Type 2 DiabetesPhase 2HFDMNCT01213784
Optimized Glycemic Control in Heart Failure Patients With DM2:"Effect on Left Ventricular Function and Skeletal Muscle"
A Phase 2 study testing all antidiabetic drugs will be appliable in people with Type 2 Diabetes and Heart Failure, run by University of Aarhus at 1 site in Denmark.
Trial summary
The investigators wish to investigate wether a more strict diabetic control improves cardiac function, muscle strength, exercise capacity and decreases symptoms. The investigators hypothesis is that improving the glycemic control in suboptimized diabetics with heart failure will improve cardiac performance, muscle… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Type 2 Diabetes, Heart Failure
- What is being tested?
- all antidiabetic drugs will be appliable
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Nov 2012
- Phase
- Phase 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ejection fraction =<45%
- Diabetes
- Hba1c =>7,5%
- In anticongestive treatment
- NYHA class 2-4
Who cannot join
- Severe angina (CCS 3-4)
- Hemodynamic significant heart valve disease
- Congenital heart disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of cardiology, Aarhus university hospital Skejby
Aarhus, Central Jutland, 8200
About this study
Official title: Optimized Glycemic Control in Type 2 Diabetics With Heart Failure:"Effect on Left Ventricular Function and Skeletal Muscle"
The investigators wish to investigate wether a more strict diabetic control improves cardiac function, muscle strength, exercise capacity and decreases symptoms.
The investigators hypothesis is that improving the glycemic control in suboptimized diabetics with heart failure will improve cardiac performance, muscle strength, exercise capacity and decrease symptoms.
- Conditions
- Type 2 Diabetes, Heart Failure
- Being tested
- all antidiabetic drugs will be appliable
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
all antidiabetic drugs will be appliableOther
We expect all participants to be set on insulin during the intervention, however all types of insulin and other antidiabetics can be used goal: Hba1c lower than 7,5%
| Study group | Role | What they receive |
|---|---|---|
| optimized diabetic control | Experimental | each participant will be assigned to be optimized in a dedicated diabetic clinic Receives: Other: all antidiabetic drugs will be appliable |
| control | No intervention | participants will be assigned to follow what ever control they were in before the study and not to change any antidiabetic treatment during the interventions period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular function
Left ventricular function will be evaluated using echocardiografi measuring:
- 2D Ejection fraction (using an ultrasound agent), global and regional tissue velocity, Strain / strain rate - all measures done during rest and dobutamin stress test.
Measured: 4 month
Secondary outcomes (4)
hormonal and metabolic profile
bloodsamples
Measured: 4 month
6-minutes hall walk test
using a hall walk protocol
Measured: 4 month
Exercise capacity and peak oxygen consumption
using a treadmill test and continues oxygen consumption measurement
Measured: 4 month
Muscle strength and mass
muscle strength: hand grip test
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2012
- Study completionNov 2012
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Roni R Nielsen, MD, Principal investigator, Dept. of cardiology, University hospital Aarhus Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213784
- Sponsor's protocol ID
- M20090047
- Acronym
- HFDM
- Status last verified
- Jun 2013
- First submitted
- 24 Aug 2010
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nielsen R, Wiggers H, Thomsen HH, Bovin A, Refsgaard J, Abrahamsen J, Moller N, Botker HE, Norrelund H. Effect of tighter glycemic control on cardiac function, exercise capacity, and muscle strength in heart failure patients with type 2 diabetes: a randomized study. BMJ Open Diabetes Res Care. 2016 Apr 29;4(1):e000202. doi: 10.1136/bmjdrc-2016-000202. eCollection 2016.
PubMed 27158520
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Glycemic Control in Type 2 Diabetics With Heart Failure:"Effect on Left Ventricular Function and Skeletal Muscle"
- ClinicalTrials.gov ID
- NCT01213784
- Acronym / sponsor ID
- HFDM / M20090047
- Conditions
- Type 2 Diabetes, Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish Diabetes Association
- Study start
- Sep 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 4 Oct 2010 (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.
The investigators wish to investigate wether a more strict diabetic control improves cardiac function, muscle strength, exercise capacity and decreases symptoms.
The investigators hypothesis is that improving the glycemic control in suboptimized diabetics with heart failure will improve cardiac performance, muscle strength, exercise capacity and decrease symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| optimized diabetic control | Experimental | Other: all antidiabetic drugs will be appliableeach participant will be assigned to be optimized in a dedicated diabetic clinic |
| control | No intervention | –participants will be assigned to follow what ever control they were in before the study and not to change any antidiabetic treatment during the interventions period. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ejection fraction =<45%
- Diabetes
- Hba1c =>7,5%
- In anticongestive treatment
- NYHA class 2-4
Key exclusion criteria (4 listed)
- Severe angina (CCS 3-4)
- Hemodynamic significant heart valve disease
- Congenital heart disease
- Pregnancy
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 |
|---|---|---|
| all antidiabetic drugs will be appliableWe expect all participants to be set on insulin during the intervention, however all types of insulin and other antidiabetics can be used goal: Hba1c lower than 7,5% | Other | optimized diabetic control |
Primary outcome
Left ventricular function
Time frame: 4 month
Left ventricular function will be evaluated using echocardiografi measuring: - 2D Ejection fraction (using an ultrasound agent), global and regional tissue velocity, Strain / strain rate - all measures done during rest and dobutamin stress test.
4 secondary outcomes
hormonal and metabolic profile
Time frame: 4 month
6-minutes hall walk test
Time frame: 4 month
Exercise capacity and peak oxygen consumption
Time frame: 4 month
Muscle strength and mass
Time frame: 4 month
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 6 Mar 2015.
- Derived from this study: PubMed 27158520Nielsen R, Wiggers H, Thomsen HH, Bovin A, Refsgaard J, Abrahamsen J, Moller N, Botker HE, Norrelund H. Effect of tighter glycemic control on cardiac function, exercise capacity, and muscle strength in heart failure patients with type 2 diabetes: a randomized study. BMJ Open Diabetes Res Care. 2016 Apr 29;4(1):e000202. doi: 10.1136/bmjdrc-2016-000202. eCollection 2016.
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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.
Roni R Nielsen, MD principal investigator
Dept. of cardiology, University hospital Aarhus Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing all antidiabetic drugs will be appliable in people with Type 2 Diabetes and Heart Failure, run by University of Aarhus 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 5 inclusion and 4 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 6 Mar 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 phase mean?
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?
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?
Left ventricular function (time frame: 4 month). 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 NCT01213784, 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 6 Mar 2015.