An interventional study of NMES and NMES-placebo in Type2 Diabetes Mellitus, sponsored by Hospital de Clinicas de Porto Alegre. Completed at 1 site in Brazil. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2020-08-04.
Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 23 studies in Diabetes Mellitus, Type 2 by Hospital de Clinicas de Porto Alegre — 6 open to participants now, 6 under way, none of them phase 3. Diabetes Mellitus, Type 2 · Hospital de Clinicas de Porto Alegre.
Among the 23 studies in Diabetes Mellitus, Type 2 by Hospital de Clinicas de Porto Alegre, this one is the 15th largest by enrollment, is one of 3 that started in 2017, is one of 21 with no phase, and was the 16th registered.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →6 of the 23 studies in Diabetes Mellitus, Type 2 by Hospital de Clinicas de Porto Alegre are open now, in 1 country. Recruiting first, the newest first:
Hospital de Clinicas de Porto Alegre · Sites in Brazil
Ages 60+
Hospital de Clinicas de Porto Alegre · Sites in Brazil
Ages 18–65
Hospital de Clinicas de Porto Alegre · Sites in Brazil
Hospital de Clinicas de Porto Alegre · Sites in Brazil
Ages 30–80
Hospital de Clinicas de Porto Alegre · Sites in Brazil
Ages 18+
By country, each count listing its studies:
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 205 take healthy volunteers.
This study: 30 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 28 is below the median of 80 across 8,359 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 40 across the 23 interventional studies. Of the 11 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 23 studies in Diabetes Mellitus, Type 2 by Hospital de Clinicas de Porto Alegre, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
In patients with type 2 diabetes mellitus (T2DM) chronic hyperglycemia is the main cause of complications, promoting several micro and macrovascular damages. In order to understand other mechanisms that could have an impact on the development of these diabetic complications, the assessment of glycemic variability have been widely used. Glucose control can be achieved with multiple interventions, including exercise training. Some individuals, however, especially those with autonomic neuropathy, can have exercise intolerance. In this context, physical therapy proposes neuromuscular electrical stimulation (NMES) as a therapeutic that has been applied in research and clinical practice as an alternative to the training of patients who cannot perform conventional exercise. In patients with T2DM, NMES was shown to improve glycemic control and insulin sensitivity, but quality of these trials is poor. In addition, the effects of NMES on glycemic variability of T2DM patients have not yet been reported. The aim of this study is to evaluate the effects of NMES on glucose levels and glucose variability in patients with T2DM.
Patients with T2DM will be recruited from outpatient clinic of the Hospital de Clinicas de Porto Alegre. Patients will be randomized to NMES session, with maximal intensity tolerance by to induce visible contractions or to NMES-placebo, with minimal intensity to provide a sensory stimulus, but insufficient to elicit a tetanic muscular contraction. Subjects will attend to research facility four times. On the first visit clinical, physical examination and autonomic evaluation (Ewing test) will be performed and a blood sample will be collected. On the second visit CGMS will be placed for glycemic variability evaluation. On the third visit NMES or NMES-placebo will be performed in a randomized way. On the fourth visit the CGMS will be removed. Blood pressure and heart rate will be evaluated during the protocol each 5 minutes and oxygenation tissue will be evaluated before, during and immediately after the protocol, through NIRS.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
This study's enrollment of 28 is below the median of 80 across 8,359 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.
Compared within Diabetes Mellitus, Type 2, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes Mellitus. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NMES will be placed at the knee extensors, with maximal intensity tolerance evaluated by to induce visible contractions.
Device: NMES
NMES-placebo will be placed at the knee extensors, with minimal intensity to provide a sensory stimulus, but insufficient to elicit a tetanic muscular contraction.
Device: NMES-placebo
NMES will be placed at the knee extensors. Stimulation frequency will be 20 Hz. Pulse width will be 0.5 milliseconds and the contraction time will be 10 seconds (TON: 10s) with a 5-second rest interval (TOFF: 5s). Total time application will be 60 minutes. Intensity will be adjusted individually, taking into account the patient's ability to promote the full knee extension and comfort during contractions.
NMES-placebo will be placed at the knee extensors. Stimulation frequency will be 20 Hz. Pulse width will be 0.5 milliseconds and the contraction time will be 10 seconds (TON: 10s) with a 5-second rest interval (TOFF: 5s). Total time of application will be 60 minutes. Intensity will be adjusted with minimal intensity, utilized to provide a sensory stimulus, but insufficient to elicit a tetanic muscular contraction.
Glucose levels
Glucose levels will be assessed through continuous glucose monitoring (CGMS)
Time frame: 48 hours
Glucose variability
Glucose variability will be assessed by CGMS 24 hours before, during the protocol and 24 hours after protocol.
Time frame: 48 hours
Blood pressure
Will be evaluated through non-invasive oscillometric device.
Time frame: Each 5 minutes during intervention which will last 60 minutes.
Heart Rate
Will be evaluated through non-invasive oscillometric device.
Time frame: Each 5 minutes during intervention which will last 60 minutes.
Oxygenation tissue
Will be evaluated through near infrared spectroscopy (NIRS).
Time frame: Before, during and immediately after the intervention which will last 60 minutes.
Plan to share: Undecided
Ran from Sep 2017 to primary completion in Mar 2020, 30 months.
Of 2,068 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 30 months is above that.
Counting every sponsor, half of 2,245 studies reached it within 21 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital de Clinicas de Porto Alegre →