NCT01095068

Brief Summary

The aim of this study is to evaluate the improvement in skeletal muscle energetic capacity, endothelial dysfunction and glycemic control induced by physical training in 20 sedentary patients with a type 2 diabetes.The protocol consists in a physical training program with 3 sessions of 30 minutes per week during six consecutive weeks. A skeletal muscle biopsy, a cardiac and humeral artery ultrasounds, a glycemic and tensional holters will be performed before and at the end of the physical training program.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

3 active sites

Status
terminated

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

March 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

October 5, 2017

Status Verified

September 1, 2017

Enrollment Period

4.4 years

First QC Date

March 25, 2010

Last Update Submit

October 4, 2017

Conditions

Type 2 Diabetes Mellitus

Study Arms (1)

physical exercise

EXPERIMENTAL

Physical exercise

Behavioral: Physical exercise

Interventions

Physical exerciseBEHAVIORAL
physical exercise

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sedentary adult with type 2 diabetes
  • BMI between 25 and 35 kg/m²
  • Hba1c \< 10 %

You may not qualify if:

  • unstable coronary artery disease
  • advanced peripheral occlusive arterial disease
  • proteinuria \> 3 g/d and / or creatinine clearance \< 30 ml / mn
  • advanced diabetic neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Médecine Interne et Nutrition, Hôpital Civil, Hôpitaux universitaires de Strasbourg

Strasbourg, 67091, France

Location

Service de Physiologie et d'Explorations Fonctionnelles, Nouvel Hôpital Civil, Hôpitaux universitaires de Strasbourg

Strasbourg, 67091, France

Location

Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alain PRADIGNAC, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2010

First Posted

March 29, 2010

Study Start

March 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

October 5, 2017

Record last verified: 2017-09

Locations

FR(3)