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OpenTrials
Completed

NCT Number: NCT01213901

Optimizing Insulin Absorption and Insulin Injection Technique in Older Adults

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

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vitality Research Centre - Vancouver General Hospital

Vancouver, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lispro insulin

Procedure

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

Primary outcomes

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

Secondary outcomes

  1. Injection technique which allows the most comfortable method of inserting the needle subcutaneously

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Oct 4, 2010
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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