyroid and parathyroid glands or neck irradiation
  4. Noneuthyroid condition
  5. Primary hyperparathyroidism due to hyperplasia or multiple adenomas
  6. Secondary hyperparathyroidism
  7. Primary or secondary hypoparathyroidism
  8. Diabetes mellitus
  9. Chronic renal failure
  10. Systemic diseases (e.g. infections, neoplasms)
  11. Hypoalbuminemia
  12. Use of drugs that influences calcium metabolism (Vitamin D analogues, oral calcium supplements, bisphosphonates, teriparatide, thiazide diuretics, aromatase inhibitors)
  13. Known neuromuscular disorders due to other causes
  14. Factors affecting acoustic reflex:

    i) Conductive or sensorineural hearing loss (hearing threshold better than 80dBs (decibells) in every testing frequency) ii) Otosclerosis iii) Middle ear dysfunction (acute or chronic inflammation) iv) Facial nerve dysfunction v) Retrocochlear damage (acoustic neurinoma, vestibular Schwannoma) vi) Impaired stapedius muscle


Information from the National Library of Medicine

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): NCT03091140


Contacts
Contact: Theodossis Papavramidis, Ass. Professor 00306944536972 papavramidis@hotmail.com

Locations
Greece
AHEPA University General Hospital, Aristotle University of Thessaloniki Recruiting
Thessaloniki, Greece, 54621
Contact: Theodossis Papavramidis, Assistant Professor    00306944536972    papavramidis@hotmail.com   
Principal Investigator: Ioannis Pliakos, Academic Fellow         
Principal Investigator: Antonios Michalopoulos, Professor         
Principal Investigator: Georgios Efthimiadis, Assistant Professor         
Principal Investigator: Haralambos Karvounis, Professor         
Sub-Investigator: Angeliki Chorti, Medical Student         
Sub-Investigator: Aristi Boulmpou, Medical Student         
Sub-Investigator: Samer Abu-farha, Resident         
Sub-Investigator: Thomas Zegkos, Resident         
Sub-Investigator: Triantafyllia Boutsiadou, Resident         
Principal Investigator: Georgios Tzikos, Academic Fellow         
Principal Investigator: Evangelia Boura, Academic Fellow         
Principal Investigator: Anna Zisi, Academic Fellow         
Principal Investigator: Evaggelos Sikaras, Academic Fellow         
Principal Investigator: Fotios Economou, Academic Fellow         
Sub-Investigator: Eleni Semaltianou, Academic Fellow         
Sub-Investigator: Ioannis Tziatzios, Academic Fellow         
Sub-Investigator: Christina Manani, Academic Fellow         
Principal Investigator: Fotini Adamidou, Academic Fellow         
Principal Investigator: Konstantinos Toulis, Academic Fellow         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Study Director: Theodossis Papavramidis, Ass. Professor 1st Propedeutic Department of Surgery, AHEPA University General Hospital, Aristotle University of Thessaloniki

Publications:

Responsible Party: Papavramidis Theodossis, Assistant Professor of Surgery, Aristotle University of Thessaloniki, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT03091140     History of Changes
Other Study ID Numbers: 29th SesTop/31stCon/21.12.2016
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
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

Keywords provided by Papavramidis Theodossis, Aristotle University Of Thessaloniki:
Parathyroidectomy
Muscular Functional Characteristics
Parathyroid Glands

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases