Pre-diabetesNCT06188481
Efficacy of Whole-body Electromyostimulation (WB-EMS) Training in Participants With Pre-diabetes
A study testing whole-body electromyostimulation training, activity tracker and evidence-based lifestyle education program in people with Pre-diabetes, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The goal of this pilot study is to assess the efficacy of the intervention (WB-EMS Training) in a sedentary group of adults with pre-diabetes and to estimate the potential effect sizes. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- whole-body electromyostimulation training, activity tracker and evidence-based lifestyle education program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- 23 Jan 2024to 17 Dec 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- community-dwelling sedentary (<20 min physical activity on <3 days/week) men and women aged 40-65 years without Diabetes Type 2
- elevated HbA1c levels (5.7%-6.4%),
- not functionally impaired (Short Physical Performance Battery (SPPB) ≥10)
- signed informed consent
- consent to use the WB-EMS and activity tracker
Who cannot join
- high-grade arrhythmia/VHF/SM carriers, heart failure >NYHA2, nephropathy (GFR<60),
- cognitive impairment
- Diabetes Type 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Whole-body Electromyostimulation (WB-EMS) Training on Glycemic Control in People With Prediabetes: a Randomized Controlled Pilot-study
The goal of this pilot study is to assess the efficacy of the intervention (WB-EMS Training) in a sedentary group of adults with pre-diabetes and to estimate the potential effect sizes.
The main goals and questions it aims to answer are:
- Efficacy WB-EMS training in sedentary adults with pre-diabetes,
- Has WB-EMS training positive effects on HbA1c and other biomarkers?
Researchers will compare the intervention group with two control groups to see if WB-EMS training has effects on pre-diabetes.
Read the detailed description
The study is planned as a randomized controlled pilot study. The intervention phase duration is set to 16 weeks. Prior to the study start, all subjects will be screened for their eligibility according to defined inclusion and exclusion criteria.
Sixty eligible sedentary individuals with pre-diabetes between the ages of 40 and 65 years will be randomised to one intervention group (n=20) and two control groups (n=20 each).
The main exercise intervention will be conducted via WB-EMS using a medical device approved system (miha bodytec®, Type II, Gersthofen, Germany). Participants in the intervention and one control group will receive an activity tracker (vivosmart 5, Garmin) to measure daily steps during the 16-week intervention phase. All study groups will further receive an evidence-based lifestyle education programme (6 x 20 minutes for 3 months), which provides education, information, and advice to prevent disease progression and improve quality of life and mobility.
During the baseline visit and after 16 weeks endpoint measurements incl. blood biomarkers, cardiometabolic and body composition parameters will be assessed. The intervention group will additionally attend a follow-up visit after 32 weeks and the parameters will be assessed again.
- Conditions
- Pre-diabetes
- Being tested
- whole-body electromyostimulation training, activity tracker, evidence-based lifestyle education program
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole-body electromyostimulation trainingOther
The duration of the intervention is 16 weeks, the training frequency is 1.5 times a week and the exercise program consists of 20 minutes.
activity trackerOther
Participants wear the activity tracker on their wrist for the entire 16-week study period.
evidence-based lifestyle education programOther
Participants receive an evidence-based lifestyle education programme (6 x 20 minutes for the period of 3 month).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group with WB-EMS Training | Other | The Intervention group receives 1.5 times a week WB-EMS training, wears an activity tracker for 16 weeks and completes 6 sessions of an evidence-based lifestyle education program. Receives: Other: whole-body electromyostimulation training; Other: activity tracker; Other: evidence-based lifestyle education program |
| Control group with activity tracker and evidence-based lifestyle education program | Other | The control group wears an activity tracker for 16 weeks and completes 6 sessions of an evidence-based lifestyle education program. Receives: Other: activity tracker; Other: evidence-based lifestyle education program |
| Control group with evidence-based lifestyle education program | Other | The control group completes 6 sessions of an evidence-based lifestyle education program. Receives: Other: evidence-based lifestyle education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c in %
Assessed via blood sample with finger stick technique
Measured: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Secondary outcomes (7)
Change from baseline in lipid profile in mg/dL
Assessed via blood sample with finger stick technique. Includes LDL-cholesterol, HDL-cholesterol and triglycerides
Measured: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in waist circumference in cm
Assessed with a measure tape in the centre between the iliac crest and the lower edge of the last palpable rib
Measured: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in body composition
Lean body mass and total body fat in kg will be assessed with bioelectrical impedance analysis (BIA)
Measured: Baseline, after 16 weeks of intervention and after follow-up 32 weeks (only intervention group)
Change from baseline in depressive symptoms
Standardized and validated questionnaire Patient Health Questionnaire consisting of 9 questions on depressive symptoms (PHQ-9) will be used. PHQ-9 is a self-reported questionnaire and is used to assess for the presence and severity of depressive symptoms. Possible score ranges from 0 (no depression) to 27 (severe depression).
