Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05761743

Glycemic Control, Type II Diabetes, Parathyroidectomy

The purpose of this study is to assess glycemic control after parathyroidectomy in patients with primary hyperparathyroidism and concomitant type 2 diabetes mellitus.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

urine and blood test

Diagnostic Test

Urine N-telopeptide and serum osteocalcin

Primary outcomes

  1. 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.

Secondary outcomes

  1. Assess the changes in skeletal profile 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 9, 2023
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.