Skip to content

Dynamics of Insulin Absorption in Subclinical Lipohypertrophy Using the Euglycemic Clamp Technique

Dynamics of Insulin Absorption in Subclinical Lipohypertrophy Using the Euglycemic Clamp Technique

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03229850
Enrollment
0
Registered
2017-07-26
Start date
2021-02-01
Completion date
2025-04-22
Last updated
2025-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Lipohypertrophy

Keywords

Diabetes, Insulin, Lipohypertrophy, Euglycemic Clamp

Brief summary

This study will use the euglycemic clamp technique to evaluate insulin absorption when insulin is administered subcutaneously in an area of subclinical lipohypertrophy vs an area of normal tissue.

Detailed description

The use of insulin to manage diabetes can cause changes to the skin at sites where insulin is administered. These changes may be felt as lumps under the skin. Insulin injected into these areas may not work as well leading to needing increasing doses of insulin to control blood glucose levels. Hypoglycemia can occur when insulin is injected into normal areas. Previous studies have found that these lipohypertrophic areas can be seen on ultrasound before they can be felt. The Investigators will be using the euglycemic clamp techique to evaluate insulin absorption to see whether tissue with lumps that cannot be felt but are seen on ultrasound affect how insulin is absorbed.

Interventions

DRUGInsulin lispro

Insulin lispro will be injected into the abdomen into an area of subclinical lipohypertrophy or an area with no subclinical lipohypertrophy

Sponsors

Graydon Meneilly
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

During one euglycemic clamp study, insulin lispro will be injected subcutaneously into an area of subclinical lipohypertrophy of the abdomen identified by ultrasound, during the other insulin lispro will be injected to an area with no subclinical lipohypertrophy.

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Participated in Glycemic Variability study * Type 2 Diabetes for at least 2 years * Currently using insulin to manage diabetes * Have used insulin to manage diabetes for at least 2 years * Age 19 or older * BMI \< 30 kg/m2 * Confirmed areas of subclinical lipohypertrophic adipose tissue lesions via ultrasound

Exclusion criteria

* Taking other injectable medications (eg liraglutide/Victoza * Taking systemic steroids (ie prednisone) * Severe renal insufficiency (eGFR \< 30 ml/min/1.73 m2 * Hypoglycemic unawareness * Current pregnancy * Not fluent in speaking and writing English (unless accompanied by a translator)

Design outcomes

Primary

MeasureTime frameDescription
Insulin Levels2 monthsThe euglycemic clamp technique will be used. Insulin levels will be analyzed by Eliza assay

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026