Diabetes Mellitus, Type 2NCT02444156
Rowing Away From Diabetes
A study testing Indoor rowing in people with Diabetes Mellitus, Type 2 and Glucose Intolerance, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Primary research question: What is the effect of indoor rowing, under the ideal circumstances of a laboratory setting, on glucose control in adults with impaired glucose control? Secondary research question: Is it possible to develop a full-scale study of the benefits of indoor rowing under the usual circumstances of… Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Glucose Intolerance, Hyperglycemia
- What is being tested?
- Indoor rowing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Oct 2016
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Participant is willing to allow their general practitioner to be informed of any incidental findings.
- Eligible men will be 45 to 65 years of age.
- Eligible women will be 45 to 65 years of age and will be postmenopausal, defined as no menstrual period in the last 12 months.
- Body mass index of 25 to 40 kg·m-2.
- Stable weight, defined as self-reported weight change of less than 5 kg in the last six months.
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- Impaired glucose regulation, defined as impaired fasting glucose (fasting plasma glucose of 5.6 to 6.9 mmol·l-1), or impaired glucose tolerance (two-hour plasma glucose in the 75-g oral glucose tolerance test of 7.8 to 11.0 mmol·l-1), or haemoglobin A1C of 6.0% or greater, or type 2 diabetes (fasting plasma glucose of 7.0 mmol·l-1 or greater on two occasions).
- Volunteers with type 2 diabetes will either be treatment naïve or will have been taking a stable dose of metformin for at least four weeks prior to study entry.
- White European ethnicity. There are ethnic differences in cardiovascular disease risk and prevailing definitions of dyslipidaemia, insulin resistance and diabetes cannot account for these differences (Forouhi et al., Diabetologia, 2006, 49, 2580-8; Tillin et al., Journal of the American College of Cardiology, 2013, 61, 1777-86). Therefore, in order to make valid inferences, the investigators will only include white Europeans on this occasion.
- Little or no participation in exercise: eligible volunteers will not have been exercising two or more times per week for 20 minutes or longer for the last six months.
Who cannot join
- Volunteers with type 2 diabetes will be excluded if they are taking any form of diabetes medication other than metformin.
- Known cardiovascular disease.
- Symptoms of angina.
- Resting systole blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg.
- Statin use.
- Beta-blocker use.
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- Verapamil use.
- Hormone replacement therapy.
- Any smoking in the last year.
- Any absolute contraindication to exercise testing.
- Abnormal exercise test.
- Inability to undertake an exercise programme for any reason.
- Participation in a research study involving an investigational produce in the past 12 weeks.
- Female volunteers who are pregnant, lactating or planning pregnancy during the course of the study. Pregnancy will be discussed during the consent procedure and the investigators will provide those in any doubt with a pregnancy test kit.
- Chronic kidney disease (EGFR of ≤30).
- Any metal implants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Indoor Rowing in Adults With Impaired Glucose Regulation: a Pilot Study
Primary research question: What is the effect of indoor rowing, under the ideal circumstances of a laboratory setting, on glucose control in adults with impaired glucose control?
Secondary research question: Is it possible to develop a full-scale study of the benefits of indoor rowing under the usual circumstances of a community setting?
Read more
Why? It is good practice to conduct a small pilot study before embarking on an expensive full-scale study.
What? Around 150 minutes of aerobic exercise and around 150 minutes of resistance exercise per week are necessary to meet prevailing recommendations for adults with impaired glucose control. Around 120 minutes of indoor rowing per week might be a less time-consuming alternative to prevailing recommendations because indoor rowing involves a combination of aerobic and resistance exercise.
Who? Twenty men and postmenopausal women aged 45-65 years with impaired glucose regulation, such as those with type 2 diabetes. Eligible volunteers will not have smoked in the last year, will not have exercised regularly in the last six months, and will not be taking any form of diabetes medication other than metformin. Eligible volunteers will have stable weight and a body mass index of 25-40.
Where and how? Before and after the exercise intervention, glucose control (postprandial blood glucose concentrations) will be assessed at Leicester Diabetes Centre and cardiac function (MRI) will be assessed at Glenfield Hospital. During the exercise intervention, participants will use an indoor rower three times per week for 12 weeks at Leicester Diabetes Centre. Participants will be taught how to row correctly and the duration and intensity will gradually increase. In order to inform the design of a full-scale trial, recruitment rate will be assessed, adherence will be monitored, and a third party will interview participants to find out if the intervention and assessments are feasible and acceptable.
- Being tested
- Indoor rowing
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indoor rowingOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | All participants will receive usual care, including standard advice about diet and physical activity. In addition to usual care, participants will be asked to take part in a 12-week exercise programme. Participants will use an indoor rower (Concept 2, Model E) three times per week at Leicester Diabetes Centre. Each session will be supervised and the investigators will liaise with the participants to arrange convenient times to exercise, including mornings and evenings. The supervisors will teach the participants how to row correctly. Receives: Other: Indoor rowing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glucose control
Glucose control is indicated by postprandial glucose concentration, which will be assessed using a standardized meal test.
Measured: Changes from baseline (week 0) to post intervention (week 0 versus week 13 and week 0 versus week 14)
Change in Cardiac function
Cardiac function is indicated by diastolic strain rate, which will be assessed using magnetic resonance imaging.
Measured: Changes from baseline (week 0) to post intervention (week 13)
Secondary outcomes (3)
Recruitment rate
Participants will be recruited via general practice databases and the investigators will calculate the proportion of eligible-and-invited individuals who agree to take part in the study.
