Effects of Heating Massaging Vibrating Vicinity of the Insulin Delivery Site

Protocol for Evaluation of the Effects of Heating Massaging Vibrating or Application of Topical Agent on the Vicinity of the Insulin Delivery Site

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01307514

Enrollment

100

Registered

2011-03-03

Start date

2008-11-30

Completion date

Unknown

Last updated

2011-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DIABETES

Keywords

DIABETES, PHARMACOKINETICS, PHARMACODYNAMICS, INSULIN

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

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

Countries

Israel

Contacts

Primary ContactItamar Raz, MD

ntv502@netvision.co.il00-972-2-6778021

Backup ContactArik Tzukert, DMD

arik@hadassah.org.il00 972 2 6776095

Outcome results