Trial Outcomes & Findings for Ultrasound Detection and Characterization of Subclinical Hypertrophy in Diabetes (NCT NCT02348099)

Last Updated: 2025-05-07

Results Overview

Lipohypertrophy seen on ultrasound but not felt by palpation

Recruitment status

TERMINATED

Target enrollment

100 participants

Primary outcome timeframe

Assessed one time only at the time of clinic visit

Results posted on

2025-05-07

Participant milestones
Measure	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.
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Ultrasound Detection and Characterization of Subclinical Hypertrophy in Diabetes

Baseline characteristics by cohort
Measure	Diabetes Patients Treated With Insulin n=100 Participants 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.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=93 Participants
Age, Categorical >=65 years	20 Participants n=93 Participants
Age, Continuous	50 years n=93 Participants
Sex: Female, Male Female	50 Participants n=93 Participants
Sex: Female, Male Male	50 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=93 Participants
Race (NIH/OMB) Asian	25 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	10 Participants n=93 Participants
Race (NIH/OMB) White	30 Participants n=93 Participants
Race (NIH/OMB) More than one race	15 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=93 Participants
Region of Enrollment Canada	100 Participants n=93 Participants
Presence of Lipohypertrophy	100 participants n=93 Participants

Timeframe: Assessed one time only at the time of clinic visit

Population: 100 participants were analyzed for having subclinical lipohypertophy.

Lipohypertrophy seen on ultrasound but not felt by palpation

Outcome measures
Measure	Diabetes Patients Treated With Insulin n=100 Participants 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.
Number of Participants With Presence of Subclinical Lipohypertrophy	20 Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Diabetes Patients Treated With Insulin n=100 participants at risk 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. There may be some discomfort associated with the insertion of the glucose sensor. There is a small risk of skin infection from the insertion of the glucose sensor and catheter and the possibility of an allergic reaction from the tape used to apply it. This risk occurs less than 1 in 1000 times the sensor is used. If patients have concerns regarding insulin dose adjustments they will have access to a diabetes education and research nurse who can assist with insulin dose titration. Any additional adverse events will be monitored by a trained research nurse at the Diabetes Centre.
Skin and subcutaneous tissue disorders Skin infection	1.0% 1/100 • Number of events 1 • During study procedure within study visit up to 1 hour All adverse events will be collected from the enrolled participants by the study staff

Gerontology Research Lab

Phone: 16048755115