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Effects of Heating Massaging Vibrating Vicinity of the Insulin Delivery Site

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Unknown status
CT.gov ID
NCT01307514
Collaborator
(none)
100
Enrollment
1
Location

Study Details

Study Description

Brief Summary

The aim of this experiment is to test the pharmacodynamics and pharmacokinetics of insulin analogs and their dependence on external and physiological alterations. The investigators plan compare the pharmacodynamics of insulin analog delivery in regular conditions and in the presence of increased perfusion of the delivery site, achieved by way of local warming, movement and topical application of Capsaicin cream. The investigators will also test the effect of local heating and topical application of Capsaicin cream on the post prandial glucose levels following a bolus.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    Protocol for Evaluation of the Effects of Heating Massaging Vibrating or Application of Topical Agent on the Vicinity of the Insulin Delivery Site
    Study Start Date :
    Nov 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 65 Years
      Sexes Eligible for Study:
      Male
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      1. Participant age between 18- 65 years old

      2. Type I or Type II diabetes

      3. HbA1c 6-12%

      4. Does not suffer from sever hypertension, kidney, liver or heart disease

      5. Does not suffer from active Ischemic heart disease

      6. Is willing to sign the consent form

      Exclusion Criteria:

      1. Participants age < 18 or > 65

      2. Pregnancy

      3. Breast feeding women

      4. Un-controlled diabetes, HbA1c values > 12% range

      5. Suffers from active Ischemic heart disease

      6. Alcohol addiction

      7. Is not prepared to signed the informed consent

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Hadassah Medical Organization, Jerusalem Israel

      Sponsors and Collaborators

      • Hadassah Medical Organization

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01307514
      Other Study ID Numbers:
      • 0417-08-HMO
      First Posted:
      Mar 3, 2011
      Last Update Posted:
      Mar 3, 2011
      Last Verified:
      Sep 1, 2008
      Keywords provided by , ,
      DIABETES
      PHARMACOKINETICS
      PHARMACODYNAMICS
      INSULIN

      Study Results

      No Results Posted as of Mar 3, 2011