Measured: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in health-related quality of life
Standardized and validated questionnaire WHO Health-Related Quality of Life (WHOQOL-BREF) consisting fo 26 questions on general quality of life will be used. The tool includes four domains: physical health, psychological health, social relationships, and environmental health; it also contains quality fo life and general health items. Each item of the WHOQOL-BREF is scored from 1 to 5 on a 5-point Likert scale. The scores are then transformed linearly to a 0-100-scale. A higher score indicates a higher quality of life.
Measured: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in stress
Standardized and validated questionnaire Perceived Stress Scale consisting of 10 questions about stress (PSS-10) will be used. In each questions, subjects are asked how often they felt a certain way on a 5-point scale from 1 for 'never' to 5 for 'very often'. The PSS score indicates levels of perceived stress, whereby higher scores indicate higher stress levels.
Measured: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in well-being
Standardized and validated questionnaire Secure Flourish Index (SFI) consisting of 12 questions on general well-being will be used. Each of the questions is assessed on a scale of 0 - 10. The SFI score is obtained by summing the scores from the 12 questions and results in a score from 0 - 120.
Measured: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start23 Jan 2024
- Primary completion17 Dec 2025
- Study completion17 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mahdieh Shojaa, University Hospital Tuebingen
- Investigators
- Mahdieh Shojaa, Dr., Principal investigator, University Hospital Tuebingen/ Institute of Health Sciences/ Population-Based Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188481
- Sponsor's protocol ID
- WB-EMS
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoshiai M, Ochiai K, Tamura Y, Tsurumi T, Terashima M, Tamiya H, Maeno E, Mizuguchi S, Tomoe T, Kawabe A, Uema A, Ueno A, Sugiyama T, Horie Y, Sugimura H, Koike R, Yasu T. Effects of whole-body neuromuscular electrical stimulation device on hemodynamics, arrhythmia, and sublingual microcirculation. Heart Vessels. 2021 Jun;36(6):844-852. doi: 10.1007/s00380-020-01755-1. Epub 2021 Feb 6.
PubMed 33547929Watanabe K, Yoshida T, Ishikawa T, Kawade S, Moritani T. Effect of the Combination of Whole-Body Neuromuscular Electrical Stimulation and Voluntary Exercise on Metabolic Responses in Human. Front Physiol. 2019 Mar 20;10:291. doi: 10.3389/fphys.2019.00291. eCollection 2019.
PubMed 30949069Kemmler W, Weissenfels A, Willert S, Shojaa M, von Stengel S, Filipovic A, Kleinoder H, Berger J, Frohlich M. Efficacy and Safety of Low Frequency Whole-Body Electromyostimulation (WB-EMS) to Improve Health-Related Outcomes in Non-athletic Adults. A Systematic Review. Front Physiol. 2018 May 23;9:573. doi: 10.3389/fphys.2018.00573. eCollection 2018.
PubMed 29875684Kemmler W, von Stengel S, Kohl M, Rohleder N, Bertsch T, Sieber CC, Freiberger E, Kob R. Safety of a Combined WB-EMS and High-Protein Diet Intervention in Sarcopenic Obese Elderly Men. Clin Interv Aging. 2020 Jun 24;15:953-967. doi: 10.2147/CIA.S248868. eCollection 2020.
PubMed 32612355Kemmler W, Bebenek M, Engelke K, von Stengel S. Impact of whole-body electromyostimulation on body composition in elderly women at risk for sarcopenia: the Training and ElectroStimulation Trial (TEST-III). Age (Dordr). 2014 Feb;36(1):395-406. doi: 10.1007/s11357-013-9575-2. Epub 2013 Aug 16.
PubMed 23949160Kemmler W, Kohl M, Freiberger E, Sieber C, von Stengel S. Effect of whole-body electromyostimulation and / or protein supplementation on obesity and cardiometabolic risk in older men with sarcopenic obesity: the randomized controlled FranSO trial. BMC Geriatr. 2018 Mar 9;18(1):70. doi: 10.1186/s12877-018-0759-6.
