Effects of Heating Massaging Vibrating Vicinity of the Insulin Delivery Site

• Conditions: DIABETES

• Registration Number: NCT01307514
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-09
• Study First Submitted: 2008-10-02
• Study Start: 2008-11
• Study First Submitted QC: 2011-03-01
• Last Update Submitted: 2011-03-01
• Study First Posted: 2011-03-03
• Last Update Posted: 2011-03-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Hadassah Medical Organization,; 🇮🇱 Jerusalem, Israel