Type 2 Diabetes MellitusCONTRADIANCT03278704
Concurrent Training in Type 2 Diabetes
A study testing RE only and RE + HIIT in people with Type 2 Diabetes Mellitus, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
It is recommended that individuals perform a combination of resistance exercise (RE) and endurance exercise. Lack of time is often cited as a reason for being unable to meet current exercise guidelines. Therefore, combining both forms in one session may be beneficial. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- RE only and RE + HIIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Dec 2017to 12 Jul 2018
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male sex
- White British/European
- Aged between 40 and 65 years at the time of screening
- Have a body mass index (BMI; body weight/height in m2) between 27 and 40 kg/m2
- Sedentary/untrained for at least 1 year (based on physical activity self-reports of fewer than two sessions of structured exercise per week last <30 min)
- T2DM (American Diabetes Association 2014) for more than 1 year
- Central obesity (defined as waist circumference ≥94 cm for males)
Who cannot join
- Currently involved in research or have recently (<6 months) been involved in any research prior to recruitment
- Any condition limiting or contraindicating physical activity; including diabetic peripheral neuropathy, and coronary or peripheral artery disease
- Previous myocardial infarction, previous or current angina, shortness of breath, or other symptoms suggestive of heart failure
- Insulin medication
- HbA1c more than 75 mmol/mol (9%)
- Uncontrollable hypertension: systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg
Show all 9Show fewer
- Not weight stable for the last three months
- Smokers (within the last 12 months)
- Anticoagulant medication, such as warfarin or newer anticoagulant drugs. If participants are on aspirin medication, this would need to be stopped for 3 days prior to and during the day of any biopsy visit unless contraindicated (in which case participants would be excluded).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham
Birmingham, B15 2TT
About this study
Official title: Effects of Concurrent Resistance Exercise and High-intensity Interval Exercise Training on Skeletal Muscle Adaptations in Individuals With Type 2 Diabetes Mellitus
It is recommended that individuals perform a combination of resistance exercise (RE) and endurance exercise. Lack of time is often cited as a reason for being unable to meet current exercise guidelines. Therefore, combining both forms in one session may be beneficial. However, research continues to elucidate whether interference of adaptive outcomes occurs when RE and endurance exercise are performed concurrently. A proposed interference effect suggests that concurrent training may dampen RE-induced adaptations (e.g., muscle strength and growth) compared to RE only.
The propose of this investigation is to determine the effects of concurrent RE and high-intensity interval training (HIIT), compared to RE only, on muscle health and cardiovascular risk in sedentary, middle-aged (40-65 years) who are overweight/obese with type 2 diabetes mellitus (T2DM). The investigators will measure the effects on muscle strength, muscle growth, cardiovascular fitness, glycaemic control and markers of cardiovascular risk before and after an 8-week training program. Data will be obtained through the analysis of skeletal muscle samples, blood samples, magnetic resonance imaging, questionnaires and exercise performance tests.It is hypothesized that concurrent RE + HIIT will amplify the exercise-induced muscle growth response, which will result in greater satellite cell content, compared to RE alone. As a result, this will lead to greater skeletal muscle mass and strength after RE + HIIT compared to RE in isolation.
A finding that concurrent resistance training and HIIT does not impede muscle adaptations could offer future strategies to minimize exercise time commitment whilst still maximizing the physiological benefits of both resistance and endurance exercise through a single training session. This may therefore provide an effective exercise strategy in the prevention and/or treatment of T2DM.
Read the detailed description
Data analysis will be performed using IBM SPSS statistical software (IBM Corp., Armonk, New York, USA). All data will be checked for normality and appropriate log transformations applied prior to analysis of variance (ANOVA) for primary and secondary outcomes. Satellite cell content will be compared using a two-way, mixed-model ANOVA with one within (2 levels; pre- and post-training) and one between factor (2 level; exercise group) with significance set at P < 0.05.
Based on a mixed ANOVA with between- and within-participant factors, and previously published data (Babcock et al. 2012), a sample size of 24 participants (12 per group) will provide a power of 84%. This sample size will allow detection of a mean change in satellite cell content of 2.35, assuming standard deviations of the change from pre- to post-training as 2.266 and 1.331 in the two exercise groups. Sample size calculation was performed with an alpha error of 0.05. SamplePower 2.0 (SPSS Inc., Chicago, Illinois, USA) software was used to determine sample size.