PubMed 29523089Kemmler W, von Stengel S. Whole-body electromyostimulation as a means to impact muscle mass and abdominal body fat in lean, sedentary, older female adults: subanalysis of the TEST-III trial. Clin Interv Aging. 2013;8:1353-64. doi: 10.2147/CIA.S52337. Epub 2013 Oct 7.
PubMed 24130433van Buuren F, Horstkotte D, Mellwig KP, Frund A, Vlachojannis M, Bogunovic N, Dimitriadis Z, Vortherms J, Humphrey R, Niebauer J. Electrical Myostimulation (EMS) Improves Glucose Metabolism and Oxygen Uptake in Type 2 Diabetes Mellitus Patients--Results from the EMS Study. Diabetes Technol Ther. 2015 Jun;17(6):413-9. doi: 10.1089/dia.2014.0315. Epub 2015 Mar 3.
PubMed 25734937Miyamoto T, Fukuda K, Kimura T, Matsubara Y, Tsuda K, Moritani T. Effect of percutaneous electrical muscle stimulation on postprandial hyperglycemia in type 2 diabetes. Diabetes Res Clin Pract. 2012 Jun;96(3):306-12. doi: 10.1016/j.diabres.2012.01.006. Epub 2012 Jan 30.
PubMed 22296854Miyamoto T, Iwakura T, Matsuoka N, Iwamoto M, Takenaka M, Akamatsu Y, Moritani T. Impact of prolonged neuromuscular electrical stimulation on metabolic profile and cognition-related blood parameters in type 2 diabetes: A randomized controlled cross-over trial. Diabetes Res Clin Pract. 2018 Aug;142:37-45. doi: 10.1016/j.diabres.2018.05.032. Epub 2018 May 24.
PubMed 29802953Coughlin SS, Stewart J. Use of Consumer Wearable Devices to Promote Physical Activity: A Review of Health Intervention Studies. J Environ Health Sci. 2016 Nov;2(6):10.15436/2378-6841.16.1123. doi: 10.15436/2378-6841.16.1123. Epub 2016 Nov 30.
PubMed 28428979Leskinen T, Suorsa K, Tuominen M, Pulakka A, Pentti J, Loyttyniemi E, Heinonen I, Vahtera J, Stenholm S. The Effect of Consumer-based Activity Tracker Intervention on Physical Activity among Recent Retirees-An RCT Study. Med Sci Sports Exerc. 2021 Aug 1;53(8):1756-1765. doi: 10.1249/MSS.0000000000002627.
PubMed 34261997Ellingson LD, Lansing JE, DeShaw KJ, Peyer KL, Bai Y, Perez M, Phillips LA, Welk GJ. Evaluating Motivational Interviewing and Habit Formation to Enhance the Effect of Activity Trackers on Healthy Adults' Activity Levels: Randomized Intervention. JMIR Mhealth Uhealth. 2019 Feb 14;7(2):e10988. doi: 10.2196/10988.
PubMed 30762582Shojaa M, Knaub K, Schmitz N, Niess AM, Munz B, Rau S, Feit V, Mphepo W, Dingler R, Kemmler W. Effect of Whole-Body Electromyostimulation Training on Glycemic Control in People With Prediabetes: Protocol for a Pilot Randomized Controlled Trial Study. JMIR Res Protoc. 2025 Jun 24;14:e68761. doi: 10.2196/68761.
PubMed 40554784
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Whole-body Electromyostimulation (WB-EMS) Training on Glycemic Control in People With Prediabetes: a Randomized Controlled Pilot-study
- ClinicalTrials.gov ID
- NCT06188481
- Acronym / sponsor ID
- WB-EMS
- Conditions
- Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 3 Jan 2024 (actual)
- 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 goal of this pilot study is to assess the efficacy of the intervention (WB-EMS Training) in a sedentary group of adults with pre-diabetes and to estimate the potential effect sizes.
The main goals and questions it aims to answer are:
- Efficacy WB-EMS training in sedentary adults with pre-diabetes,
- Has WB-EMS training positive effects on HbA1c and other biomarkers?
Researchers will compare the intervention group with two control groups to see if WB-EMS training has effects on pre-diabetes.
Detailed description
The study is planned as a randomized controlled pilot study. The intervention phase duration is set to 16 weeks. Prior to the study start, all subjects will be screened for their eligibility according to defined inclusion and exclusion criteria.
