Investigating the inflammatory response to insulin pump catheters in a tummy tuck model
A Pilot Study for the Systematic Evaluation of the Inflammatory Response to Commercially Available Insulin Infusion Catheters in Subcutaneous Adipose Tissue
NA · Medical University of Graz · NCT03298295
This study is testing how different materials for insulin pump catheters affect inflammation and insulin absorption in people getting a tummy tuck to see if it can help improve diabetes management.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Medical University of Graz (other) |
| Locations | 1 site (Graz) |
| Trial ID | NCT03298295 on ClinicalTrials.gov |
What this trial studies
This study examines the inflammatory response to Continuous Subcutaneous Insulin Infusion (CSII) catheters made from different materials in patients undergoing elective abdominoplasty. The goal is to understand how these responses affect insulin absorption, which can be variable and unreliable, leading to challenges in diabetes management. By comparing the effects of steel and Teflon catheters, the study aims to develop catheters that can be used for longer periods, potentially improving patient outcomes. Participants will be monitored for their insulin absorption rates and any related complications.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18 and older who are scheduled for elective abdominoplasty at the Medical University of Graz.
Not a fit: Patients with allergies to Teflon or steel, skin diseases, or those on immunomodulating therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved insulin absorption and better diabetes management for patients using insulin pumps.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated that material and design can significantly impact the performance of insulin delivery systems.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women, age 18 years or older * Scheduled elective abdominoplasty at the Dpt. of Plastic Surgery, Medical University of Graz * Signed informed consent form Exclusion Criteria: * Allergy to Teflon or steel * Known skin diseases (atopic dermatitis, psoriasis) * History of immunodeficiency diseases * Patients on glucocorticoid or other immunomodulating therapy * History of bleeding disorder * Pregnancy or planned pregnancy * Unable to fully understand study procedures and to provide informed consent
Where this trial is running
Graz
- Division of Plastic, Aesthetic and Reconstructive Surgery — Graz, Austria (RECRUITING)
Study contacts
- Principal investigator: Lars-Peter Kamolz, MD Prof — Medical University of Graz
- Study coordinator: Jasmin R Hauzenberger, MSc
- Email: jasmin.hauzenberger@medunigraz.at
- Phone: +436645172277
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.
Conditions: Diabetes Mellitus, Insulin Pump Therapy, Continuous Subcutaneous Insulin Infusion