Type 2 DiabetesPhase 1/2NCT02001766
ATP Release and Sympathetic Nerve Activity in Patients With Type II Diabetes
A Phase 1/2 study testing Exercise training in people with Type 2 Diabetes, run by Anders Rasmussen Rinnov at 1 site in Denmark.
Trial summary
Type II diabetes (T2D) is characterized by endothelial dysfunction, resulting in a poor tissue perfusion and function as well as an increased risk of cardiovascular events. ATP, which is released from the red blood cells, contributes to the regulation of the blood flow and studies have shown that red blood cells taken… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to Aug 2016
- Phase
- Phase 1/2
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetics
- BMI >30
- Non smokers
- Physical Inactive (less than 2 hours per week)
Who cannot join
- Thyroid disorder
- Known ischemic heart disease (intermittent claudication, angina)
- Diabetic eye disease
- Diabetic kidney disease
- Known heart disease
- Intake of beta-blockers
Show all 18Show fewer
- Blood Pressure > 140/90
- Nephropathy and macroalbuminuria GFR measurement
- Acute illness within the last three weeks
- Chronic disease, including cancer, heart (ischemic and claudication), liver, kidney and respiratory disorders (asthma)
- Significant peripheral diabetic neuropathy (severe sensory disturbances)
- Significant peripheral diabetic angiopathy (former or current foot ulcer)
- Rheumatological disorders
- Pregnancy or childbirth within the past three months
- Alcohol abuse
- smokers
- Use of illegal performance-enhancing drugs (see IAAF list)
- Injuries and / or surgery within the last 6 months
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641
Copenhagen, 2100
Kamilla Winding, MSc PhD, +45 35459574, kamilla.winding@regionh.dk
About this study
Type II diabetes (T2D) is characterized by endothelial dysfunction, resulting in a poor tissue perfusion and function as well as an increased risk of cardiovascular events. ATP, which is released from the red blood cells, contributes to the regulation of the blood flow and studies have shown that red blood cells taken from T2D patients have an impaired ability to release ATP. However, it is not known whether the changes in the ATP system is an underlying cause of the poor tissue perfusion observed in T2D. The purpose of project 1 is to test the hypothesis that the deterioration in blood flow in T2D is caused by a reduced release ATP from red blood cells, and to test if pharmacological manipulation of cAMP will normalize ATP release, plasma ATP levels and thereby blood flow.
Furthermore, epidemiological studies show a clear link between regular exercise and a reduced risk of serious cardiovascular disease. The extent to which a physically active lifestyle may improve endothelial function in T2D is unknown. Regular physical activity improves vascularization and induces an anti-inflammatory environment. Both the angiogenic and anti-inflammatory effects of physical activity is in part mediated by substances released from the active muscle. These muscle-derived substances are classified as myokines and have paracrine, autocrine and endocrine effects and may thereby affect distant tissues. The purpose of the project 2 is to investigate whether high intensity interval training may reverse endothelial dysfunction in T2D through increased release of ATP and myokines. In individuals with T2D we will determined blood flow in the muscle tissue using advanced ultrasound. In addition, using intravascular and intramuscular microdialysis we will determine ATP levels in blood and in the muscle interstitium.
- Conditions
- Type 2 Diabetes
- Being tested
- Exercise training
- Keywords
- High intensity exercise, Glycemic control, Exercise
- Medical subject headings
- 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.
Exercise trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| High intensity exercise | Experimental | 3 times per week in a total of 12 weeks Receives: Behavioral: Exercise training |
| Low intensity exercise | Experimental | 3 times per week in a total of 12 weeks Receives: Behavioral: Exercise training |
| Control | Experimental | Normal lifestyle for 12 weeks Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose metabolism
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anders Rasmussen Rinnov
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anders Rasmussen Rinnov, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Stefan P. Mortensen, Dr. Med., Study chair, Centre of Inflammation and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001766
- Sponsor's protocol ID
- H-2-2011-070
- Status last verified
- Jun 2015
- First submitted
- 19 Nov 2013
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Groen MB, Knudsen TA, Finsen SH, Pedersen BK, Hellsten Y, Mortensen SP. Reduced skeletal-muscle perfusion and impaired ATP release during hypoxia and exercise in individuals with type 2 diabetes. Diabetologia. 2019 Mar;62(3):485-493. doi: 10.1007/s00125-018-4790-0. Epub 2019 Jan 3.
PubMed 30607464
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATP Release and Sympathetic Nerve Activity in Patients With Type II Diabetes
- ClinicalTrials.gov ID
- NCT02001766
- Acronym / sponsor ID
- H-2-2011-070
- Conditions
- Type 2 Diabetes
- Keywords
- High intensity exercise, Glycemic control, Exercise
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Anders Rasmussen RinnovUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 5 Dec 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.
Type II diabetes (T2D) is characterized by endothelial dysfunction, resulting in a poor tissue perfusion and function as well as an increased risk of cardiovascular events. ATP, which is released from the red blood cells, contributes to the regulation of the blood flow and studies have shown that red blood cells taken from T2D patients have an impaired ability to release ATP. However, it is not known whether the changes in the ATP system is an underlying cause of the poor tissue perfusion observed in T2D. The purpose of project 1 is to test the hypothesis that the deterioration in blood flow in T2D is caused by a reduced release ATP from red blood cells, and to test if pharmacological manipulation of cAMP will normalize ATP release, plasma ATP levels and thereby blood flow.
Furthermore, epidemiological studies show a clear link between regular exercise and a reduced risk of serious cardiovascular disease. The extent to which a physically active lifestyle may improve endothelial function in T2D is unknown. Regular physical activity improves vascularization and induces an anti-inflammatory environment. Both the angiogenic and anti-inflammatory effects of physical activity is in part mediated by substances released from the active muscle. These muscle-derived substances are classified as myokines and have paracrine, autocrine and endocrine effects and may thereby affect distant tissues. The purpose of the project 2 is to investigate whether high intensity interval training may reverse endothelial dysfunction in T2D through increased release of ATP and myokines. In individuals with T2D we will determined blood flow in the muscle tissue using advanced ultrasound. In addition, using intravascular and intramuscular microdialysis we will determine ATP levels in blood and in the muscle interstitium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High intensity exercise | Experimental | Behavioral: Exercise training3 times per week in a total of 12 weeks |
| Low intensity exercise | Experimental | Behavioral: Exercise training3 times per week in a total of 12 weeks |
| Control | Experimental | Behavioral: Exercise trainingNormal lifestyle for 12 weeks |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetics
- BMI >30
- Non smokers
- Physical Inactive (less than 2 hours per week)
Key exclusion criteria (18 listed)
- Thyroid disorder
- Known ischemic heart disease (intermittent claudication, angina)
- Diabetic eye disease
- Diabetic kidney disease
- Known heart 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 training | Behavioural | Control, High intensity exercise, Low intensity exercise |
Primary outcome
Glucose metabolism
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
- Derived from this study: PubMed 30607464Groen MB, Knudsen TA, Finsen SH, Pedersen BK, Hellsten Y, Mortensen SP. Reduced skeletal-muscle perfusion and impaired ATP release during hypoxia and exercise in individuals with type 2 diabetes. Diabetologia. 2019 Mar;62(3):485-493. doi: 10.1007/s00125-018-4790-0. Epub 2019 Jan 3.
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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.
Stefan P. Mortensen, Dr. Med. study chair
Centre of Inflammation and Metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Exercise training in people with Type 2 Diabetes, run by Anders Rasmussen Rinnov 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 4 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 16 Jun 2015. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kamilla Winding, MSc PhD (+4535459574, kamilla.winding@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose metabolism (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02001766, which also lists 1 linked publication.
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 Jun 2015.