Effects of Heating Massaging Vibrating Vicinity of the Insulin Delivery Site

DIABETES Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01307514
• Other study ID #: 0417-08-HMO
• Status: Not yet recruiting
• Phase: N/A
• First received: October 2, 2008
• Last updated: March 1, 2011
• Start date: November 2008

Study information

• Verified date: September 2008
• Source: Hadassah Medical Organization
• Contact: Itamar Raz, MD
• Phone: 00-972-2-6778021
• Email: ntv502[@]netvision.co.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• DIABETES

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization,	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel,