Type 2 DiabetesNCT01812590
Acute Exercise and Pancreatic Endocrine Function
A study testing Exercise in people with Type 2 Diabetes, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Subjects with type 2 diabetes will be stratified into two-quantiles based on ambient hyperglycemia (fasting glucose and HbA1c) and then the effects of a single aerobic exercise bout (1-hour at 50%VO2max) on pancreatic endocrine function will be determined. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Oct 2013
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous diagnosis with type 2 diabetes, or newly detected in our screening procedures
- Age 30-70 years
- BMI 20-40 kg/m2
Who cannot join
- Treatment with insulin
- Contraindication to exercise as determined by ECG
- Pregnancy
- Active weight loss in the previous 6 months
- Actively engaged in exercise training programs
- Evidence of chronic pulmonary, cardiovascular, hepatic, renal, or hematological disease
Trial locations and contacts
1 site in 1 country.
About this study
Subjects with type 2 diabetes will be stratified into two-quantiles based on ambient hyperglycemia (fasting glucose and HbA1c) and then the effects of a single aerobic exercise bout (1-hour at 50%VO2max) on pancreatic endocrine function will be determined.
- Conditions
- Type 2 Diabetes
- Being tested
- Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Resting Trial | No intervention | Pancreatic endocrine function will be determined the morning following a day where no exercise is performed |
| Exercise Trial | Experimental | Pancreatic endocrine function will be determined the morning following a day where a 1-hour aerobic exercise is performed at 65% of pre-determined HRmax (maximal heart rate measured during an incremental work-load exercise test to volitional exhaustion) Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic endocrine function
Insulin and glucagon secretory responses to intravenous glucose (hyperglycemic clamp 5.4 mmol/l above basal), glucagon-like peptide-1 (0.5 pmol/kg/min), and arginine (5 g injection) will be determined.
Measured: 24-hours following a period of rest/exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- 14 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812590
- Sponsor's protocol ID
- Ex-Panc
- Status last verified
- Jan 2014
- First submitted
- 14 Mar 2013
- Last updated
- 31 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Exercise and Pancreatic Endocrine Function
- ClinicalTrials.gov ID
- NCT01812590
- Acronym / sponsor ID
- Ex-Panc
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Mar 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.
Subjects with type 2 diabetes will be stratified into two-quantiles based on ambient hyperglycemia (fasting glucose and HbA1c) and then the effects of a single aerobic exercise bout (1-hour at 50%VO2max) on pancreatic endocrine function will be determined.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resting Trial | No intervention | –Pancreatic endocrine function will be determined the morning following a day where no exercise is performed |
| Exercise Trial | Experimental | Behavioral: ExercisePancreatic endocrine function will be determined the morning following a day where a 1-hour aerobic exercise is performed at 65% of pre-determined HRmax (maximal heart rate measured during an incremental work-load exercise test to volitional exhaustion) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Previous diagnosis with type 2 diabetes, or newly detected in our screening procedures
- Age 30-70 years
- BMI 20-40 kg/m2
Key exclusion criteria (6 listed)
- Treatment with insulin
- Contraindication to exercise as determined by ECG
- Pregnancy
- Active weight loss in the previous 6 months
- Actively engaged in exercise training programs
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 | Exercise Trial |
Primary outcome
Pancreatic endocrine function
Time frame: 24-hours following a period of rest/exercise
Insulin and glucagon secretory responses to intravenous glucose (hyperglycemic clamp 5.4 mmol/l above basal), glucagon-like peptide-1 (0.5 pmol/kg/min), and arginine (5 g injection) will be determined.
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 31 Jan 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Type 2 Diabetes, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 6 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 31 Jan 2014. 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 Denmark. 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?
Pancreatic endocrine function (time frame: 24-hours following a period of rest/exercise). 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 31 Jan 2014.