This study will combine data collected at the University of Birmingham with previously collected data from an identical study design performed by a co-investigator (Dr Pugh) in Rome, Italy. The previous study has collected data from 10 participants across both exercise groups (RE, N = 7; RE + HIIT, N = 3). Therefore, it is necessary for the present study to recruit a further 14 participants (RE, N = 5, RE + HIIT, N = 9) in order to achieve a sample size of 24 participants (12 per group). However, based on an assumption of a 25% drop-out rate, the total minimal sample necessary will be 19 participants (RE, N = 7; RE + HIIT, N = 12).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- RE only, RE + HIIT
- Keywords
- Concurrent training, Type 2 Diabetes Mellitus, Resistance exercise, High-Intensity Interval Training (HIIT), Muscle hypertrophy, Interference effect
- 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.
RE onlyOther
8 weeks of supervised training. Three times weekly with no more than two non-consecutive days without exercise.
RE + HIITOther
8 weeks of supervised training. Three times weekly with no more than two non-consecutive days without exercise. Concurrent training: RE followed by HIIT within the same session.
| Study group | Role | What they receive |
|---|---|---|
| RE training only | Other | RE only - Progressive resistance exercise training only (leg extension, leg step up, chest press and pull down). Receives: Other: RE only |
| Concurrent RE + HIIT | Experimental | RE + HIIT - Progressive resistance exercise training (leg extension, leg step up, chest press and pull down) followed by HIIT (10 x 1 min at 90% heart rate maximum). Receives: Other: RE + HIIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fibre-type specific satellite cell content
Assessed using immunofluorescence microscopy (Pax7-positive cells)
Measured: Prior to the 8-week training intervention and 72 hours after the last training session
Secondary outcomes (9)
Change in muscle-specific gene expression related to growth adaptations
Assessed using reverse-transcription polymerase chain reactions
Measured: Prior to the 8-week training intervention and 72 hours after the last training session
Change in muscle fibre size
Assessed using immunofluorescence microscopy techniques to determine muscle fibre type-specific cross-sectional area
Measured: Prior to the 8-week training intervention and 72 hours after the last training session
Change in muscle size
Assessed using MRI to determine whole and individual muscle group cross-section area and total muscle volume
Measured: Prior to the 8-week training intervention and 48 hours after the last training session
Change in isometric muscle strength
Assessed using a dynamometer
Measured: Prior to the 8-week training intervention and 6 days after the last training session
Change in isokinetic muscle strength
Assessed using a dynamometer
Measured: Prior to the 8-week training intervention and 6 days after the last training session
Change in cardiorespiratory fitness
Assessed using a V̇O2 peak test on a cycle ergometer
Measured: Prior to the 8-week training intervention and 6 days after the last training session
Change in habitual physical activity levels
Assessed using 7-day continuous accelerometry data
Measured: Prior to the 8-week training intervention and 1 week after the last training session
Change in exercise enjoyment
Assessed using validated questionnaires (PACES)
Measured: After the first and last training session
Change in glycaemic control
Assessed using blood analysis
Measured: Prior to the 8-week training intervention and 72 hours after the last training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start6 Dec 2017
- Primary completion12 Jul 2018
- Study completion12 Jul 2018
Why it stopped: Enrollment goal not met in allotted recruitment period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an exploratory randomized controlled trial. Participants will complete a parallel designed study, in which they will be randomly assigned to a resistance exercise (RE) only or concurrent RE and high-intensity interval training (RE + HIIT) group.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Loughborough University, Metabolic Fitness Association, Italy, Università degli studi di Roma Foro Italico
- Responsible party
- Sponsor
- Investigators
- Professor M Nimmo, PhD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278704
- Sponsor's protocol ID
- RG_16-218
- Other IDs
- ERN_16-1612, RRK6071
- Acronym
- CONTRADIA
- Status last verified
- Jul 2018
- First submitted
- 4 Sep 2017
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
American Diabetes Association. Standards of medical care in diabetes--2014. Diabetes Care. 2014 Jan;37 Suppl 1:S14-80. doi: 10.2337/dc14-S014. No abstract available.
PubMed 24357209Babcock L, Escano M, D'Lugos A, Todd K, Murach K, Luden N. Concurrent aerobic exercise interferes with the satellite cell response to acute resistance exercise. Am J Physiol Regul Integr Comp Physiol. 2012 Jun 15;302(12):R1458-65. doi: 10.1152/ajpregu.00035.2012. Epub 2012 Apr 4.