Measured: Response rate to up to seven months of recruitment
Feasibility and acceptability as assessed by Semi-structured interviews
The interview during the intervention will focus on recruitment literature, screening procedures, baseline assessments, and first impressions of indoor rowing. The interview after the intervention will focus on participants' experiences of indoor rowing, including their likes, dislikes and suggestions. Each interview will last around 30 to 60 minutes and will be led by an independent researcher not involved in the day-to-day conduct of the study. Some questions and topics will be predetermined, but conversations will be allowed to flow freely and change according to the interviewer's discretion.
Measured: Semi-structured interviews will be conducted during (week 5 or 6) and after (week 14) the intervention
Change in Sample size in a full-scale trial
Haemoglobin A1C is a longer-term marker of glucose control and may be an appropriate outcome for a full-scale trial. The investigators wish to use the sample standard deviation from this pilot study in haemoglobin A1C (and, possibly, other variables) to estimate the population standard deviation and, thus, the power of a full-scale trial.
Measured: Changes from baseline (week 0) to post intervention (week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Melanie Davies, MD, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444156
- Sponsor's protocol ID
- 0492
- Status last verified
- May 2015
- First submitted
- 7 May 2015
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indoor Rowing in Adults With Impaired Glucose Regulation: a Pilot Study
- ClinicalTrials.gov ID
- NCT02444156
- Acronym / sponsor ID
- 0492
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- Medtronic, Wellcome Trust
- Study start
- Jun 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 May 2015 (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.
Primary research question: What is the effect of indoor rowing, under the ideal circumstances of a laboratory setting, on glucose control in adults with impaired glucose control?
Secondary research question: Is it possible to develop a full-scale study of the benefits of indoor rowing under the usual circumstances of a community setting?
Why? It is good practice to conduct a small pilot study before embarking on an expensive full-scale study.
What? Around 150 minutes of aerobic exercise and around 150 minutes of resistance exercise per week are necessary to meet prevailing recommendations for adults with impaired glucose control. Around 120 minutes of indoor rowing per week might be a less time-consuming alternative to prevailing recommendations because indoor rowing involves a combination of aerobic and resistance exercise.
Who? Twenty men and postmenopausal women aged 45-65 years with impaired glucose regulation, such as those with type 2 diabetes. Eligible volunteers will not have smoked in the last year, will not have exercised regularly in the last six months, and will not be taking any form of diabetes medication other than metformin. Eligible volunteers will have stable weight and a body mass index of 25-40.
Where and how? Before and after the exercise intervention, glucose control (postprandial blood glucose concentrations) will be assessed at Leicester Diabetes Centre and cardiac function (MRI) will be assessed at Glenfield Hospital. During the exercise intervention, participants will use an indoor rower three times per week for 12 weeks at Leicester Diabetes Centre. Participants will be taught how to row correctly and the duration and intensity will gradually increase. In order to inform the design of a full-scale trial, recruitment rate will be assessed, adherence will be monitored, and a third party will interview participants to find out if the intervention and assessments are feasible and acceptable.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Other: Indoor rowingAll participants will receive usual care, including standard advice about diet and physical activity. In addition to usual care, participants will be asked to take part in a 12-week exercise programme. Participants will use an indoor rower (Concept 2, Model E) three times per week at Leicester Diabetes Centre. Each session will be supervised and the investigators will liaise with the participants to arrange convenient times to exercise, including mornings and evenings. The supervisors will teach the participants how to row correctly. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Participant is willing to allow their general practitioner to be informed of any incidental findings.
- Eligible men will be 45 to 65 years of age.
- Eligible women will be 45 to 65 years of age and will be postmenopausal, defined as no menstrual period in the last 12 months.
- Body mass index of 25 to 40 kg·m-2.
Key exclusion criteria (16 listed)
- Volunteers with type 2 diabetes will be excluded if they are taking any form of diabetes medication other than metformin.
- Known cardiovascular disease.
- Symptoms of angina.
- Resting systole blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg.
- Statin use.
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 |
|---|---|---|
| Indoor rowing | Other | Exercise training |
Primary outcome
Change in Glucose control
Time frame: Changes from baseline (week 0) to post intervention (week 0 versus week 13 and week 0 versus week 14)
Glucose control is indicated by postprandial glucose concentration, which will be assessed using a standardized meal test.
Change in Cardiac function
Time frame: Changes from baseline (week 0) to post intervention (week 13)
Cardiac function is indicated by diastolic strain rate, which will be assessed using magnetic resonance imaging.
3 secondary outcomes
Recruitment rate
Time frame: Response rate to up to seven months of recruitment
Feasibility and acceptability as assessed by Semi-structured interviews
Time frame: Semi-structured interviews will be conducted during (week 5 or 6) and after (week 14) the intervention
Change in Sample size in a full-scale trial
Time frame: Changes from baseline (week 0) to post intervention (week 13)
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 26 Oct 2016.
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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.
Melanie Davies, MD principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indoor rowing in people with Diabetes Mellitus, Type 2 and Glucose Intolerance, run by University of Leicester 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 10 inclusion and 16 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 26 Oct 2016. 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 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 in Glucose control (time frame: Changes from baseline (week 0) to post intervention (week 0 versus week 13 and week 0 versus week 14)). The study lists 2 primary outcomes in all. 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 26 Oct 2016.