Effects of Heating Massaging Vibrating Vicinity of the Insulin Delivery Site

NCT ID: NCT01307514

Last Updated: 2011-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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DIABETES

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah Medical Organization

Locations

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Hadassah Medical Organization,

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Itamar Raz, MD

Role: CONTACT

00-972-2-6778021

Arik Tzukert, DMD

Role: CONTACT

00 972 2 6776095

Other Identifiers

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0417-08-HMO

Identifier Type: -

Identifier Source: org_study_id

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