Ultrasound Detection and Characterization of Subclinical Hypertrophy in Diabetes

NCT02348099 | Terminated Results

• 1 other identifier: H14-02461
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Lipohypertrophy

Keywords

Diabetes; Lipohypertrophy; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Presence of Subclinical Lipohypertrophy

  Lipohypertrophy seen on ultrasound but not felt by palpation

  Assessed one time only at the time of clinic visit

Interventions

Ultrasound OTHER

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years of age or older
• Type 1 or Type 2 diabetes
• Using insulin to manage diabetes for at least 2 years

You may not qualify if:

• Using insulin pumps, insulin secretagogues, Glucagon-Like Peptide-1 (GLP-1) agonists to manage diabetes
• Use of immunosuppressant agents
• Women who are pregnant

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (1)

• 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.

  PMID: 29908078 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Results Point of Contact

• Title: Mr Boris Feldman, Research Associate
• Organization: Gerontology Research Lab

boris.feldman@vch.ca

16048755115

Study Officials

• Graydon Meneilly, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, UBC Department of Medicine

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: January 28, 2015
• Study Start: March 1, 2015
• Primary Completion: February 8, 2021
• Study Completion: April 22, 2025
• Last Updated: May 7, 2025
• Results First Posted: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)