Diabetes Mellitus, Lipohypertrophy
Conditions
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
Insulin lispro will be injected into the abdomen into an area of subclinical lipohypertrophy or an area with no subclinical lipohypertrophy
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Insulin Levels | 2 months | The euglycemic clamp technique will be used. Insulin levels will be analyzed by Eliza assay |
Countries
Canada