Microvascular Response in Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00160927
Recruitment Status : Unknown
Verified March 2007 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : March 19, 2007
Information provided by:
University Hospital, Angers

Brief Summary:
Vascular and neurological mechanisms are both likely to be involved in foot ulcer. We recently reported on the hand an original transient pressure-induced vasodilation (PIV) during a 5 mmHg/min increase of pressure strain using laser Doppler flowmetry. This physiological response to non noxious external local pressure strain is a widely protective cutaneous mechanism. The impairment of PIV in diabetic subjects may be relevant to the high prevalence of foot ulcer that occurs in these individuals. The aim of the project is to analyse the different physiopathological processes involved in PIV impairment in diabetic subjects as compared to matched controls.

Condition or disease Intervention/treatment
Diabetes Mellitus Device: local heating Device: iontophoresis Drug: actylcholine Drug: sodium nitroprusside

Detailed Description:
The whole study is a prospective observational study of diabetic type 1 and type 2 subjects focusing on the various physical, physiopathological or pharmacological mechanisms that may interfere with the normal response of the cutaneous microcirculation.The study is currently conducted under various parallel groups of patients and control subjects matched on age and sexe. Techniques used for the study are only non-invasive investigations such as iontophoresis with laser doppler flowmetry, clinical and paraclinical non-invasive investigation of peripheral neuropathy, ultrasound imaging of peripheral arteries.

Study Type : Observational
Enrollment : 90 participants
Observational Model: Case Control
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Retrospective/Prospective
Official Title: Microcirculation cutanée et Vasodilatation Induite Par la Pression Non-Nociceptive Chez Les diabètiques
Study Start Date : January 2003
Estimated Study Completion Date : January 2008

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Diabetes

Exclusion Criteria:

  • Non diabetic neuropathy
  • Peripheral arterial disease
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00160927

Contact: Jean Louis Saumet, MD PhD +33 (0)
Contact: Pierre Abraham

Centre hospitalier universitaire Recruiting
Angers, France, 49933
Contact: Pierre Abraham, MD, PhD         
Sub-Investigator: Pierre Abraham, MD PhD         
Sponsors and Collaborators
University Hospital, Angers
Principal Investigator: Jean Louis Saumet, MD PhD Centre Hospitalier Universitaire Angers

Publications: Identifier: NCT00160927     History of Changes
Other Study ID Numbers: PHRC 02-03
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: March 19, 2007
Last Verified: March 2007

Keywords provided by University Hospital, Angers:
Laser doppler flowmetry
endothelial function

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Antihypertensive Agents
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action