NCT02293135

Brief Summary

The action of one Stendo pulsating suit session will be evaluated on 16 type 2 diabetic patients referred on the diabetic consultations. The effects of one Stendo pulsating suit session system will be assessed on the peripheral cutaneous microcirculation and on endothelial functions

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 18, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 22, 2015

Status Verified

November 1, 2014

Enrollment Period

7 months

First QC Date

November 7, 2014

Last Update Submit

May 21, 2015

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes ; endothelium stimulation

Outcome Measures

Primary Outcomes (1)

  • Peripheral microcirculation measured using Laser Doppler flowmetry

    Change in % of the peripheral cutaneous microcirculation using laser Doppler flowmetry after one Stendo pulsating suit session

    30 minutes after the end of the Stendo session

Secondary Outcomes (4)

  • Arterial stiffness

    10 minutes after the end of Stendo session

  • Heart Rate Variability (HRV)

    15 minutes after the end of Stendo session

  • Endothelium-dependant microvascular flow after local acetylcholine iontophoresis

    35 minutes after the end of Stendo session

  • Reactive Hyperemia Index (RHI)

    45 minutes after the end of Stendo session

Study Arms (2)

Group 1

EXPERIMENTAL

Verum Stendo session on V1 and Phantom Stendo session on V2

Device: Verum Stendo session on V1 and Phantom Stendo session on V2

Group 2

EXPERIMENTAL

Phantom Stendo session on V1 and Verum Stendo session on V2

Device: Phantom Stendo session on V1 and Verum Stendo session on V2

Interventions

Verum Stendo session on V1 and Phantom Stendo session on V2DEVICE

On the firt V1 visit, the patient will receive the verum Stendo session ; then on V2 visit ((V1 + 13 days +/- 2), the patient will receive the verum Stendo session On the firt visit, V1 the patient will have a phantom Stendo session (no pressure will be applied)

Group 1
Phantom Stendo session on V1 and Verum Stendo session on V2DEVICE

On the firt V1 visit, the patient will have a phantom Stendo session (no pressure will be applied) ; then on V2 visit ((V1 + 13 dayx +/- 2), the patient will receive the verum Stendo session

Group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetic patient
  • Diagnosis of diabetes \> 1 year
  • HBA1c between 6 and 8,5
  • Treated with oral anti-diabetic, insulin and/or incretins which can be stayed unchanged during the 2-week study

You may not qualify if:

  • Type 1 diabetic Patient
  • Antecedent of cardiomyopathy, cardiac ischemia or valvulopathy
  • Severe kidney failure
  • Non controlled hypertension (\> 160/100mm Hg)
  • Cardiac arrhythmia
  • Severe respiratory failure
  • Patient with an advanced obstructive arterial disease
  • Patient with a recent and progressive deep venous thrombosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Jean Verdier, Service d'Endocrinologie Diabétologie Nutrition

Bondy, 93143, France

RECRUITING

Related Publications (1)

  • Valensi P, Barber-Chamoux N, Rezki A, Lambert C, Pereira B, Duale C, Delmas D, Duclos M. Effects of single and multiple sessions of lower body diastole-synchronized compressions using a pulsating pneumatic suit on endothelium function and metabolic parameters in patients with type 2 diabetes: two controlled cross-over studies. Cardiovasc Diabetol. 2022 Dec 22;21(1):286. doi: 10.1186/s12933-022-01710-6.

    PMID: 36550568DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Paul VALENSI, Professor

    Hôpital Jean Verdier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul VALENSI, Professor

CONTACT

+33 1 48 02 65 97paul.valensi@jvr.aphp.fr

Badreddine MERIOUD, MD

CONTACT

+ 33 148 02 65 99badreddine.merioud@jvr.ap-hop-paris.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2014

First Posted

November 18, 2014

Study Start

November 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 22, 2015

Record last verified: 2014-11

Locations

FR(1)