Ultrasound Detection and Characterization of Subclinical Hypertrophy in Diabetes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2025-04-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Ultra-portable Ultrasound in General Practice

NCT04127149

Pneumonia Pleural Effusion Renal Colic +5 more

COMPLETED NA

Imaging of Soft Tissues

NCT00796094

Soft Tissue Injury

COMPLETED

Can Ultrasound be Used as a Measure of Muscle Quality? A Validation Study Comparing Ultrasound With MRI and MRS in Older and Younger Persons.

NCT05729880

Muscle Atrophy

COMPLETED

Replaceability of Fluoroscopy and Ultrasound in the Evaluation of Hemidiaphragm Excursion

NCT04098939

Diaphragm Disease

COMPLETED

Thoracic Ultrasound on Acute Pancreatitis

NCT04033549

Acute Pancreatitis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Lipohypertrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound

Abdomen scanned with portable ultrasound to determine presence of subclinical lipohypertrophy.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes