Clinical trial NCT02348099: Ultrasound Detection and Characterization of Subclinical Hypertrophy in Diabetes
Official title: Ultrasound Guided Detection and Characterization of Subclinical Lipohypertrophy in Type 1 and Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes
Lipohypertrophy
Keywords: Diabetes
Lipohypertrophy
Ultrasound
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People age 19 and over with type 1 or type 2 diabetes who take insulin to manage their diabetes.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Presence of Subclinical Lipohypertrophy
timeFrame: Assessed one time only at the time of clinic visit
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Graydon Meneilly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kapeluto JE, Paty BW, Chang SD, Meneilly GS. Ultrasound detection of insulin-induced lipohypertrophy in Type 1 and Type 2 diabetes. Diabet Med. 2018 Oct;35(10):1383-1390. doi: 10.1111/dme.13764. Epub 2018 Jul 16.