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The purpose of this study is to assess glycemic control after parathyroidectomy in patients with primary hyperparathyroidism and concomitant type 2 diabetes mellitus.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urine and Blood Test | Diagnostic Test | Urine N-telopeptide and serum osteocalcin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Judy Jin, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Main Campus | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D049950 | Hyperparathyroidism, Primary |
| D003924 | Diabetes Mellitus, Type 2 |
| D006961 | Hyperparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D014554 | Urination |
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D014553 | Urinary Tract Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| 1 year |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |