Effects of Heating Massaging Vibrating Vicinity of the Insulin Delivery Site

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01307514
First received: October 2, 2008
Last updated: March 1, 2011
Last verified: September 2008
  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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
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: 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

No publications provided

Responsible Party: Prof. Raz, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01307514     History of Changes
Other Study ID Numbers: 0417-08-HMO
Study First Received: October 2, 2008
Last Updated: March 1, 2011
Health Authority: Israel: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Hadassah Medical Organization:
DIABETES
PHARMACOKINETICS
PHARMACODYNAMICS
INSULIN

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

ClinicalTrials.gov processed this record on October 01, 2014