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

Graydon Meneilly

Status: Withdrawn

Conditions: Diabetes Mellitus; Lipohypertrophy

Treatments: Drug: Insulin lispro

Study type: Interventional

Funder types: Other

Identifiers

NCT03229850

H17-01270

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

0 participants in 2 patient groups

Subclinical Lipohypertrophy

Other group

Description:

Insulin lispro will be injected in the abdomen into an area of subclinical lipohypertrophy.

Treatment:

Drug: Insulin lispro

No Subclinical Lipohypertrophy

Other group

Description:

Insulin lispro will be injected in the abdomen into an area where there is no subclinical lipohypertrophy.

Treatment:

Drug: Insulin lispro