Glycemic Control, Type II Diabetes, Parathyroidectomy

Type 2 Diabetes Clinical Trial

Official title:

Evaluation of Glycemic Control and Changes in Skeletal Profile in Patients With Type II Diabetes Undergoing Parathyroidectomy for Primary Hyperparathyroidism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05761743
• Other study ID #: 22-1407
• Status: Recruiting
• Start date: February 27, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: The Cleveland Clinic
• Contact: Kimberly Jenkins, MSNM
• Phone: (216) 445-4791
• Email: JENKINK[@]ccf.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. 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.

Exclusion Criteria:

1. Patients with recurrent or persistent PHPT will not be included.

2. 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.

3. Patients with type 1 diabetes mellitus

4. Patients with secondary and/or tertiary hyperparathyroidism

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Primary Hyperparathyroidism
• Type 2 Diabetes

Intervention

Diagnostic Test:
• Urine and Blood Test
Urine N-telopeptide and serum osteocalcin

Locations

Country	Name	City	State
United States	Cleveland Clinic Main Campus	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	1 year