Object Assessment of Improvement in Non-Specific Symptoms After Parathyroidectomy for Primary Hyperparathyroidism

NCT ID: NCT06337825

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-19
• Study Completion Date: 2024-06-29

Brief Summary

Wearable electronic devices are becoming more prevalent in daily life, as they offer real time information on physiological parameters such as heart rate, activity level, oxygenation, and sleep patterns for their users. These wearable electronic devices are easy to install and offer no major risk or discomfort to the user. Implementation of these technologies into medicine has exponentially grown in the past decade with supporting evidence for their use in cardiovascular disease and sleep medicine. The investigators believe that these devices will be able to capture the changes associated with improvement in non-specific symptoms that have not been previously demonstrated.

Detailed Description

Primary hyperparathyroidism (PHPT) may be more common than previously assumed.1 Historically, osteoporosis and nephrolithiasis were the only two indications for parathyroidectomy (PTX) based on symptomology.2 All other patients, even in the presence of non-specific symptoms related to PHPT, were not routinely recommended for surgery. Nowadays, however, there is increased understanding that a patient's quality of life (QOL) may be adversely affected by these non-specific symptoms.3 The American Association of Endocrine Surgeons (AAES) strongly recommends PTX in patients with these non-specific symptoms if they can be attributed to PHPT.4 Despite this, these neuropsychiatric, musculoskeletal, and gastrointestinal symptoms are overall difficult to quantify and the improvements in symptoms are mostly measured with QOL surveys.

Even QOL surveys are subjective, and therefore, this may be a major barrier in broadening the indications for parathyroidectomy in patients with PHPT. To this day, there is no proposed objective metrics to quantify these improvements after parathyroidectomy.

Furthermore, the effect of PHPT on cardiovascular risk has been studied, but so far the results are conflicting. The mechanisms for this increased cardiovascular risk are not fully understood.

Nonetheless, this population demonstrates higher rates of hypertension, dyslipidemia, obesity, diabetes, and atherosclerosis compared to the general population. On the other hand, depression and sleep disturbances are also known factors for these comorbidities. It is possible that the neuropsychiatric symptoms of PHPT may contribute to a sedentary lifestyle and thus increase the cardiovascular risk. The association between these two have not been studied.

Conditions

Primary Hyperparathyroidism; Multinodular Goiter

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

40 patients with primary hyperparathyroidism

patients undergoing parathyroidectomy for primary hyperparathyroidism

Activity Tracker (Fitbit)

Intervention Type: BEHAVIORAL

Wearable, activity tracker

HbA1C

Intervention Type: DIAGNOSTIC_TEST

Average blood glucose (sugar) levels reported as a percentage

The PROMPT Questionnaire

Intervention Type: BEHAVIORAL

The PROMPT Questionnaire which is a 30-question previously validated assessment for non-specific symptoms in PHPT, will be administered to patients preoperatively and at 2-weeks and 6-months postoperatively

40 patients with multinodular goiters

patients undergoing thyroidectomy for multinodular goiter

Activity Tracker (Fitbit)

Intervention Type: BEHAVIORAL

Wearable, activity tracker

HbA1C

Intervention Type: DIAGNOSTIC_TEST

Average blood glucose (sugar) levels reported as a percentage

The PROMPT Questionnaire

Intervention Type: BEHAVIORAL

The PROMPT Questionnaire which is a 30-question previously validated assessment for non-specific symptoms in PHPT, will be administered to patients preoperatively and at 2-weeks and 6-months postoperatively

Interventions

Activity Tracker (Fitbit)

Wearable, activity tracker

Intervention Type: BEHAVIORAL

HbA1C

Average blood glucose (sugar) levels reported as a percentage

Intervention Type: DIAGNOSTIC_TEST

The PROMPT Questionnaire

The PROMPT Questionnaire which is a 30-question previously validated assessment for non-specific symptoms in PHPT, will be administered to patients preoperatively and at 2-weeks and 6-months postoperatively

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Study group: Consecutive patients older than 18 years old who will undergo PTX for PHPT. The indications and need for surgery will be independent from the research team.
• Control group: Consecutive patients older than 18 years old who will undergo thyroidectomy for multinodular goiter (MNG). The indications and need for surgery will be independent from the research team.

Exclusion Criteria

• Patients with recurrent or persistent PHPT will not be included.
• Patients who are included but have evidence of recurrent or persistent PHPT based on six-month laboratory workup will be excluded from the final analysis (<5% expected)4.
• Established diagnosis of thyroid cancer or Graves' disease.
• Musculoskeletal or neurologic disorders that affect the patient's activity level.
• Cardiac arrhythmias that would interfere with the wearable electronic device measurement.
• Sleep apnea and other sleep disturbances undergoing concurrent treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judy Jin, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

22-727

Identifier Type: -

Identifier Source: org_study_id