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Effects of Physical Exercise in Type 2 Diabetics

Primary Purpose

Type 2 Diabetes Mellitus

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical exercise
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Médecine Interne et Nutrition, Hôpital Civil, Hôpitaux universitaires de Strasbourg
  • Service de Physiologie et d'Explorations Fonctionnelles, Nouvel Hôpital Civil, Hôpitaux universitaires de Strasbourg
  • Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

physical exercise

Arm Description

Physical exercise

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 25, 2010
Last Updated
October 4, 2017
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT01095068
Brief Title
Effects of Physical Exercise in Type 2 Diabetics
Official Title
Beneficial Effects of Exercise Training on Physical Capacity in Type 2 Diabetics: Improvement in Skeletal Muscle Energetic Capacity, Endothelial Dysfunction and Glycemic Control
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
physical exercise
Arm Type
Experimental
Arm Description
Physical exercise
Intervention Type
Behavioral
Intervention Name(s)
Physical exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: sedentary adult with type 2 diabetes BMI between 25 and 35 kg/m² Hba1c < 10 % Exclusion Criteria: unstable coronary artery disease advanced peripheral occlusive arterial disease proteinuria > 3 g/d and / or creatinine clearance < 30 ml / mn advanced diabetic neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain PRADIGNAC, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Médecine Interne et Nutrition, Hôpital Civil, Hôpitaux universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Service de Physiologie et d'Explorations Fonctionnelles, Nouvel Hôpital Civil, Hôpitaux universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France

12. IPD Sharing Statement

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Effects of Physical Exercise in Type 2 Diabetics

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