An interventional study of Priming exercise and Control Exercise in Type 1 Diabetes Mellitus, sponsored by Liverpool Hope University. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-03-01.
Sponsored by Liverpool Hope University · Not applicable, Interventional, and Basic science
Among 268 studies in Diabetes Mellitus, Type 1 with a site in United Kingdom — 32 open to participants now, 42 under way, 5 of them phase 3. Diabetes Mellitus, Type 1 · United Kingdom.
Among the 268 studies in Diabetes Mellitus, Type 1 with a site in United Kingdom, this one is the 199th largest by enrollment of the 214 interventional ones that give a count, is one of 14 that started in 2018, is one of 106 with no phase, and was the 145th registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
Browse Diabetes Mellitus, Type 1 studies →32 of the 268 studies in Diabetes Mellitus, Type 1 with a site in United Kingdom are open now. Recruiting first, the newest first:
Sanofi · Sites in United Kingdom, Belgium, France and 3 more countries
Eli Lilly and Company · Sites in United Kingdom, United States, Australia and 17 more countries
Eli Lilly and Company · Sites in United Kingdom, United States, Australia and 16 more countries
Imperial College London · Sites in United Kingdom
SAb Biotherapeutics, Inc. · Sites in United Kingdom, United States, Australia and 12 more countries
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.
This study: 18 Years to 40 Years · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
268 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 31 · Phase 3 53 · Phase 4 18
First in 1997; this study’s year is marked. 14 started in 2018.
This study's enrollment of 7 is below the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Median enrollment 50 across the 214 interventional studies, 133 across the 54 observational. Of the 205 that completed or were terminated, 76 (37%) have results posted.
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98 of 268 have an industry lead sponsor. The 10 most frequent:
Liverpool Hope University is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Liverpool Hope University has 1 study filed under Diabetes Mellitus, Type 1 — fewer than ten, so there is no comparison to draw.
15 of the studies in Diabetes Mellitus, Type 1 with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04598893Provention Bio, a Sanofi CompanyRecent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension) | 2026-11 |
| NCT07457580SanofiReal-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) | 2026-11-30 |
| NCT06782568Imperial College LondonAvoidance of Insulin-induced Lipohypertophy in People With Diabetes Using Ultrasound Scanning Within Diabetes Clinics | 2026-12-31 |
| NCT07583238University of NottinghamDiathermy On Diabetes Glucose Monitoring Effectiveness | 2027-02 |
| NCT06815081University of OxfordCapillary OGTT Study | 2027-02-28 |
Among the 268 studies in Diabetes Mellitus, Type 1 with a site in United Kingdom, from their registry updates:
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Critical power is an important threshold in exercise physiology, and is an important determinant of the ability to tolerate high-intensity exercise. The ability to tolerate such exercise is drastically impaired in certain chronic conditions, such as type 1 diabetes. Whilst the most important physiological factors that determine critical power have yet to be determined, previous work from our laboratory suggests that it is related to the speed of oxygen uptake at the onset of exercise. This study will look to utilise "priming" exercise as an intervention to improve the speed of these oxygen uptake "kinetics", and thus critical power and exercise tolerance in individuals with type 1 diabetes. We hypothesize that oxygen uptake kinetics will be faster and critical power will be higher when exercise is performed with compared to without a prior bout of high-intensity priming exercise in a population of individuals with type 1 diabetes.
The ability to tolerate high-intensity exercise, or exercise tolerance, is a key factor that can influence clinical outcomes in a range of conditions. The "critical power" is an important physiological threshold that demarcates exercise intensities that can be sustained for prolonged periods (i.e. below critical power) from intensities that result in exhaustion in a relatively short period of time (i.e. 2-30 minutes, above critical power). Critical power is therefore a key determinant of exercise tolerance. The speed with which oxygen uptake rises at the onset of exercise (i.e. oxygen uptake "kinetics") has been shown by work from our laboratory to be a key determinant of critical power. One intervention that can acutely improve the oxygen uptake kinetics is the performance of a prior bout of high-intensity exercise, known as "priming exercise". Patients with type 1 diabetes have previously been shown to have impaired exercise tolerance compared to healthy controls. The performance of priming exercise therefore represents a potential intervention to acutely improve oxygen uptake kinetics, and therefore critical power and exercise tolerance, in type 1 diabetic individuals. The purpose of this study is therefore to assess the influence of priming exercise on oxygen uptake kinetics and critical power in a population of type 1 diabetic individuals.
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.
Suffering from Type 1 diabetes with a diagnosed disease duration of 2 - 20 years and no comorbidities.
Exclusion Criteria:
History of stroke, congestive heart failure, hypertension, or cardiopulmonary disease.
Current smoking or have been smoking within the last 12 months Symptomatic autonomic or distal neuropathy > 64 mmol/mol Hypoglycaemia unawareness in the last 6 months Taking any medications other than insulin.
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.
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.
Participants will perform constant power output tests at four separate, fixed intensities to exhaustion on a cycle ergometer on separate days. These exhaustive, constant power tests will be preceded by 3 minutes of light cycling, 6 minutes of high intensity cycling, 7 minutes of rest and 3 minutes of light cycling.
Behavioral: Priming exercise
Participants will perform constant power output tests at four separate, fixed intensities to exhaustion on a cycle ergometer on separate days. These exhaustive, constant power tests will be preceded by 3 minutes of light cycling only.
Behavioral: Control Exercise
All participants will perform a bout of high-intensity "priming" exercise for 6 minutes, 10 minutes prior to undertaking an exhaustive exercise test on four separate occasions.
All participants will perform 3 minutes of baseline cycling prior to undertaking an exhaustive exercise test on four separate occasions.
Critical power
The power asymptote of the hyperbolic relationship between power and the tolerable duration of exercise.
Time frame: 3-9 weeks
Phase II time constant of pulmonary oxygen uptake kinetics
Time taken for oxygen uptake to attain 63% of its asymptotic amplitude.
Time frame: 3-9 weeks
Time constant for muscle deoxygenation kinetics (assessed by near-infrared spectroscopy)
Time taken for muscle deoxyhaemoglobin to attain 63% of its asymptotic amplitude.
Time frame: 3-9 weeks
W'
Curvature constant of the power-duration relationship. Finite work capacity available above critical power.
Time frame: 3-9 weeks
Time constant for heart rate kinetics
Time taken for heart rate to attain 63% of its asymptotic amplitude.
Time frame: 3-9 weeks
Plan to share: No — Anonymized participant data will be made available to the public in the form of research presentations and a journal article. Anonymized individual participant data not featured in either the journal article or presentations will only be made available upon request to the authors.
Ran from Jan 2018 to primary completion in Dec 2018, 11 months.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 11 months is below that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Liverpool Hope University