Primary HyperparathyroidismNCT05761743
Glycemic Control, Type II Diabetes, Parathyroidectomy
An observational study of Primary Hyperparathyroidism and Type 2 Diabetes, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to assess glycemic control after parathyroidectomy in patients with primary hyperparathyroidism and concomitant type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperparathyroidism, Type 2 Diabetes
- What is being tested?
- Urine and Blood Test
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2023to 1 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from a multi-specialty academic medical center coming in to see their physician for surgery, and/or management of their PHPT and DM.
Who may be able to join
- Study group: Consecutive patients older than 18 years old with concomitant PHPT and DM who will undergo PTX. The indications and need for surgery will be independent from the research team.
- Control group: Consecutive patients older than 18 years old with concomitant PHPT and DM who will not undergo PTX. The indications to forgo 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)9.
- Patients with type 1 diabetes mellitus
- Patients with secondary and/or tertiary hyperparathyroidism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Glycemic Control and Changes in Skeletal Profile in Patients With Type II Diabetes Undergoing Parathyroidectomy for Primary Hyperparathyroidism
The purpose of this study is to assess glycemic control after parathyroidectomy in patients with primary hyperparathyroidism and concomitant type 2 diabetes mellitus.
Read the detailed description
Primary hyperparathyroidism (PHPT) is known to affect the kidney and skeletal system, however, recent data have suggested that patients can also exhibit an increased cardiovascular risk and metabolic abnormalities Primary hyperparathyroidism (PHPT) is the most common cause of hypercalcemia, with an estimated prevalence of 0.8% in the general population. Type 2 diabetes mellitus (DM) is the most prevalent chronic disease with an estimated prevalence of 10%. Based on the estimated prevalence of this two conditions, we would expect a comorbid prevalence of both diseases in the same individual of approximately 0.08%. However, the prevalence of DM in patients with PHPT is much higher ranging from anywhere 7.8% to 22%, suggesting that this is not mere coincidence.
While the exact mechanism is not clear, in vivo study demonstrated that parathyroid hormone (PTH) reduces the insulin-stimulated uptake as well as decrease glucose transporter and the insulin receptor. Hypercalcemia can also be associated with impaired insulin sensitivity and insufficient suppression of gluconeogenesis. In some patient series, some improvement in glycemic profiles have been shown in patients after parathyroidectomy (PTX).
In addition, both DM and PHPT are known risk factors for the development of bone abnormality patients with DM have increased risk of hip fractures while cortical bone (i.e. the forearm) are more commonly affected in patients with PHPT. There are currently very few studies evaluating the interaction of both conditions in terms of patient skeletal profiles and bone health.
Participants with PHPT and DM will be recruited and followed over the course of a year. There are two groups: the group of patients that decided to pursue a parathyroidectomy, and a group of patients that will be managed non-surgically. Clinical data will be collected along with blood tests.
- Conditions
- Primary Hyperparathyroidism, Type 2 Diabetes
- Being tested
- Urine and Blood Test
- Keywords
- Hyperparathyroidism, Glycemic Control
- Medical subject headings
- Hyperparathyroidism, Primary, Diabetes Mellitus, Type 2, Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine and Blood TestDiagnostic test
Urine N-telopeptide and serum osteocalcin
| Study group | Role | What they receive |
|---|---|---|
| PHPT and DM Patients, Parathyroidectomy | Patients with primary hyperparathyroidism with type 2 diabetes, that decided with their physician/surgeon to continue with a parathyroidectomy (independent of research). Receives: Diagnostic Test: Urine and Blood Test | |
| PHPT and DM Patients, NO Parathyroidectomy | Patients with primary hyperparathyroidism with type 2 diabetes, that have decided with their physician/surgeon to be managed medically with no parathyroidectomy. Receives: Diagnostic Test: Urine and Blood Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess glycemic control after parathyroidectomy in patients with primary hyperparathyroidism and concomitant type 2 diabetes mellitus
Preoperative, operative and postoperative variables will be compared between groups using the unpaired T-test and Chi-squared test for continuous and categorical variables, respectively. Postoperative differences compared to the baseline will be analyzed using a paired T-test.
