Glycemic Control, Type II Diabetes, Parathyroidectomy

NCT05761743 | Active Not Recruiting

• 1 other identifier: 22-1407
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Hyperparathyroidism; Type 2 Diabetes

Keywords

Hyperparathyroidism, Glycemic Control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assess the changes in skeletal profile after parathyroidectomy in patients with primary hyperparathyroidism and concomitant type 2 diabetes mellitus

  1 year

Study Arms (2)

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).

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.

Diagnostic Test: Urine and Blood Test

Interventions

Urine and Blood Test DIAGNOSTIC_TEST

Urine N-telopeptide and serum osteocalcin

PHPT and DM Patients, NO Parathyroidectomy; PHPT and DM Patients, Parathyroidectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary; Diabetes Mellitus, Type 2; Hyperparathyroidism

Interventions

Urination; Hematologic Tests

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Judy Jin, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician in Endocrine Surgery

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 9, 2023
• Study Start: February 27, 2023
• Primary Completion: December 31, 2025
• Study Completion: February 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)