Diabetes, Lipohypertrophy
Conditions
Keywords
Diabetes, Lipohypertrophy, Ultrasound
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.
Interventions
OTHERUltrasound
Abdomen scanned with portable ultrasound to determine presence of subclinical lipohypertrophy.
Sponsors
University of British Columbia
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Presence of Subclinical Lipohypertrophy | Assessed one time only at the time of clinic visit | Lipohypertrophy seen on ultrasound but not felt by palpation |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diabetes Patients Treated With Insulin We propose a pilot study in a minimum of 100 patients with diabetes who have been using insulin therapy for at least two years and being treated with insulin at the time of the study. Patients using insulin pumps, insulin secretagogues (e.g. sulfonylureas), GLP-1 agonists and immunosuppreressant agents will be excluded. Women who are pregnant will be excluded. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Diabetes Patients Treated With Insulin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants |
| Age, Continuous | 50 years |
| Presence of Lipohypertrophy | 100 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants |
| Race (NIH/OMB) Asian | 25 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment Canada | 100 Participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 1 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Number of Participants With Presence of Subclinical Lipohypertrophy
Lipohypertrophy seen on ultrasound but not felt by palpation
Time frame: Assessed one time only at the time of clinic visit
Population: 100 participants were analyzed for having subclinical lipohypertophy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diabetes Patients Treated With Insulin | Number of Participants With Presence of Subclinical Lipohypertrophy | 20 Participants |
Comparison: A student's paired t-test will be used to determine the difference if any in CV of glucose between injection sited.~If the null hypothesis is true, it suggests that any changes witnessed in an experiment are because of random chance and not because of changes made to variables in the experiment. A power calculation is a statistical method used to determine the minimum sample size needed to detect a statistically significant effect of a certain size.p-value: <0.01t-test, 2 sided