ClinicalTrials.gov
ClinicalTrials.gov Menu

Optimizing Insulin Absorption and Insulin Injection Technique in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01213901
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Graydon Meneilly, University of British Columbia

Brief Summary:

To determine which anatomic site offers the most consistent (superior) absorption of insulin.

To determine the injection technique which allows the most consistent subcutaneous injection of insulin (to pinch or to spread).

Hypothesis:

Based on age-related changes in the amount of subcutaneous fat we anticipate that the absorption of insulin from various anatomical sites will differ.

Justification:

To date health care professionals have extrapolated data obtained from younger adults and applied the results to the elderly.

Objectives:

To determine the rate of insulin absorption from different anatomic sites in diabetic patients over the age of 70.

To determine the best practice for subcutaneous injection in older adults.

Research Method:

Measurement of serial glucose and insulin levels using 360 minute euglycemic clamp studies.

Statistical Analysis:

Paired t test, repeated measures ANOVA


Condition or disease Intervention/treatment Phase
Diabetes Procedure: Lispro insulin Not Applicable

Detailed Description:

The study will consist of 5 visits to the UBC VITALiTY Research Centre. At the screening visit subjects will have the following information collected: height, weight, blood pressure, heart rate, BMI, medical history and concommitant medications. Approximately 15cc of blood will be drawn and analyzed for A1C, CBC with platelets, AST, ALT, alk phos, BUN, creatinine, fasting blood sugar.

The subjects will undergo 4 euglycemic clamp studies at least 30 days apart in random order. During one study subjects will receive the insulin injection in the abdomen using the pinch technique. In another study the subjects will receive the insulin injection using the spread technique. During a third study the subjects will receive the insulin injection in the deltiod area using the pinch technique. During a fourth study the subjects will receive the insulin injection in the deltoid using the spread technique. Subjects will be randomly assigned to the studies. After each injection the subject will complete a questionnaire to rate comfort of the injection.

Subjects will report to the Research Centre at 0700 having fasted since midnight the night before. An intravenous line with normal saline will be placed in one hand to facilitate blood drawing. This hand will be placed in a heated box. A second intravenous will be inserted in the arm for the infusion of glucose.

Prior to subcutaneous insulin injection, blood samples will be collected at -30, -15, and 0 minutes. At time 0 the subcutaneous injection of lispro insulin (0.1 u/kg)will be administered and the glucose infusion will be started. Glucose levels will be measured at the bedside every 5 min and insulin levels every 15 min from 0-360 min. Glucose infusion will be adjusted to maintain glucose levels at a constant level for the duration of the study, using the glucose clamp protocol.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Optimizing Insulin Absorption and Insulin Injection Technique in Older Adults
Study Start Date : September 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1

Each patient will receive 2 insulin injections in the abdomen: Once using a pinch method and once using a spread method.

Injections will be given in a random order and the technician will be blinded to the injection.

Each patient will evaluate the comfort of the injection by completing a visual analog scale.

Procedure: Lispro insulin
Each patient will receive 2 insulin injections in the abdomen: Once using a pinch method and once using a spread method.



Primary Outcome Measures :
  1. Anatomic site, abdomen versus deltoid, that offers the most consistent(superior) absorption of insulin

Secondary Outcome Measures :
  1. Injection technique which allows the most comfortable method of inserting the needle subcutaneously


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female over the age of 70
  • Type 2 diabetes
  • Insulin naive - never have taken insulin with the exception of a short course during a hospitalization or illness
  • A1C between .065-.085
  • BMI between 25 and 35

Exclusion Criteria:

  • hemoglobin below 130g/L (males) and below 120g/L (females)
  • taking medications that are known to interfere with glucose metabolism: systemic corticosteroids, non selective beta blockers
  • Impaired liver function as shown by but not limited to AST and/or ALT > 2 times the upper limit of normal
  • impaired renal function as shown by but not limited to serum creatinine > 133micromoles/L (males) and 124 micromoles/L (female)
  • participation in another clinical trial within the past 30 days

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): NCT01213901


Locations
Canada, British Columbia
Vitality Research Centre - Vancouver General Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Study Director: Gale Tedder Vancouver Coastal Health Research Institute
Study Director: Chris Lockhart Vancouver Coastal Health Research Institute
Study Director: Lee Ann Trimble Vancouver Coastal Health Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Graydon Meneilly, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01213901     History of Changes
Other Study ID Numbers: H10-00462
First Posted: October 4, 2010    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Keywords provided by Graydon Meneilly, University of British Columbia:
Insulin absorption
Insulin injection technique

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs