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

Not Applicable

Suspended

• Conditions: Diabetes Mellitus; Lipohypertrophy
• Interventions: Drug: Insulin lispro

• Registration Number: NCT03229850
• Lead Sponsor: Graydon Meneilly

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.

Study Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-07-24
• Study First Posted: 2017-07-26
• Study Start: 2021-02-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 10

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Subclinical Lipohypertrophy	Insulin lispro	Insulin lispro will be injected in the abdomen into an area of subclinical lipohypertrophy.
No Subclinical Lipohypertrophy	Insulin lispro	Insulin lispro will be injected in the abdomen into an area where there is no subclinical lipohypertrophy.

Primary Outcome Measures

Name	Time	Method
Insulin Levels	2 months	The euglycemic clamp technique will be used. Insulin levels will be analyzed by Eliza assay

Trial Locations

Locations (1)

University of British Columbia - Gerontology Research Lab; 🇨🇦 Vancouver, British Columbia, Canada