PubMed 22492813Orlando G, Pugh J, Faulkner S, Balducci S, Sacchetti M, Pugliese G, Bazzucchi I, Haxhi J, Martinez-Valdes E, Falla D, Manolopoulos K, Nimmo MA. Muscular Adaptations to Concurrent Resistance Training and High-Intensity Interval Training in Adults with Type 2 Diabetes: A Pilot Study. Int J Environ Res Public Health. 2023 Sep 12;20(18):6746. doi: 10.3390/ijerph20186746.
PubMed 37754606
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Concurrent Resistance Exercise and High-intensity Interval Exercise Training on Skeletal Muscle Adaptations in Individuals With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03278704
- Acronym / sponsor ID
- CONTRADIA / RG_16-218
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Concurrent training, Type 2 Diabetes Mellitus, Resistance exercise, High-Intensity Interval Training (HIIT), Muscle hypertrophy, Interference effect
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment goal not met in allotted recruitment period
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Loughborough University, Metabolic Fitness Association, Italy, Università degli studi di Roma Foro Italico
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 12 Sep 2017 (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.
It is recommended that individuals perform a combination of resistance exercise (RE) and endurance exercise. Lack of time is often cited as a reason for being unable to meet current exercise guidelines. Therefore, combining both forms in one session may be beneficial. However, research continues to elucidate whether interference of adaptive outcomes occurs when RE and endurance exercise are performed concurrently. A proposed interference effect suggests that concurrent training may dampen RE-induced adaptations (e.g., muscle strength and growth) compared to RE only.
The propose of this investigation is to determine the effects of concurrent RE and high-intensity interval training (HIIT), compared to RE only, on muscle health and cardiovascular risk in sedentary, middle-aged (40-65 years) who are overweight/obese with type 2 diabetes mellitus (T2DM). The investigators will measure the effects on muscle strength, muscle growth, cardiovascular fitness, glycaemic control and markers of cardiovascular risk before and after an 8-week training program. Data will be obtained through the analysis of skeletal muscle samples, blood samples, magnetic resonance imaging, questionnaires and exercise performance tests.It is hypothesized that concurrent RE + HIIT will amplify the exercise-induced muscle growth response, which will result in greater satellite cell content, compared to RE alone. As a result, this will lead to greater skeletal muscle mass and strength after RE + HIIT compared to RE in isolation.
A finding that concurrent resistance training and HIIT does not impede muscle adaptations could offer future strategies to minimize exercise time commitment whilst still maximizing the physiological benefits of both resistance and endurance exercise through a single training session. This may therefore provide an effective exercise strategy in the prevention and/or treatment of T2DM.
Detailed description
Data analysis will be performed using IBM SPSS statistical software (IBM Corp., Armonk, New York, USA). All data will be checked for normality and appropriate log transformations applied prior to analysis of variance (ANOVA) for primary and secondary outcomes. Satellite cell content will be compared using a two-way, mixed-model ANOVA with one within (2 levels; pre- and post-training) and one between factor (2 level; exercise group) with significance set at P < 0.05.
Based on a mixed ANOVA with between- and within-participant factors, and previously published data (Babcock et al. 2012), a sample size of 24 participants (12 per group) will provide a power of 84%. This sample size will allow detection of a mean change in satellite cell content of 2.35, assuming standard deviations of the change from pre- to post-training as 2.266 and 1.331 in the two exercise groups. Sample size calculation was performed with an alpha error of 0.05. SamplePower 2.0 (SPSS Inc., Chicago, Illinois, USA) software was used to determine sample size.
This study will combine data collected at the University of Birmingham with previously collected data from an identical study design performed by a co-investigator (Dr Pugh) in Rome, Italy. The previous study has collected data from 10 participants across both exercise groups (RE, N = 7; RE + HIIT, N = 3). Therefore, it is necessary for the present study to recruit a further 14 participants (RE, N = 5, RE + HIIT, N = 9) in order to achieve a sample size of 24 participants (12 per group). However, based on an assumption of a 25% drop-out rate, the total minimal sample necessary will be 19 participants (RE, N = 7; RE + HIIT, N = 12).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an exploratory randomized controlled trial. Participants will complete a parallel designed study, in which they will be randomly assigned to a resistance exercise (RE) only or concurrent RE and high-intensity interval training (RE + HIIT) group.