Sixty eligible sedentary individuals with pre-diabetes between the ages of 40 and 65 years will be randomised to one intervention group (n=20) and two control groups (n=20 each).
The main exercise intervention will be conducted via WB-EMS using a medical device approved system (miha bodytec®, Type II, Gersthofen, Germany). Participants in the intervention and one control group will receive an activity tracker (vivosmart 5, Garmin) to measure daily steps during the 16-week intervention phase. All study groups will further receive an evidence-based lifestyle education programme (6 x 20 minutes for 3 months), which provides education, information, and advice to prevent disease progression and improve quality of life and mobility.
During the baseline visit and after 16 weeks endpoint measurements incl. blood biomarkers, cardiometabolic and body composition parameters will be assessed. The intervention group will additionally attend a follow-up visit after 32 weeks and the parameters will be assessed again.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group with WB-EMS Training | Other | Other: whole-body electromyostimulation training, Other: activity tracker, Other: evidence-based lifestyle education programThe Intervention group receives 1.5 times a week WB-EMS training, wears an activity tracker for 16 weeks and completes 6 sessions of an evidence-based lifestyle education program. |
| Control group with activity tracker and evidence-based lifestyle education program | Other | Other: activity tracker, Other: evidence-based lifestyle education programThe control group wears an activity tracker for 16 weeks and completes 6 sessions of an evidence-based lifestyle education program. |
| Control group with evidence-based lifestyle education program | Other | Other: evidence-based lifestyle education programThe control group completes 6 sessions of an evidence-based lifestyle education program. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- community-dwelling sedentary (<20 min physical activity on <3 days/week) men and women aged 40-65 years without Diabetes Type 2
- elevated HbA1c levels (5.7%-6.4%),
- not functionally impaired (Short Physical Performance Battery (SPPB) ≥10)
- signed informed consent
- consent to use the WB-EMS and activity tracker
Key exclusion criteria (3 listed)
- high-grade arrhythmia/VHF/SM carriers, heart failure >NYHA2, nephropathy (GFR<60),
- cognitive impairment
- Diabetes Type 2
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 |
|---|---|---|
| whole-body electromyostimulation trainingThe duration of the intervention is 16 weeks, the training frequency is 1.5 times a week and the exercise program consists of 20 minutes. | Other | Intervention group with WB-EMS Training |
| activity trackerParticipants wear the activity tracker on their wrist for the entire 16-week study period. | Other | Control group with activity tracker and evidence-based lifestyle education program, Intervention group with WB-EMS Training |
| evidence-based lifestyle education programParticipants receive an evidence-based lifestyle education programme (6 x 20 minutes for the period of 3 month). | Other | Control group with activity tracker and evidence-based lifestyle education program, Control group with evidence-based lifestyle education program, Intervention group with WB-EMS Training |
Primary outcome
Change from baseline in HbA1c in %
Time frame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Assessed via blood sample with finger stick technique
7 secondary outcomes
Change from baseline in lipid profile in mg/dL
Time frame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in waist circumference in cm
Time frame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in body composition
Time frame: Baseline, after 16 weeks of intervention and after follow-up 32 weeks (only intervention group)
Change from baseline in depressive symptoms
Time frame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in health-related quality of life
Time frame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in stress
Time frame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in well-being
Time frame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
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 Dec 2025.
- Background: PubMed 33547929Hoshiai M, Ochiai K, Tamura Y, Tsurumi T, Terashima M, Tamiya H, Maeno E, Mizuguchi S, Tomoe T, Kawabe A, Uema A, Ueno A, Sugiyama T, Horie Y, Sugimura H, Koike R, Yasu T. Effects of whole-body neuromuscular electrical stimulation device on hemodynamics, arrhythmia, and sublingual microcirculation. Heart Vessels. 2021 Jun;36(6):844-852. doi: 10.1007/s00380-020-01755-1. Epub 2021 Feb 6.
- Background: PubMed 30949069Watanabe K, Yoshida T, Ishikawa T, Kawade S, Moritani T. Effect of the Combination of Whole-Body Neuromuscular Electrical Stimulation and Voluntary Exercise on Metabolic Responses in Human. Front Physiol. 2019 Mar 20;10:291. doi: 10.3389/fphys.2019.00291. eCollection 2019.
- Background: PubMed 29875684Kemmler W, Weissenfels A, Willert S, Shojaa M, von Stengel S, Filipovic A, Kleinoder H, Berger J, Frohlich M. Efficacy and Safety of Low Frequency Whole-Body Electromyostimulation (WB-EMS) to Improve Health-Related Outcomes in Non-athletic Adults. A Systematic Review. Front Physiol. 2018 May 23;9:573. doi: 10.3389/fphys.2018.00573. eCollection 2018.
