Primary HyperparathyroidismNCT06337825
Object Assessment of Improvement in Non-Specific Symptoms After Parathyroidectomy for Primary Hyperparathyroidism
An observational study of Primary Hyperparathyroidism and Multinodular Goiter, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperparathyroidism, Multinodular Goiter
- What is being tested?
- Activity Tracker (Fitbit), HbA1C and The PROMPT Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2022to 29 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients referred by other physicians for surgical treatment of PHPT and MNG will be identified in the outpatient schedule of our six endocrine surgeons at the Department of Endocrine Surgery, Endocrine and Metabolism Institute. The research team will be introduced to the patients via My Chart where we will request permission for a phone call to discuss the research study. Once they agree to participate, the recruitment will be done at the outpatient clinic in the Endocrine and Metabolism Institute at Main Campus on the day of their appointment. The need for surgery will be made by the treating surgeon with no involvement of the research team. The recruitment will be done by a member of the research team at the endocrine surgery center (F-20).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
About this study
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.
Read the 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
- Being tested
- Activity Tracker (Fitbit), HbA1C, The PROMPT Questionnaire
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity Tracker (Fitbit)Behavioural
Wearable, activity tracker
HbA1CDiagnostic test
Average blood glucose (sugar) levels reported as a percentage
The PROMPT QuestionnaireBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 40 patients with primary hyperparathyroidism | patients undergoing parathyroidectomy for primary hyperparathyroidism Receives: Behavioral: Activity Tracker (Fitbit); Diagnostic Test: HbA1C; Behavioral: The PROMPT Questionnaire | |
| 40 patients with multinodular goiters | patients undergoing thyroidectomy for multinodular goiter Receives: Behavioral: Activity Tracker (Fitbit); Diagnostic Test: HbA1C; Behavioral: The PROMPT Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resting heart rate over time among study participants as monitored by fitness tracker
To assess the change in resting heart rate before and after parathyroidectomy in patients with Primary hyperparathyroidism
Measured: 7 months
Change in number of awakenings during sleep over time among study participants as monitored by fitness tracker
To assess the change in number of awakenings during sleep before and after parathyroidectomy in patients with Primary hyperparathyroidism
Measured: 7 months
Change in % Deep Sleep over Total Sleep Minutes over time among study participants as monitored by fitness tracker
To assess the change in % Deep Sleep over Total Sleep Minutes before and after parathyroidectomy in patients with Primary hyperparathyroidism
Measured: 7 months
Change in steps over time among study participants as monitored by fitness tracker
To assess the change in steps before and after parathyroidectomy in patients with Primary hyperparathyroidism
Measured: 7 months
Change in total active minutes over time among study participants as monitored by fitness tracker
To assess the change in total active minutes before and after parathyroidectomy in patients with Primary hyperparathyroidism
Measured: 7 months
Change in% Active Calorie over Total Calories over time among study participants as monitored by fitness tracker
To assess the change in % Active Calorie over Total Calories before and after parathyroidectomy in patients with Primary hyperparathyroidism
Measured: 7 months
Change in glucose levels (HbA1C)
To assess the change glucose control before and after parathyroidectomy in patients with Primary hyperparathyroidism.
Measured: 7 months
Correlation of Quality of Life surveys with the PROMPT survey
To correlate the measurements of patient health parameters with quality of life surveys before and after parathyroidectomy. This survey is comprised of 30 questions each with a 1 - 5 rating scale where lower scores indicate less pain, fatigue, soreness and higher scores indicate more fatigue, pain, soreness etc.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start19 Jul 2022
- Primary completion12 Mar 2024
- Study completion29 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judy Jin, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337825
- Sponsor's protocol ID
- 22-727
- Status last verified
- Aug 2024
- First submitted
- 12 Mar 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Object Assessment of Improvement in Non-Specific Symptoms After Parathyroidectomy for Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT06337825
- Acronym / sponsor ID
- 22-727
- Conditions
- Primary Hyperparathyroidism, Multinodular Goiter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 29 Jun 2024 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40 patients with primary hyperparathyroidism | – | Behavioral: Activity Tracker (Fitbit), Diagnostic Test: HbA1C, Behavioral: The PROMPT Questionnairepatients undergoing parathyroidectomy for primary hyperparathyroidism |
| 40 patients with multinodular goiters | – | Behavioral: Activity Tracker (Fitbit), Diagnostic Test: HbA1C, Behavioral: The PROMPT Questionnairepatients undergoing thyroidectomy for multinodular goiter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients referred by other physicians for surgical treatment of PHPT and MNG will be identified in the outpatient schedule of our six endocrine surgeons at the Department of Endocrine Surgery, Endocrine and Metabolism Institute. The research team will be introduced to the patients via My Chart where we will request permission for a phone call to discuss the research study. Once they agree to participate, the recruitment will be done at the outpatient clinic in the Endocrine and Metabolism Institute at Main Campus on the day of their appointment. The need for surgery will be made by the treating surgeon with no involvement of the research team. The recruitment will be done by a member of the research team at the endocrine surgery center (F-20).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity Tracker (Fitbit)Wearable, activity tracker | Behavioural | 40 patients with multinodular goiters, 40 patients with primary hyperparathyroidism |
| HbA1CAverage blood glucose (sugar) levels reported as a percentage | Diagnostic test | 40 patients with multinodular goiters, 40 patients with primary hyperparathyroidism |
| The PROMPT QuestionnaireThe 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 | Behavioural | 40 patients with multinodular goiters, 40 patients with primary hyperparathyroidism |
Primary outcome
Change in resting heart rate over time among study participants as monitored by fitness tracker
Time frame: 7 months
To assess the change in resting heart rate before and after parathyroidectomy in patients with Primary hyperparathyroidism
Change in number of awakenings during sleep over time among study participants as monitored by fitness tracker
Time frame: 7 months
To assess the change in number of awakenings during sleep before and after parathyroidectomy in patients with Primary hyperparathyroidism
Change in % Deep Sleep over Total Sleep Minutes over time among study participants as monitored by fitness tracker
Time frame: 7 months
To assess the change in % Deep Sleep over Total Sleep Minutes before and after parathyroidectomy in patients with Primary hyperparathyroidism
Change in steps over time among study participants as monitored by fitness tracker
Time frame: 7 months
To assess the change in steps before and after parathyroidectomy in patients with Primary hyperparathyroidism
Change in total active minutes over time among study participants as monitored by fitness tracker
Time frame: 7 months
To assess the change in total active minutes before and after parathyroidectomy in patients with Primary hyperparathyroidism
Change in% Active Calorie over Total Calories over time among study participants as monitored by fitness tracker
Time frame: 7 months
To assess the change in % Active Calorie over Total Calories before and after parathyroidectomy in patients with Primary hyperparathyroidism
Change in glucose levels (HbA1C)
Time frame: 7 months
To assess the change glucose control before and after parathyroidectomy in patients with Primary hyperparathyroidism.
Correlation of Quality of Life surveys with the PROMPT survey
Time frame: 7 months
To correlate the measurements of patient health parameters with quality of life surveys before and after parathyroidectomy. This survey is comprised of 30 questions each with a 1 - 5 rating scale where lower scores indicate less pain, fatigue, soreness and higher scores indicate more fatigue, pain, soreness etc.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Primary Hyperparathyroidism
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Primary Hyperparathyroidism
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Flurpiridaz F-18 PET/CT Imaging for Detecting Parathyroid Adenomas
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Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
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Enrolling by invitationObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy Jin, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hyperparathyroidism and Multinodular Goiter, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in resting heart rate over time among study participants as monitored by fitness tracker (time frame: 7 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.