NCT05377268 The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control
| NCT ID | NCT05377268 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-03-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Lipohypertrophy is swelling of the fatty tissue located below the skin ("subcutaneous tissue") where many patients with diabetes inject their insulin. Lipohypertrophy can sometimes be felt as firm swelling, lumps or small bumps near insulin injection sites. Previous studies have shown that injecting insulin into areas of lipohypertrophy can affect how insulin is absorbed, and can increase insulin requirements in patients. New data suggest that lipohypertrophy can be detected using ultrasound technology. The ultrasonographic presence of changes to the subcutaneous tissue without swelling that can be felt ("subclinical lipohypertrophy") and the effect of injecting insulin into these sites is unknown. 100 people will participate in the Phase 1 of this study. In the second phase of the study, 40 patients identified with subclinical lipohypertrophy in Phase 1 will be asked to participate in the randomized study using crossover design by checking your glucose levels.
Eligibility Criteria
Inclusion Criteria: * Subjects with a diagnosis of Type 1 or Type 2 diabetes mellitus * Current treatment with a minimum of one insulin injection daily or insulin pump for at least 2 years Exclusion Criteria: * Subjects taking a glucagon-like peptide-1 agonist or a systemic glucocorticoid * Past history of a non-lipohypertrophic dermatological condition in the insulin injection site area
Frequently Asked Questions
Who can join the NCT05377268 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 80 Years, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05377268 currently recruiting?
Yes, NCT05377268 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of British Columbia to inquire about joining.
Where is the NCT05377268 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT05377268 clinical trial?
NCT05377268 is sponsored by University of British Columbia. The trial plans to enroll 100 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.