| Arm | Type | Receives |
|---|---|---|
| RE training only | Other | Other: RE onlyRE only - Progressive resistance exercise training only (leg extension, leg step up, chest press and pull down). |
| Concurrent RE + HIIT | Experimental | Other: RE + HIITRE + HIIT - Progressive resistance exercise training (leg extension, leg step up, chest press and pull down) followed by HIIT (10 x 1 min at 90% heart rate maximum). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male sex
- White British/European
- Aged between 40 and 65 years at the time of screening
- Have a body mass index (BMI; body weight/height in m2) between 27 and 40 kg/m2
- Sedentary/untrained for at least 1 year (based on physical activity self-reports of fewer than two sessions of structured exercise per week last <30 min)
Key exclusion criteria (9 listed)
- Currently involved in research or have recently (<6 months) been involved in any research prior to recruitment
- Any condition limiting or contraindicating physical activity; including diabetic peripheral neuropathy, and coronary or peripheral artery disease
- Previous myocardial infarction, previous or current angina, shortness of breath, or other symptoms suggestive of heart failure
- Insulin medication
- HbA1c more than 75 mmol/mol (9%)
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 |
|---|---|---|
| RE only8 weeks of supervised training. Three times weekly with no more than two non-consecutive days without exercise. | Other | RE training only |
| RE + HIIT8 weeks of supervised training. Three times weekly with no more than two non-consecutive days without exercise. Concurrent training: RE followed by HIIT within the same session. | Other | Concurrent RE + HIIT |
Primary outcome
Change in fibre-type specific satellite cell content
Time frame: Prior to the 8-week training intervention and 72 hours after the last training session
Assessed using immunofluorescence microscopy (Pax7-positive cells)
9 secondary outcomes
Change in muscle-specific gene expression related to growth adaptations
Time frame: Prior to the 8-week training intervention and 72 hours after the last training session
Change in muscle fibre size
Time frame: Prior to the 8-week training intervention and 72 hours after the last training session
Change in muscle size
Time frame: Prior to the 8-week training intervention and 48 hours after the last training session
Change in isometric muscle strength
Time frame: Prior to the 8-week training intervention and 6 days after the last training session
Change in isokinetic muscle strength
Time frame: Prior to the 8-week training intervention and 6 days after the last training session
Change in cardiorespiratory fitness
Time frame: Prior to the 8-week training intervention and 6 days after the last training session
Change in habitual physical activity levels
Time frame: Prior to the 8-week training intervention and 1 week after the last training session
Change in exercise enjoyment
Time frame: After the first and last training session
Change in glycaemic control
Time frame: Prior to the 8-week training intervention and 72 hours after the last training session
Results and safety
The study was stopped early (reason given: Enrollment goal not met in allotted recruitment period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Background: PubMed 24357209American Diabetes Association. Standards of medical care in diabetes--2014. Diabetes Care. 2014 Jan;37 Suppl 1:S14-80. doi: 10.2337/dc14-S014. No abstract available.
- Background: PubMed 22492813Babcock L, Escano M, D'Lugos A, Todd K, Murach K, Luden N. Concurrent aerobic exercise interferes with the satellite cell response to acute resistance exercise. Am J Physiol Regul Integr Comp Physiol. 2012 Jun 15;302(12):R1458-65. doi: 10.1152/ajpregu.00035.2012. Epub 2012 Apr 4.
- Derived from this study: PubMed 37754606Orlando G, Pugh J, Faulkner S, Balducci S, Sacchetti M, Pugliese G, Bazzucchi I, Haxhi J, Martinez-Valdes E, Falla D, Manolopoulos K, Nimmo MA. Muscular Adaptations to Concurrent Resistance Training and High-Intensity Interval Training in Adults with Type 2 Diabetes: A Pilot Study. Int J Environ Res Public Health. 2023 Sep 12;20(18):6746. doi: 10.3390/ijerph20186746.
- Individual participant dataSharing planned: Undecided
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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.
Professor M Nimmo, PhD principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RE only and RE + HIIT in people with Type 2 Diabetes Mellitus, run by University of Birmingham at 1 site in United Kingdom.
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 9 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 17 Jul 2018. 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 United Kingdom. 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 (reason given: Enrollment goal not met in allotted recruitment period). 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.
What does the primary outcome measure?
Change in fibre-type specific satellite cell content (time frame: Prior to the 8-week training intervention and 72 hours after the last training session). 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 NCT03278704, which also lists 3 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 17 Jul 2018.