- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01307514
Effects of Heating Massaging Vibrating Vicinity of the Insulin Delivery Site
March 1, 2011 updated by: Hadassah Medical Organization
Protocol for Evaluation of the Effects of Heating Massaging Vibrating or Application of Topical Agent on the Vicinity of the Insulin Delivery Site
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jerusalem, Israel
- Hadassah Medical Organization,
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
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.
Description
Inclusion Criteria:
- Participant age between 18- 65 years old
- Type I or Type II diabetes
- HbA1c 6-12%
- Does not suffer from sever hypertension, kidney, liver or heart disease
- Does not suffer from active Ischemic heart disease
- Is willing to sign the consent form
Exclusion Criteria:
- Participants age < 18 or > 65
- Pregnancy
- Breast feeding women
- Un-controlled diabetes, HbA1c values > 12% range
- Suffers from active Ischemic heart disease
- Alcohol addiction
- Is not prepared to signed the informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Study Registration Dates
First Submitted
October 2, 2008
First Submitted That Met QC Criteria
March 1, 2011
First Posted (Estimate)
March 3, 2011
Study Record Updates
Last Update Posted (Estimate)
March 3, 2011
Last Update Submitted That Met QC Criteria
March 1, 2011
Last Verified
September 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0417-08-HMO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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