NCT06337825

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
BEHAVIORAL	Activity Tracker (Fitbit)	Wearable, activity tracker
DIAGNOSTIC_TEST	HbA1C	Average blood glucose (sugar) levels reported as a percentage
BEHAVIORAL	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

Timeline

• Start date: 2022-07-19
• Primary completion: 2024-03-12
• Completion: 2024-06-29
• First posted: 2024-03-29
• Last updated: 2024-08-06

Locations

1 site across 1 country: United States