An interventional study of Steady-state hyperglycemia and Fluctuating hyperglycemia in Aerobic Exercise, Hyperglycemia and Glucose Metabolism Disorders (Including Diabetes Mellitus), sponsored by University of Birmingham. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-11.
Sponsored by University of Birmingham · Not applicable, Interventional, and Basic science
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Among 33 studies in Hyperglycemia with a site in United Kingdom — 2 open to participants now, 3 under way, none of them phase 3. Hyperglycemia · United Kingdom.
Among the 33 studies in Hyperglycemia with a site in United Kingdom, this one is the 26th largest by enrollment of the 30 interventional ones that give a count, is one of 6 that started in 2017, is one of 23 with no phase, and was the 16th registered.
801 studies on the registry are indexed under Hyperglycemia; 115 are open to participants now.
Browse Hyperglycemia studies →2 of the 33 studies in Hyperglycemia with a site in United Kingdom are open now. Recruiting first, the newest first:
Imperial College London · Sites in United Kingdom
Ages 18+ · Healthy volunteers
Imperial College Healthcare NHS Trust · Sites in United Kingdom
Ages 18+
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 71 Hyperglycemia studies recruiting now, 42 (59%) set no upper age limit and 23 (32%) stop at 75 or younger; 10 take children under 18; 15 take healthy volunteers.
This study: 18 Years to 50 Years · male · healthy volunteers too.
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33 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 12 is below the median of 50 across 621 interventional studies indexed under Hyperglycemia.
Median enrollment 28 across the 30 interventional studies, 70 across the 3 observational. Of the 29 that completed or were terminated, 6 (21%) have results posted.
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6 of 33 have an industry lead sponsor. The 10 most frequent:
University of Birmingham is the lead sponsor of 182 studies on the registry; 29 are open to participants now.
University of Birmingham has 2 studies filed under Hyperglycemia — fewer than ten, so there is no comparison to draw.
1 of the studies in Hyperglycemia 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 |
|---|---|
| NCT06318442Imperial College LondonThe GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes | 2027-06-01 |
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Among the 33 studies in Hyperglycemia with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This study will determine whether exposure to short-term high blood glucose levels impairs exercise-induced adaptations in glucose tolerance, and whether the pattern of high blood glucose levels plays a role.
Healthy male volunteers will undergo a screening visit and four experimental trials.
Screening Visit: Having read the participant info sheet, a study investigator will discuss the project with the potential participant who will have the chance to ask any questions. Informed consent will be sought and a General Health Questionnaire will be completed. Body weight, height, and skinfold measurements will be taken. Participants will also complete an exercise test to measure V̇O2max test along with heart rate and blood pressure measurements.
Individuals eligible for inclusion in the study will then return to the lab for four experimental trials, each separated by \~1 week. Trials will be completed using a randomised, counter-balanced, cross-over design. Between experimental trials, participants will be instructed to maintain their normal diet and activity habits. During the 48 hours prior to each experimental trial participants will be instructed to refrain from vigorous exercise and alcohol. For 3 days prior to each experimental trial, participants will record their dietary intake, and wear an accelerometer and a continuous glucose monitor to measure physical activity levels and glucose control.
Experimental Trials: Participants will arrive at the laboratory in the morning (\~8 am) following an overnight (\~10 hour) fast from food and drink (except water) since 10pm the previous evening. Upon entering the laboratory, body composition (height, weight, waist circumference) will be assessed and a cannula will be placed into a vein in each arm (one for infusion of glucose, one for blood sampling). Resting cardiovascular measures (heart rate, blood pressure, oxygen saturation) will be collected followed by an assessment of cognitive function followed immediately by one of the four 3.5 hour interventions:
After 3.5 hours, the above-described glycaemic intervention will stop, and be followed immediately by the collection of post-intervention blood samples, assessment of cardiovascular response and assessment of cognitive function. Participants will then complete an exercise bout consisting of 45 minutes of moderate intensity (70% HRmax) continuous cycling, during which energy expenditure will be measured by indirect calorimetry. Post-exercise blood samples will be collected, and catheters will be removed. Participants will be fed a meal. Before leaving the lab, they will also be provided with an evening meal to be consumed at home at 7 pm, and a breakfast and lunch meal for the following day (to be consumed at 7 am and 12 pm, respectively). Participants will then return to the laboratory for 5 minutes the afternoon after the trial day (\~3 pm) to remove the accelerometer and continuous glucose monitor, marking the end of the trial.
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.
Exclusion Criteria:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be studied in the fasting state under normal blood glucose conditions whereby no glucose will be administered, but an exercise bout will be completed.
Behavioral: Exercise
Participants will be studied during experimental steady-state hyperglycemia-induced via a variable-rate intravenous glucose infusion, and an exercise bout will be completed.
Procedure: Steady-state hyperglycemia · Behavioral: Exercise
Participants will be studied during experimental fluctuating hyperglycemia-induced via repeated intravenous glucose injections, and an exercise bout will be completed.
Procedure: Fluctuating hyperglycemia · Behavioral: Exercise
Participants will be studied in the fasting state under normal blood glucose conditions whereby no glucose will be administered and no exercise will be completed.
Experimental "diabetic like" steady-state hyperglycemia will be induced via a continuous-rate intravenous glucose infusion.
Also known as: Drug (metabolite infusion)
Experimental "diabetic like" fluctuating hyperglycemia will be induced via repeated intravenous glucose injections.
Also known as: Drug (metabolite injection)
Moderate-intensity exercise bout (45-minutes of cycling at 70% of their heart rate max) at T=4.5 hours
Exercise-induced change in blood glucose control.
In all trials, continuous glucose monitoring (CGM) will be used to assess the change in glucose control compared to baseline for 24 hours after-exercise, under diet-controlled but otherwise free-living conditions.
Time frame: In all trials, glucose control will be determined between the time-point immediately after exercise and 24 hours after exercise.
Hyperglycemia-induced change in inflammation.
In all trials, plasma cytokine levels (IL-6, TNF-alpha, IL-1ra) will be measured at baseline (T=0 hours) and immediately after each glycaemic intervention (T=3.5 hours). The interventions will take place between baseline (T=0 hours) and T=3.5 hours.
Time frame: In all trials, inflammation will be determined at baseline (T=0 hours) and at T=3.5 hours. The glycemic interventions take place between baseline (T=0 hours) and T=3.5 hours.
Hyperglycemia-induced change in cognitive function.
In all trials, cognitive function tests (CANTAB) to measure executive functioning and verbal memory will be administered at baseline (T=0 hours) and immediately after each glycaemic intervention (T=3.5 hours). The interventions will take place between baseline (T=0 hours) and T=3.5 hours.
Time frame: In all trials, cognitive function will be determined at baseline (T=0 hours) and at T=3.5 hours. The glycemic interventions take place between baseline (T=0 hours) and T=3.5 hours.
Plan to share: Undecided
Ran from Aug 2017 to primary completion in Nov 2018, 15 months.
Of 208 non-industry interventional studies with no phase under Hyperglycemia, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 27. This study's 15 months is close to that.
Counting every sponsor, half of 225 studies reached it within 14 months; a quarter within 7 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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