Microvascular Response in Diabetes Mellitus

NCT ID: NCT00160927

Last Updated: 2007-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2008-01-31

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.

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.

Conditions

Diabetes Mellitus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Interventions

local heating

Intervention Type: DEVICE

iontophoresis

Intervention Type: DEVICE

actylcholine

Intervention Type: DRUG

sodium nitroprusside

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diabetes

Exclusion Criteria

• Non diabetic neuropathy
• Peripheral arterial disease
• pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alfediam

OTHER

Sponsor Role: collaborator

UNIVALOIRE

UNKNOWN

Sponsor Role: collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Jean Louis Saumet, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Angers

Locations

Centre hospitalier universitaire

Angers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jean Louis Saumet, MD PhD

Role: CONTACT

+33 (0) 241.35.36.89

Pierre Abraham

Role: CONTACT

Facility Contacts

Pierre Abraham, MD, PhD

Role: primary

References

Koitka A, Legrand-Fernandez MS, Abraham P, Fizanne L, Fromy B, Sigaudo-Roussel D, Saumet JL. Low skin temperature impairs the cutaneous vasodilator response to local progressive pressure strain. Microvasc Res. 2004 Mar;67(2):203-6. doi: 10.1016/j.mvr.2003.12.001.

Reference Type: BACKGROUND

PMID: 15020212 (View on PubMed)

Koitka A, Abraham P, Bouhanick B, Sigaudo-Roussel D, Demiot C, Saumet JL. Impaired pressure-induced vasodilation at the foot in young adults with type 1 diabetes. Diabetes. 2004 Mar;53(3):721-5. doi: 10.2337/diabetes.53.3.721.

Reference Type: BACKGROUND

PMID: 14988257 (View on PubMed)

Other Identifiers

PHRC 02-03

Identifier Type: -

Identifier Source: org_study_id