CompletedNot Applicable

Rowing Away From Diabetes

United Kingdom12 participantsStarted 2015-06

Plain-language 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 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.

Who can participate

Age range

45 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * 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 occasi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Glucose control

Timeframe: Changes from baseline (week 0) to post intervention (week 0 versus week 13 and week 0 versus week 14)

Change in Cardiac function

Timeframe: Changes from baseline (week 0) to post intervention (week 13)

Trial details

NCT IDNCT02444156

SponsorUniversity of Leicester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-10

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials