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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Lipohypertrophy

Intervention / Treatment
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* Drug: Insulin lispro


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Subclinical Lipohypertrophy<br>Insulin lispro will be injected in the abdomen into an area of subclinical lipohypertrophy. | Drug: Insulin lispro<br>* Insulin lispro will be injected into the abdomen into an area of subclinical lipohypertrophy or an area with no subclinical lipohypertrophy<br>|
| Other: No Subclinical Lipohypertrophy<br>Insulin lispro will be injected in the abdomen into an area where there is no subclinical lipohypertrophy. | Drug: Insulin lispro<br>* Insulin lispro will be injected into the abdomen into an area of subclinical lipohypertrophy or an area with no subclinical lipohypertrophy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Levels | The euglycemic clamp technique will be used. Insulin levels will be analyzed by Eliza assay | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Insulin, Lipohypertrophy, Euglycemic Clamp