Ultrasound Guided Detection and Characterization of Subclinical Lipohypertrophy in Type 1 and Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Number of Participants With Presence of Subclinical Lipohypertrophy
Study Overview
Brief Summary
This is a pilot study to enroll 100 people to assess the incidence of lipohypertrophy as detected with ultrasound and its impact on glycemic variability.
Detailed Description
Lipohypertrophy is a well documented phenomenon in patients with diabetes in which hypertrophy and differentiation of adipocytes occurs in the dermal reticular layer at the sites of subcutaneous insulin injection. Currently, lipohypertrophy is assessed by palpating insulin injection sites. The detection on early, non palpable (subclinical) lipohypertrophy remains difficult in the clinical setting. Recent studies have identified distinct ultrasonographic features of hyperechogenicity in areas of adipose tissue consistent with clinical evidence of lipohypertrophy at insulin injection sites, and have detected changes int he thickness of subcutaneous tissue where not clinically evident in population of patients with type 1 diabetes. Lipohypertrophy can adversely affect glycemic control. Injecting into lipohypertrophic areas leads to poor absorption and the need for increasing doses of insulin.
In this study study participants will undergo an assessment for lipohypertrophy during a scheduled visit at the VGH Diabetes Centre. A Diabetes Nurse will assess lipohypertrophy by palpation according to the FIT Protocol. A second diabetes nurse who was not present at the palpation will assess insulin injection sites for lipohypertrophy by ultrasound using a linear probe.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •19 years of age or older
- •Type 1 or Type 2 diabetes
- •Using insulin to manage diabetes for at least 2 years
Exclusion Criteria
- •Using insulin pumps, insulin secretagogues, Glucagon-Like Peptide-1 (GLP-1) agonists to manage diabetes
- •Use of immunosuppressant agents
- •Women who are pregnant
Outcomes
Primary Outcomes
Number of Participants With Presence of Subclinical Lipohypertrophy
Time Frame: Assessed one time only at the time of clinic visit
Lipohypertrophy seen on ultrasound but not felt by palpation
Secondary Outcomes
No secondary outcomes reported
Investigators
Graydon Meneilly
Professor, UBC Department of Medicine
University of British Columbia
