Microvascular Response in Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by University Hospital, Angers.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Alfediam
UNIVALOIRE
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00160927
First received: September 9, 2005
Last updated: March 16, 2007
Last verified: March 2007
  Purpose

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 Intervention
Diabetes Mellitus
Device: local heating
Device: iontophoresis
Drug: actylcholine
Drug: sodium nitroprusside

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Microcirculation cutanée et Vasodilatation Induite Par la Pression Non-Nociceptive Chez Les diabètiques

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Estimated Enrollment: 90
Study Start Date: January 2003
Estimated Study Completion Date: January 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diabetes

Exclusion Criteria:

  • Non diabetic neuropathy
  • Peripheral arterial disease
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160927

Contacts
Contact: Jean Louis Saumet, MD PhD +33 (0) 241.35.36.89
Contact: Pierre Abraham

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

Publications:
ClinicalTrials.gov Identifier: NCT00160927     History of Changes
Other Study ID Numbers: PHRC 02-03
Study First Received: September 9, 2005
Last Updated: March 16, 2007
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 20, 2014