DiabetesNCT02348099
Ultrasound Detection and Characterization of Subclinical Hypertrophy in Diabetes
An observational study of Diabetes and Lipohypertrophy, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Lipohypertrophy
- What is being tested?
- Ultrasound
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to 22 Apr 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People age 19 and over with type 1 or type 2 diabetes who take insulin to manage their diabetes.
Who may be able to join
- 19 years of age or older
- Type 1 or Type 2 diabetes
- Using insulin to manage diabetes for at least 2 years
Who cannot join
- Using insulin pumps, insulin secretagogues, Glucagon-Like Peptide-1 (GLP-1) agonists to manage diabetes
- Use of immunosuppressant agents
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Detection and Characterization of Subclinical Lipohypertrophy in Type 1 and Type 2 Diabetes Mellitus
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.
Read the 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.
- Conditions
- Diabetes, Lipohypertrophy
- Being tested
- Ultrasound
- Keywords
- Diabetes, Lipohypertrophy, Ultrasound
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundOther
Abdomen scanned with portable ultrasound to determine presence of subclinical lipohypertrophy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Presence of Subclinical Lipohypertrophy
Lipohypertrophy seen on ultrasound but not felt by palpation
Measured: Assessed one time only at the time of clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startMar 2015
- Primary completion8 Feb 2021
- Study completion22 Apr 2025
Why it stopped: The study run its course
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Graydon Meneilly, University of British Columbia
- Investigators
- Graydon Meneilly, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348099
- Sponsor's protocol ID
- H14-02461
- Status last verified
- Apr 2025
- First submitted
- 21 Jan 2015
- Last updated
- 7 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29908078
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Detection and Characterization of Subclinical Lipohypertrophy in Type 1 and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02348099
- Acronym / sponsor ID
- H14-02461
- Conditions
- Diabetes, Lipohypertrophy
- Keywords
- Diabetes, Lipohypertrophy, Ultrasound
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study run its course
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Posted 4 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People age 19 and over with type 1 or type 2 diabetes who take insulin to manage their diabetes.
Key inclusion criteria (3 listed)
- 19 years of age or older
- Type 1 or Type 2 diabetes
- Using insulin to manage diabetes for at least 2 years
Key exclusion criteria (3 listed)
- Using insulin pumps, insulin secretagogues, Glucagon-Like Peptide-1 (GLP-1) agonists to manage diabetes
- Use of immunosuppressant agents
- Women who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundAbdomen scanned with portable ultrasound to determine presence of subclinical lipohypertrophy. | Other | – |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29908078Kapeluto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graydon Meneilly, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Lipohypertrophy, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Presence of Subclinical Lipohypertrophy (time frame: Assessed one time only at the time of clinic visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02348099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.