Measured: 1 year
Secondary outcomes (1)
Assess the changes in skeletal profile after parathyroidectomy in patients with primary hyperparathyroidism and concomitant type 2 diabetes mellitus
Preoperative, operative and postoperative variables will be compared between groups using the unpaired T-test and Chi-squared test for continuous and categorical variables, respectively. Postoperative differences compared to the baseline will be analyzed using a paired T-test.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start27 Feb 2023
- Primary completion31 Dec 2025
- Study completion1 Aug 2026 (estimated)
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judy Jin, MD, The Cleveland Clinic
- Investigators
- Judy Jin, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761743
- Sponsor's protocol ID
- 22-1407
- Status last verified
- Feb 2026
- First submitted
- 28 Feb 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Glycemic Control and Changes in Skeletal Profile in Patients With Type II Diabetes Undergoing Parathyroidectomy for Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT05761743
- Acronym / sponsor ID
- 22-1407
- Conditions
- Primary Hyperparathyroidism, Type 2 Diabetes
- Keywords
- Hyperparathyroidism, Glycemic Control
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 9 Mar 2023 (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.
The purpose of this study is to assess glycemic control after parathyroidectomy in patients with primary hyperparathyroidism and concomitant type 2 diabetes mellitus.
Detailed description
Primary hyperparathyroidism (PHPT) is known to affect the kidney and skeletal system, however, recent data have suggested that patients can also exhibit an increased cardiovascular risk and metabolic abnormalities Primary hyperparathyroidism (PHPT) is the most common cause of hypercalcemia, with an estimated prevalence of 0.8% in the general population. Type 2 diabetes mellitus (DM) is the most prevalent chronic disease with an estimated prevalence of 10%. Based on the estimated prevalence of this two conditions, we would expect a comorbid prevalence of both diseases in the same individual of approximately 0.08%. However, the prevalence of DM in patients with PHPT is much higher ranging from anywhere 7.8% to 22%, suggesting that this is not mere coincidence.
While the exact mechanism is not clear, in vivo study demonstrated that parathyroid hormone (PTH) reduces the insulin-stimulated uptake as well as decrease glucose transporter and the insulin receptor. Hypercalcemia can also be associated with impaired insulin sensitivity and insufficient suppression of gluconeogenesis. In some patient series, some improvement in glycemic profiles have been shown in patients after parathyroidectomy (PTX).
In addition, both DM and PHPT are known risk factors for the development of bone abnormality patients with DM have increased risk of hip fractures while cortical bone (i.e. the forearm) are more commonly affected in patients with PHPT. There are currently very few studies evaluating the interaction of both conditions in terms of patient skeletal profiles and bone health.
Participants with PHPT and DM will be recruited and followed over the course of a year. There are two groups: the group of patients that decided to pursue a parathyroidectomy, and a group of patients that will be managed non-surgically. Clinical data will be collected along with blood tests.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHPT and DM Patients, Parathyroidectomy | – | Diagnostic Test: Urine and Blood TestPatients with primary hyperparathyroidism with type 2 diabetes, that decided with their physician/surgeon to continue with a parathyroidectomy (independent of research). |
| PHPT and DM Patients, NO Parathyroidectomy | – | Diagnostic Test: Urine and Blood TestPatients with primary hyperparathyroidism with type 2 diabetes, that have decided with their physician/surgeon to be managed medically with no parathyroidectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from a multi-specialty academic medical center coming in to see their physician for surgery, and/or management of their PHPT and DM.
Key inclusion criteria (2 listed)
- Study group: Consecutive patients older than 18 years old with concomitant PHPT and DM who will undergo PTX. The indications and need for surgery will be independent from the research team.
- Control group: Consecutive patients older than 18 years old with concomitant PHPT and DM who will not undergo PTX. The indications to forgo surgery will be independent from the research team.
Key exclusion criteria (4 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)9.
- Patients with type 1 diabetes mellitus
- Patients with secondary and/or tertiary hyperparathyroidism
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 |
|---|---|---|
| Urine and Blood TestUrine N-telopeptide and serum osteocalcin | Diagnostic test | PHPT and DM Patients, NO Parathyroidectomy, PHPT and DM Patients, Parathyroidectomy |
Primary outcome
Assess glycemic control after parathyroidectomy in patients with primary hyperparathyroidism and concomitant type 2 diabetes mellitus
Time frame: 1 year
Preoperative, operative and postoperative variables will be compared between groups using the unpaired T-test and Chi-squared test for continuous and categorical variables, respectively. Postoperative differences compared to the baseline will be analyzed using a paired T-test.
1 secondary outcome
Assess the changes in skeletal profile after parathyroidectomy in patients with primary hyperparathyroidism and concomitant type 2 diabetes mellitus
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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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 Type 2 Diabetes, 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 4 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: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Assess glycemic control after parathyroidectomy in patients with primary hyperparathyroidism and concomitant type 2 diabetes mellitus (time frame: 1 year). 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 26 May 2026.