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Effects of Heating Massaging Vibrating Vicinity of the Insulin Delivery Site

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2008 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01307514
First Posted: March 3, 2011
Last Update Posted: March 3, 2011
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.
Information provided by:
Hadassah Medical Organization
  Purpose
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
DIABETES

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 100
Study Start Date: November 2008
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The participants will be patients with insulin dependent diabetes using standard insulin injections or continuous insulin infusion pumps.
Criteria

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
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): NCT01307514


Contacts
Contact: Itamar Raz, MD 00-972-2-6778021 ntv502@netvision.co.il
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il

Locations
Israel
Hadassah Medical Organization, Active, not recruiting
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Responsible Party: Prof. Raz, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01307514     History of Changes
Other Study ID Numbers: 0417-08-HMO
First Submitted: October 2, 2008
First Posted: March 3, 2011
Last Update Posted: March 3, 2011
Last Verified: September 2008

Keywords provided by Hadassah Medical Organization:
DIABETES
PHARMACOKINETICS
PHARMACODYNAMICS
INSULIN

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs