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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03229850
• Other study ID #: H17-01270
• Status: Suspended
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Lipohypertrophy

Intervention

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

Locations

Country	Name	City	State
Canada	University of British Columbia - Gerontology Research Lab	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Graydon Meneilly

Country where clinical trial is conducted

Canada, 

References & Publications (12)

Blanco M, Hernandez MT, Strauss KW, Amaya M. Prevalence and risk factors of lipohypertrophy in insulin-injecting patients with diabetes. Diabetes Metab. 2013 Oct;39(5):445-53. doi: 10.1016/j.diabet.2013.05.006. Epub 2013 Jul 22. — View Citation

Chowdhury TA, Escudier V. Poor glycaemic control caused by insulin induced lipohypertrophy. BMJ. 2003 Aug 16;327(7411):383-4. doi: 10.1136/bmj.327.7411.383. No abstract available. — View Citation

Famulla S, Hovelmann U, Fischer A, Coester HV, Hermanski L, Kaltheuner M, Kaltheuner L, Heinemann L, Heise T, Hirsch L. Insulin Injection Into Lipohypertrophic Tissue: Blunted and More Variable Insulin Absorption and Action and Impaired Postprandial Glucose Control. Diabetes Care. 2016 Sep;39(9):1486-92. doi: 10.2337/dc16-0610. Epub 2016 Jul 13. — View Citation

Fujikura J, Fujimoto M, Yasue S, Noguchi M, Masuzaki H, Hosoda K, Tachibana T, Sugihara H, Nakao K. Insulin-induced lipohypertrophy: report of a case with histopathology. Endocr J. 2005 Oct;52(5):623-8. doi: 10.1507/endocrj.52.623. — View Citation

Hauner H, Stockamp B, Haastert B. Prevalence of lipohypertrophy in insulin-treated diabetic patients and predisposing factors. Exp Clin Endocrinol Diabetes. 1996;104(2):106-10. doi: 10.1055/s-0029-1211431. — View Citation

Heinemann L, Weyer C, Rauhaus M, Heinrichs S, Heise T. Variability of the metabolic effect of soluble insulin and the rapid-acting insulin analog insulin aspart. Diabetes Care. 1998 Nov;21(11):1910-4. doi: 10.2337/diacare.21.11.1910. — View Citation

Overland J, Molyneaux L, Tewari S, Fatouros R, Melville P, Foote D, Wu T, Yue DK. Lipohypertrophy: does it matter in daily life? A study using a continuous glucose monitoring system. Diabetes Obes Metab. 2009 May;11(5):460-3. doi: 10.1111/j.1463-1326.2008.00972.x. Epub 2009 Feb 19. — View Citation

Raile K, Noelle V, Landgraf R, Schwarz HP. Insulin antibodies are associated with lipoatrophy but also with lipohypertrophy in children and adolescents with type 1 diabetes. Exp Clin Endocrinol Diabetes. 2001;109(8):393-6. doi: 10.1055/s-2001-18991. — View Citation

Schiazza L, Occella C, Bleidl D, Rampini E. Insulin lipohypertrophy. J Am Acad Dermatol. 1990 Jan;22(1):148-9. doi: 10.1016/s0190-9622(08)80037-0. No abstract available. — View Citation

Thow JC, Johnson AB, Marsden S, Taylor R, Home PD. Morphology of palpably abnormal injection sites and effects on absorption of isophane(NPH) insulin. Diabet Med. 1990 Nov;7(9):795-9. doi: 10.1111/j.1464-5491.1990.tb01494.x. — View Citation

Vardar B, Kizilci S. Incidence of lipohypertrophy in diabetic patients and a study of influencing factors. Diabetes Res Clin Pract. 2007 Aug;77(2):231-6. doi: 10.1016/j.diabres.2006.12.023. Epub 2007 Feb 15. — View Citation

Young RJ, Hannan WJ, Frier BM, Steel JM, Duncan LJ. Diabetic lipohypertrophy delays insulin absorption. Diabetes Care. 1984 Sep-Oct;7(5):479-80. doi: 10.2337/diacare.7.5.479. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Levels	The euglycemic clamp technique will be used. Insulin levels will be analyzed by Eliza assay	2 months