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Optimizing Insulin Absorption and Insulin Injection Technique in Older Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01213901
First received: September 29, 2010
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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 Intervention
Diabetes
Procedure: Lispro insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Optimizing Insulin Absorption and Insulin Injection Technique in Older Adults

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Anatomic site, abdomen versus deltoid, that offers the most consistent(superior) absorption of insulin [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Injection technique which allows the most comfortable method of inserting the needle subcutaneously [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2010
Study Completion Date: March 2014
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01213901     History of Changes
Other Study ID Numbers: H10-00462
Study First Received: September 29, 2010
Last Updated: March 12, 2014
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on November 25, 2014