Type 2 DiabetesELECTRODIAB2NCT02157480
Effect of Electrostimulation on Glucose Profile of Patients With Type 2 Diabetes
A study testing electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week . and electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week in people with Type 2 Diabetes and Physical Activity, run by University Hospital, Caen at 5 sites in France.
Trial summary
Prevalence of type 2 diabetes (T2D) is increasing worldwide. Lifestyle remains the cornerstone treatment for patients with T2D who are often overweight and sedentary. Physical activity improves glucose metabolism of patients with T2D : increased glucose utilization during acute muscle activity and improved insulin… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes, Physical Activity
- What is being tested?
- electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week . and electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 5 sitesFrance
- Study dates
- Sep 2014to Jul 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes treated with lifestyle, oral hypoglycemic agents and/or GLP-1 agonists.
- HbA1c : 7 to 10%
- low physical activity (Ricci and Gagnon score below 27)
- Insulin-resistance (at least one criteria out three):
- Waist circumference > 80cm in women and > 94cm in men
- Triglycerides > 150 mg/dl
- HDL-c < 50 mg/dl for women, < 40 mg/dl for men
Who cannot join
- type 1 diabetes
- pregnancy
- intense usual physical activity
- pace maker
- seizure
- knee or neuromuscular pathology
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
University Hospital Amiens
Amiens
Clinical Research Center University Hospital Caen
Caen, 14033
University Hospital Lille
Lille
General Hospital Roubaix
Roubaix
CHU Rouen
Rouen, 76000
About this study
Official title: ELECTRODIAB2: Effect of an Outpatient Program of Bi-quadricipital Electrostimulation on Glucose Profile of Sedentary Patients With Type 2 Diabetes.
Prevalence of type 2 diabetes (T2D) is increasing worldwide. Lifestyle remains the cornerstone treatment for patients with T2D who are often overweight and sedentary.
Physical activity improves glucose metabolism of patients with T2D : increased glucose utilization during acute muscle activity and improved insulin sensitivity after regular training. The molecular mechanism underlying the effects of exercise on glucose metabolism involves the glucose transporter GLUT-4 which is regulated by physical activity.
Read more
Several studies and meta-analysis have showed that physical activity reduces HbA1c by 0.6% on average. In addition, other data suggest a decrease in cardiovascular morbidity and mortality through physical activity.
Recent recommendations for T2D management call for the practice of a structured type of endurance 150 minutes per week and muscle building 2 times per week. However, implementation of these recommendations is low, even when integrated into a therapeutic education program. Adherence is often transient and / or partial. In addition, many T2D subjects are unable to initiate a physical activity because of disabling complications or comorbidities or because of a major cardiorespiratory deconditioning.
Neuro-myo electrical stimulation (NMES) is a physical treatment routinely used in functional rehabilitation to improve muscle strength and volume. The metabolic effect of NMES has been little studied. A pilot study conducted by our team on a population of 18 subjects with T2D showed that a week of daily NMES sessions significantly improved insulin sensitivity of about 25% and up to 50 % for good responders. This result contrasted with the low induced energy expenditure by each 20-minute session of bi-quadricipital NMES, suggesting the possibility of a humoral or neural mechanism associated with NMES.
To complete this work, we plan a randomized cross-over trial with 3 periods (6 weeks without NMES (control), 6 weeks with 3 sessions of NMES per week and 6 weeks with 5 sessions of NMES per week) to assess the glucose profile of sedentary T2D subjects during these different periods. We hypothesize that the bi-quadricipital NMES could improve glycemic control in T2D subjects and thus represent an alternative to traditional physical activity.