- Background: PubMed 32612355Kemmler W, von Stengel S, Kohl M, Rohleder N, Bertsch T, Sieber CC, Freiberger E, Kob R. Safety of a Combined WB-EMS and High-Protein Diet Intervention in Sarcopenic Obese Elderly Men. Clin Interv Aging. 2020 Jun 24;15:953-967. doi: 10.2147/CIA.S248868. eCollection 2020.
- Background: PubMed 23949160Kemmler W, Bebenek M, Engelke K, von Stengel S. Impact of whole-body electromyostimulation on body composition in elderly women at risk for sarcopenia: the Training and ElectroStimulation Trial (TEST-III). Age (Dordr). 2014 Feb;36(1):395-406. doi: 10.1007/s11357-013-9575-2. Epub 2013 Aug 16.
- Background: PubMed 29523089Kemmler W, Kohl M, Freiberger E, Sieber C, von Stengel S. Effect of whole-body electromyostimulation and / or protein supplementation on obesity and cardiometabolic risk in older men with sarcopenic obesity: the randomized controlled FranSO trial. BMC Geriatr. 2018 Mar 9;18(1):70. doi: 10.1186/s12877-018-0759-6.
- Background: PubMed 24130433Kemmler W, von Stengel S. Whole-body electromyostimulation as a means to impact muscle mass and abdominal body fat in lean, sedentary, older female adults: subanalysis of the TEST-III trial. Clin Interv Aging. 2013;8:1353-64. doi: 10.2147/CIA.S52337. Epub 2013 Oct 7.
- Background: PubMed 25734937van Buuren F, Horstkotte D, Mellwig KP, Frund A, Vlachojannis M, Bogunovic N, Dimitriadis Z, Vortherms J, Humphrey R, Niebauer J. Electrical Myostimulation (EMS) Improves Glucose Metabolism and Oxygen Uptake in Type 2 Diabetes Mellitus Patients--Results from the EMS Study. Diabetes Technol Ther. 2015 Jun;17(6):413-9. doi: 10.1089/dia.2014.0315. Epub 2015 Mar 3.
- Background: PubMed 22296854Miyamoto T, Fukuda K, Kimura T, Matsubara Y, Tsuda K, Moritani T. Effect of percutaneous electrical muscle stimulation on postprandial hyperglycemia in type 2 diabetes. Diabetes Res Clin Pract. 2012 Jun;96(3):306-12. doi: 10.1016/j.diabres.2012.01.006. Epub 2012 Jan 30.
- Background: PubMed 29802953Miyamoto T, Iwakura T, Matsuoka N, Iwamoto M, Takenaka M, Akamatsu Y, Moritani T. Impact of prolonged neuromuscular electrical stimulation on metabolic profile and cognition-related blood parameters in type 2 diabetes: A randomized controlled cross-over trial. Diabetes Res Clin Pract. 2018 Aug;142:37-45. doi: 10.1016/j.diabres.2018.05.032. Epub 2018 May 24.
- Background: PubMed 28428979Coughlin SS, Stewart J. Use of Consumer Wearable Devices to Promote Physical Activity: A Review of Health Intervention Studies. J Environ Health Sci. 2016 Nov;2(6):10.15436/2378-6841.16.1123. doi: 10.15436/2378-6841.16.1123. Epub 2016 Nov 30.
- Background: PubMed 34261997Leskinen T, Suorsa K, Tuominen M, Pulakka A, Pentti J, Loyttyniemi E, Heinonen I, Vahtera J, Stenholm S. The Effect of Consumer-based Activity Tracker Intervention on Physical Activity among Recent Retirees-An RCT Study. Med Sci Sports Exerc. 2021 Aug 1;53(8):1756-1765. doi: 10.1249/MSS.0000000000002627.
- Individual participant dataSharing planned: No
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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.
Mahdieh Shojaa, Dr. principal investigator
University Hospital Tuebingen/ Institute of Health Sciences/ Population-Based Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole-body electromyostimulation training, activity tracker and evidence-based lifestyle education program in people with Pre-diabetes, run by University Hospital Tuebingen at 1 site in Germany.
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 5 inclusion and 3 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 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Change from baseline in HbA1c in % (time frame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06188481, which also lists 14 linked publications.
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 Dec 2025.