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Clinical Trials/NCT02348099
NCT02348099TerminatedNot Applicable

Ultrasound Guided Detection and Characterization of Subclinical Lipohypertrophy in Type 1 and Type 2 Diabetes Mellitus

University of British Columbia1 site in 1 country100 target enrollmentStarted: March 2015Last updated:
Conditions

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Graydon Meneilly

Professor, UBC Department of Medicine

University of British Columbia

Study Sites (1)

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