- Conditions
- Type 2 Diabetes, Physical Activity
- Being tested
- electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week ., electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week
- Keywords
- glucose profile, continuous glucose monitoring, electrostimulation
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week .Device
outpatient biquadricipital electrostimulation 3 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA)
electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per weekDevice
outpatient biquadricipital electrostimulation 5 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA)
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | usual follow-up for 6 weeks |
| electrostimulation 3 days per week | Experimental | 20 minutes ambulatory bi-quadricipital electrostimulation sessions three times per week for 6 weeks Receives: Device: electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week . |
| electrostimulation 5 days per week | Experimental | 20 minutes ambulatory bi-quadricipital electrostimulation sessions five times per week for 6 weeks Receives: Device: electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean CGM glucose from a 6-day CGM recording
Measured: week 0, 6, 13, 20
Secondary outcomes (1)
HbA1c
Measured: week 0, 6, 13, 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2022
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Rouen, Amiens University Hospital, University Hospital, Lille, General Hospital Roubaix
- Responsible party
- Sponsor
- Investigators
- Corinne FOURMY, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157480
- Sponsor's protocol ID
- 2014-A00231-46
- Acronym
- ELECTRODIAB2
- Status last verified
- Jul 2022
- First submitted
- 19 May 2014
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELECTRODIAB2: Effect of an Outpatient Program of Bi-quadricipital Electrostimulation on Glucose Profile of Sedentary Patients With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT02157480
- Acronym / sponsor ID
- ELECTRODIAB2 / 2014-A00231-46
- Conditions
- Type 2 Diabetes, Physical Activity
- Keywords
- glucose profile, continuous glucose monitoring, electrostimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- University Hospital, Rouen, Amiens University Hospital, University Hospital, Lille, General Hospital Roubaix
- Study start
- Sep 2014
- Primary completion
- Jul 2022 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 6 Jun 2014 (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.
Prevalence of type 2 diabetes (T2D) is increasing worldwide. Lifestyle remains the cornerstone treatment for patients with T2D who are often overweight and sedentary.
Physical activity improves glucose metabolism of patients with T2D : increased glucose utilization during acute muscle activity and improved insulin sensitivity after regular training. The molecular mechanism underlying the effects of exercise on glucose metabolism involves the glucose transporter GLUT-4 which is regulated by physical activity.
Several studies and meta-analysis have showed that physical activity reduces HbA1c by 0.6% on average. In addition, other data suggest a decrease in cardiovascular morbidity and mortality through physical activity.
Recent recommendations for T2D management call for the practice of a structured type of endurance 150 minutes per week and muscle building 2 times per week. However, implementation of these recommendations is low, even when integrated into a therapeutic education program. Adherence is often transient and / or partial. In addition, many T2D subjects are unable to initiate a physical activity because of disabling complications or comorbidities or because of a major cardiorespiratory deconditioning.
Neuro-myo electrical stimulation (NMES) is a physical treatment routinely used in functional rehabilitation to improve muscle strength and volume. The metabolic effect of NMES has been little studied. A pilot study conducted by our team on a population of 18 subjects with T2D showed that a week of daily NMES sessions significantly improved insulin sensitivity of about 25% and up to 50 % for good responders. This result contrasted with the low induced energy expenditure by each 20-minute session of bi-quadricipital NMES, suggesting the possibility of a humoral or neural mechanism associated with NMES.
To complete this work, we plan a randomized cross-over trial with 3 periods (6 weeks without NMES (control), 6 weeks with 3 sessions of NMES per week and 6 weeks with 5 sessions of NMES per week) to assess the glucose profile of sedentary T2D subjects during these different periods. We hypothesize that the bi-quadricipital NMES could improve glycemic control in T2D subjects and thus represent an alternative to traditional physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –usual follow-up for 6 weeks |
| electrostimulation 3 days per week | Experimental | Device: electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week .20 minutes ambulatory bi-quadricipital electrostimulation sessions three times per week for 6 weeks |
| electrostimulation 5 days per week | Experimental | Device: electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week20 minutes ambulatory bi-quadricipital electrostimulation sessions five times per week for 6 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Type 2 diabetes treated with lifestyle, oral hypoglycemic agents and/or GLP-1 agonists.
- HbA1c : 7 to 10%
- low physical activity (Ricci and Gagnon score below 27)
- Insulin-resistance (at least one criteria out three):
- Waist circumference > 80cm in women and > 94cm in men
Key exclusion criteria (6 listed)
- type 1 diabetes
- pregnancy
- intense usual physical activity
- pace maker
- seizure
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 |
|---|---|---|
| electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week .outpatient biquadricipital electrostimulation 3 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA) | Device | electrostimulation 3 days per week |
| electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per weekoutpatient biquadricipital electrostimulation 5 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA) | Device | electrostimulation 5 days per week |
Primary outcome
Mean CGM glucose from a 6-day CGM recording
Time frame: week 0, 6, 13, 20
1 secondary outcome
HbA1c
Time frame: week 0, 6, 13, 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
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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.
Corinne FOURMY, MD principal investigator
University Hospital, Caen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week . and electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week in people with Type 2 Diabetes and Physical Activity, run by University Hospital, Caen at 5 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Mean CGM glucose from a 6-day CGM recording (time frame: week 0, 6, 13, 20). It is what the study was designed to measure, not a finding.
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 24 Aug 2022.