Type 2 Diabetes MellitusNCT01095068
Effects of Physical Exercise in Type 2 Diabetics
A study testing Physical exercise in people with Type 2 Diabetes Mellitus, run by University Hospital, Strasbourg, France at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2010to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sedentary adult with type 2 diabetes
- BMI between 25 and 35 kg/m²
- Hba1c < 10 %
Who cannot join
- unstable coronary artery disease
- advanced peripheral occlusive arterial disease
- proteinuria > 3 g/d and / or creatinine clearance < 30 ml / mn
- advanced diabetic neuropathy
Trial locations and contacts
3 sites in 1 country.
France3 sites
Médecine Interne et Nutrition, Hôpital Civil, Hôpitaux universitaires de Strasbourg
Strasbourg, 67091
Service de Physiologie et d'Explorations Fonctionnelles, Nouvel Hôpital Civil, Hôpitaux universitaires de Strasbourg
Strasbourg, 67091
Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg
Strasbourg, 67098
About this study
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
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Physical exercise
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| physical exercise | Experimental | Physical exercise Receives: Behavioral: Physical exercise |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain PRADIGNAC, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095068
- Sponsor's protocol ID
- 3661
- Status last verified
- Sep 2017
- First submitted
- 25 Mar 2010
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01095068
- Acronym / sponsor ID
- 3661
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 29 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| physical exercise | Experimental | Behavioral: Physical exercisePhysical exercise |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- sedentary adult with type 2 diabetes
- BMI between 25 and 35 kg/m²
- Hba1c < 10 %
Key exclusion criteria (4 listed)
- unstable coronary artery disease
- advanced peripheral occlusive arterial disease
- proteinuria > 3 g/d and / or creatinine clearance < 30 ml / mn
- advanced diabetic neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exercise | Behavioural | physical exercise |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain PRADIGNAC, MD principal investigator
Hôpitaux Universitaires de Strasbourg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise in people with Type 2 Diabetes Mellitus, run by University Hospital, Strasbourg, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.