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

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ClinicalTrials.gov Identifier: NCT03229850
Recruitment Status : Suspended (Study was suspended due to current COVID 19 research curtailment)
First Posted : July 26, 2017
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Graydon Meneilly, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Lipohypertrophy Drug: Insulin lispro Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
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.
Primary Purpose: Treatment
Official Title: Dynamics of Insulin Absorption in Subclinical Lipohypertrophy Using the Euglycemic Clamp Technique
Estimated Study Start Date : February 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Subclinical Lipohypertrophy
Insulin lispro will be injected in the abdomen into an area of subclinical lipohypertrophy.
Drug: Insulin lispro
Insulin lispro will be injected into the abdomen into an area of subclinical lipohypertrophy or an area with no subclinical lipohypertrophy

No Subclinical Lipohypertrophy
Insulin lispro will be injected in the abdomen into an area where there is no subclinical lipohypertrophy.
Drug: Insulin lispro
Insulin lispro will be injected into the abdomen into an area of subclinical lipohypertrophy or an area with no subclinical lipohypertrophy




Primary Outcome Measures :
  1. Insulin Levels [ Time Frame: 2 months ]
    The euglycemic clamp technique will be used. Insulin levels will be analyzed by Eliza assay



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229850


Locations
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Canada, British Columbia
University of British Columbia - Gerontology Research Lab
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
Graydon Meneilly
Investigators
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Principal Investigator: Graydon Meneilly, MD University of British Columbia
Publications:

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Responsible Party: Graydon Meneilly, Professor, UBC Department of Medicine, University of British Columbia
ClinicalTrials.gov Identifier: NCT03229850    
Other Study ID Numbers: H17-01270
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Graydon Meneilly, University of British Columbia:
Diabetes
Insulin
Lipohypertrophy
Euglycemic Clamp
Additional relevant MeSH terms:
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Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs