Type 1 DiabetesNCT01771614
Glucotoxicity and Acute Exercise
A study testing Exercise and Hyperglycemia in people with Type 1 Diabetes and Type 2 Diabetes, run by Copenhagen University Hospital, Rigshospitalet at 1 site in United Kingdom.
Trial summary
Experimental hyperglycemia (5 hours) will be induced via a constant- or fluctuating-rate glucose infusion to establish different patterns of glycemia in healthy individuals. The effects of these acute models of hyperglycemia on the adaptations to a single aerobic exercise bout will be tested. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Exercise and Hyperglycemia
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to Jan 2017
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Age 18-50 years
- Body Mass Index 19-30 kg/m2
- Generally healthy
Who cannot join
- Regular use of anti-inflammatory medication
- Smokers
- More than 2 kg weight change in prior 6 months
- Previous weight loss surgery
- Cancer, or evidence of chronic haematological, pulmonary, cardiac, hepatic, renal, or gastrointestinal disease
- Evidence of diabetes
- Engaged in moderate or vigorous activity on more than 5 days per week
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Birmingham
Birmingham, West Midlands, B15 2TT
About this study
Official title: The Effects of Hyperglycaemia on the Response to Acute Exercise
Experimental hyperglycemia (5 hours) will be induced via a constant- or fluctuating-rate glucose infusion to establish different patterns of glycemia in healthy individuals. The effects of these acute models of hyperglycemia on the adaptations to a single aerobic exercise bout will be tested. Changes in pancreatic endocrine function, insulin sensitivity, endothelial function, and oxidative stress will be measured.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- Exercise, Hyperglycemia
- Keywords
- Glucotoxicity, Exercise, Beta-cell function
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
HyperglycemiaProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Normoglycemia + exercise | Experimental | At T = 0 h participants will undergo an intravenous glucose tolerance test (IVGTT, 0.33 g/kg glucose) immediately followed by a 4-hour rest period. At T = 5 h, participants will undertake 45 minutes of moderate-intensity (70% VO2max) bicycle ergometry. Immediately following (T = 6 h) and 1- (T = 7 h), 3- (T = 9 h), and 18- hours (T = 24 h) after exercise, participants will undergo additional IVGTTs. Receives: Behavioral: Exercise |
| Steady-State Hyperglycemia + exercise | Experimental | At T = 0 h participants will undergo an intravenous glucose tolerance test (IVGTT, 0.33 g/kg glucose) immediately followed by a 4-hour rest period. During this time, steady-state hyperglycemia (~10 mM) will be induced experimentally via a variable-rate intravenous infusion of 20% dextrose. At T = 5 h, participants will undertake 45 minutes of moderate-intensity (70% VO2max) bicycle ergometry. Immediately following (T = 6 h) and 1- (T = 7 h), 3- (T = 9 h), and 18- hours (T = 24 h) after exercise, participants will undergo additional IVGTTs. Receives: Behavioral: Exercise; Procedure: Hyperglycemia |
| Fluctuating Hyperglycemia + exercise | Experimental | At T = 0 h participants will undergo an intravenous glucose tolerance test (IVGTT, 0.33 g/kg glucose) immediately followed by a 4-hour rest period. During this time, fluctuating hyperglycemia (~8-15 mM) will be induced by intravenously injecting 0.15 g/kg boluses of 20% dextrose every 30 minutes. At T = 5 h, participants will undertake 45 minutes of moderate-intensity (70% VO2max) bicycle ergometry. Immediately following (T = 6 h) and 1- (T = 7 h), 3- (T = 9 h), and 18- hours (T = 24 h) after exercise, participants will undergo additional IVGTTs. Receives: Behavioral: Exercise; Procedure: Hyperglycemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic endocrine function
The plasma insulin, C-peptide, and glucagon responses to a 0.33 g/kg intravenous glucose tolerance test (IVGTT) will be measured. In each trial, the IVGTT will be performed at T = 0, 6, 7, 9, and 24 hours.
Measured: 0, 6, 7, 9, and 24 hours
Secondary outcomes (3)
Glucose tolerance
Glucose tolerance will be measured during an IVGTT in each trial at T = 0, 6, 7, 9, and 24 hours.
Measured: 0, 6, 7, 9, and 24 hours
Endothelial function
Blood flow and flow-mediated dilation by Doppler ultrasound will be measured in each trial at T = 0, 6, 7, 9, and 24 hours.
Measured: 0, 6, 7, 9, and 24 hours
Oxidative stress
Urine will be collected over the whole 24-hour period of each trial and 8-iso Prostaglandin F3α will be measured.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startAug 2016 (estimated)
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Why it stopped: PI relocated to a different country.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Solomon, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Thomas P Solomon, PhD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771614
- Sponsor's protocol ID
- GlucotoxEx
- Status last verified
- May 2018
- First submitted
- 16 Jan 2013
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hyperglycaemia on the Response to Acute Exercise
- ClinicalTrials.gov ID
- NCT01771614
- Acronym / sponsor ID
- GlucotoxEx
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- Glucotoxicity, Exercise, Beta-cell function
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI relocated to a different country.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Aug 2016 (estimated)
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 18 Jan 2013 (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.
Experimental hyperglycemia (5 hours) will be induced via a constant- or fluctuating-rate glucose infusion to establish different patterns of glycemia in healthy individuals. The effects of these acute models of hyperglycemia on the adaptations to a single aerobic exercise bout will be tested. Changes in pancreatic endocrine function, insulin sensitivity, endothelial function, and oxidative stress will be measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normoglycemia + exercise | Experimental | Behavioral: ExerciseAt T = 0 h participants will undergo an intravenous glucose tolerance test (IVGTT, 0.33 g/kg glucose) immediately followed by a 4-hour rest period. At T = 5 h, participants will undertake 45 minutes of moderate-intensity (70% VO2max) bicycle ergometry. Immediately following (T = 6 h) and 1- (T = 7 h), 3- (T = 9 h), and 18- hours (T = 24 h) after exercise, participants will undergo additional IVGTTs. |
| Steady-State Hyperglycemia + exercise | Experimental | Behavioral: Exercise, Procedure: HyperglycemiaAt T = 0 h participants will undergo an intravenous glucose tolerance test (IVGTT, 0.33 g/kg glucose) immediately followed by a 4-hour rest period. During this time, steady-state hyperglycemia (~10 mM) will be induced experimentally via a variable-rate intravenous infusion of 20% dextrose. At T = 5 h, participants will undertake 45 minutes of moderate-intensity (70% VO2max) bicycle ergometry. Immediately following (T = 6 h) and 1- (T = 7 h), 3- (T = 9 h), and 18- hours (T = 24 h) after exercise, participants will undergo additional IVGTTs. |
| Fluctuating Hyperglycemia + exercise | Experimental | Behavioral: Exercise, Procedure: HyperglycemiaAt T = 0 h participants will undergo an intravenous glucose tolerance test (IVGTT, 0.33 g/kg glucose) immediately followed by a 4-hour rest period. During this time, fluctuating hyperglycemia (~8-15 mM) will be induced by intravenously injecting 0.15 g/kg boluses of 20% dextrose every 30 minutes. At T = 5 h, participants will undertake 45 minutes of moderate-intensity (70% VO2max) bicycle ergometry. Immediately following (T = 6 h) and 1- (T = 7 h), 3- (T = 9 h), and 18- hours (T = 24 h) after exercise, participants will undergo additional IVGTTs. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- Age 18-50 years
- Body Mass Index 19-30 kg/m2
- Generally healthy
Key exclusion criteria (7 listed)
- Regular use of anti-inflammatory medication
- Smokers
- More than 2 kg weight change in prior 6 months
- Previous weight loss surgery
- Cancer, or evidence of chronic haematological, pulmonary, cardiac, hepatic, renal, or gastrointestinal disease
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 |
|---|---|---|
| Exercise | Behavioural | Fluctuating Hyperglycemia + exercise, Normoglycemia + exercise, Steady-State Hyperglycemia + exercise |
| Hyperglycemia | Procedure or surgery | Fluctuating Hyperglycemia + exercise, Steady-State Hyperglycemia + exercise |
Primary outcome
Pancreatic endocrine function
Time frame: 0, 6, 7, 9, and 24 hours
The plasma insulin, C-peptide, and glucagon responses to a 0.33 g/kg intravenous glucose tolerance test (IVGTT) will be measured. In each trial, the IVGTT will be performed at T = 0, 6, 7, 9, and 24 hours.
3 secondary outcomes
Glucose tolerance
Time frame: 0, 6, 7, 9, and 24 hours
Endothelial function
Time frame: 0, 6, 7, 9, and 24 hours
Oxidative stress
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
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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.
Thomas P Solomon, 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 Exercise and Hyperglycemia in people with Type 1 Diabetes and Type 2 Diabetes, run by Copenhagen University Hospital, Rigshospitalet 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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 16 May 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 withdrawn before enrolling participants, so there are no results.
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?
Pancreatic endocrine function (time frame: 0, 6, 7, 9, and 24 hours). 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 16 May 2018.