Assessing blood sugar control after parathyroid surgery in diabetes patients
Evaluation of Glycemic Control and Changes in Skeletal Profile in Patients With Type II Diabetes Undergoing Parathyroidectomy for Primary Hyperparathyroidism
This study is testing whether having parathyroid surgery can help improve blood sugar control in adults with type 2 diabetes and high parathyroid hormone levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05761743 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effects of parathyroidectomy on glycemic control in patients suffering from primary hyperparathyroidism and type 2 diabetes mellitus. It will involve two groups: one undergoing surgery and another that will not, with both groups consisting of patients over 18 years old. The study will analyze urine and blood test results to determine any changes in glycemic profiles post-surgery. The research seeks to understand the relationship between parathyroid hormone levels and insulin sensitivity in these patients.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with both primary hyperparathyroidism and type 2 diabetes who are scheduled for parathyroidectomy or who will not undergo surgery.
Not a fit: Patients with type 1 diabetes or those with recurrent or persistent hyperparathyroidism will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of blood sugar levels in patients with both primary hyperparathyroidism and type 2 diabetes.
How similar studies have performed: There have been limited studies on this topic, suggesting that this approach may be novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Main Campus — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Judy Jin, MD — The Cleveland Clinic
- Study coordinator: Kimberly Jenkins, MSNM
- Email: JENKINK@ccf.org
- Phone: (216) 445-4791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.