NCT03847779

Brief Summary

Microcirculatory flow is subject to cyclic changes under the influence of heart rate, respiration, myogenic activity, neurogenic factors and endothelial factors. Microcirculatory oscillations (vasomotion) contribute significantly to tissue perfusion. Vasomotion analysis allowed to discriminate normoglycemic subjects, prediabetic subjects and diabetic subjects. Furthermore, changes in vasomotion can precede the emergence of global signs of microangiopathy complications in type 2 diabetes. In fact, few studies reported impaired vasomotion in type 2 diabetes with peripheral neuropathy. Vasomotion analysis after vasodilator (6-min walking test and hyperthermia) and after vasoconstrictor (foot lowering) stimulus could be an effective diagnostic tool to sharpen the diagnostic. Objectives and Methodology: to study vasomotion at baseline and after exercise, hyperthermia and foot lowering within 3 groups of patients: diabetic without peripheral neuropathy, diabetic with subclinical peripheral neuropathy and diabetic with peripheral neuropathy and one group of sex- age- and body mass index-matched healthy control subjects. All the subjects will benefit from a clinical, anthropometric, level of physical activity and biological evaluations. Type 2 diabetes participants will benefit from neuropathy evaluation. In addition, cutaneous microcirculation (perfusion and vasomotion) by means of Laser Doppler Flowmetry and Laser Speckle Imaging will be recorded at rest and after different stimuli (exercise, hyperthermia and foot lowering).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

January 28, 2019

Last Update Submit

November 12, 2020

Conditions

Diabetic Neuropathy PeripheralSmall Vessel Disease of Diabetes MellitusVasodilationVasoconstriction

Keywords

vasomotion

Outcome Measures

Primary Outcomes (1)

  • Changes in average spectral amplitude of the entire frequency range between baseline and after stimulus

    Spectral analysis by wavelet analysis

    Cutaneous blood flow will be recorded during 20 minutes at rest, 10 minutes after foot lowering, 15 minutes after exercise and 20 minutes during hyperthermia

Study Arms (3)

Non-neuropathy

EXPERIMENTAL

Type 2 diabetic without neuropathy: * Negative findings on Semmes-Weinstein monofilament * Neuropathy symptom score (NSS) \<3 * Negative findings on Nerve Check and Diabetic Peripheral Neuropathy check. Interventions by means of Laser Doppler Flowmetry and Laser Speckle Imaging: * "rest" cutaneous microcirculation (perfusion and vasomotion) * "Exercise" cutaneous microcirculation (perfusion and vasomotion) * "Foot lowering" cutaneous microcirculation (perfusion and vasomotion) * "Hyperthermia" cutaneous microcirculation (perfusion and vasomotion) * blood sampling * heart rate variability at rest * pedometer during 4 days * international Physical Activity Questionary * Qualify of Life questionary (EQVOD)

Other: "Rest"Other: "Exercise"Other: "Foot lowering"Other: "Hyperthermia"

Neuropathy

EXPERIMENTAL

Type 2 diabetic with neuropathy * Positive findings on Semmes-Weinstein monofilament * Neuropathy symptom score (NSS) \>3 * Positive findings on Nerve Check and Diabetic Peripheral Neuropathy check. Interventions by means of Laser Doppler Flowmetry and Laser Speckle Imaging: * "rest" cutaneous microcirculation (perfusion and vasomotion) * "Exercise" cutaneous microcirculation (perfusion and vasomotion) * "Foot lowering" cutaneous microcirculation (perfusion and vasomotion) * "Hyperthermia" cutaneous microcirculation (perfusion and vasomotion) * blood sampling * heart rate variability at rest * pedometer during 4 days * international Physical Activity Questionary * Qualify of Life questionary (EQVOD)

Other: "Rest"Other: "Exercise"Other: "Foot lowering"Other: "Hyperthermia"

Controls

EXPERIMENTAL

matched for age, sexe and BMI with diabetic patients. Interventions by means of Laser Doppler Flowmetry and Laser Speckle Imaging: * "rest" cutaneous microcirculation (perfusion and vasomotion) * "Exercise" cutaneous microcirculation (perfusion and vasomotion) * "Foot lowering" cutaneous microcirculation (perfusion and vasomotion) * "Hyperthermia" cutaneous microcirculation (perfusion and vasomotion) * blood sampling * heart rate variability at rest * international Physical Activity Questionary * Qualify of Life questionary (EQVOD)

Other: "Rest"Other: "Exercise"Other: "Foot lowering"Other: "Hyperthermia"

Interventions

"Rest"OTHER

Cutaneous perfusion and vasomotion assessment at rest in supoine position

ControlsNeuropathyNon-neuropathy
"Exercise"OTHER

Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test

ControlsNeuropathyNon-neuropathy
"Foot lowering"OTHER

Cutaneous perfusion and vasomotion assessment after foot lowering

ControlsNeuropathyNon-neuropathy
"Hyperthermia"OTHER

Cutaneous perfusion and vasomotion assessment during hyperthermia

ControlsNeuropathyNon-neuropathy

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For diabetic patients, HbA1C \>6.5 and diabetes duration \>5years
  • For healthy control no diabetes mellitus, no cardiovascular or renal pathology

You may not qualify if:

  • nondiabetic neuropathy
  • on medication known to affect microcirculation
  • presence of active foot ulcer or wound healing history \<3months
  • inability to walk 6 minutes
  • alcohol consumption of more than 3 units per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Henri Duffaut

Avignon, 84 000, France

Location

Related Publications (1)

  • Reynes C, Beaume JB, Latil-Plat F, Ennaifer H, Rocher L, Antoine-Jonville S, Benamo E, Knapp Y, Vinet A. Concomitant Peripheral Neuropathy and Type 2 Diabetes Impairs Postexercise Cutaneous Perfusion and Flowmotion. J Clin Endocrinol Metab. 2021 Sep 27;106(10):e3979-e3989. doi: 10.1210/clinem/dgab414.

    PMID: 34111245DERIVED

MeSH Terms

Conditions

Diabetic AngiopathiesAneurysm

Interventions

RE1-silencing transcription factorExerciseDiathermy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHyperthermia, InducedTherapeutics

Study Officials

  • Eric Benamo, MD

    Centre Hospitalier Avignon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

February 20, 2019

Study Start

February 4, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)