Type 2 DiabetesAcT2NCT01580813
Evaluating the Effects of a Study Medication on Exercise Function in Type 2 Diabetes
A study testing Acipimox in people with Type 2 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
People who are overweight or who have type 2 diabetes mellitus (T2DM) have higher levels of certain fats in their blood. The blood vessels and heart of most of these individuals do not work normally and people with T2DM also have an impaired ability to perform exercise. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Acipimox
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to 5 Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sedentary adults not participating in a regular exercise program (≤ one bout of scheduled exercise per week)
- Subjects must have Type 2 Diabetes
- Subjects must be otherwise healthy
- Ages of 30-60 years
- BMI of 25-39 and stable weight for 3 months prior to the start of the study
- Diabetes controlled by diet +/- insulin secretagogues (sulfonylureas or glinides), metformin, or glucose absorption blockers (acarbose).
- Total glycosylated hemoglobin levels (HbA1C) ≤9% (fair control) on current therapy.
Who cannot join
- Any comorbid condition which could limit exercise performance including Chronic Obstructive Pulmonary Disease (COPD) or asthma
- Concurrent enrollment in an interventional study.
- Any tobacco use either current or within the last year
- Clinically evident distal symmetrical neuropathy, determined by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, light touch, ankle jerks), will be excluded.
- Autonomic dysfunction (>20 mm fall in upright BP without a change in heart rate) will be excluded.
- Evidence of ischemic heart disease by history or abnormal resting or exercise electrocardiogram (EKG) (> 1 mm ST segment depression) on screening exercise test.
Show all 17Show fewer
- Angina or any other cardiovascular, pulmonary or musculoskeletal symptoms
- Presence of systolic blood pressure >190 at rest or >250 with exercise or diastolic pressure >95 at rest or >105 with exercise
- Proteinuria (urine protein >200 mg/dl) or a creatinine > 2 mg/dl, suggestive of severe renal disease
- Proliferative retinopathy
- Insulin, incretin, or glitazone treatment
- Niacin treatment
- History of peptic ulcers
- A history of hereditary angioedema
- C1 esterase deficiency
- Women who are pregnant or breastfeeding
- Use of fibrate drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Effects of Serum Fatty Acid Lowering on Insulin Sensitivity, Cardiovascular Function, And Exercise Capacity in Non-Insulin Dependent Diabetes
People who are overweight or who have type 2 diabetes mellitus (T2DM) have higher levels of certain fats in their blood. The blood vessels and heart of most of these individuals do not work normally and people with T2DM also have an impaired ability to perform exercise. The purpose of this study is to use the free fatty acid lowering drug, acipimox, to temporarily decrease the level of fat in the bloodstream of people with T2DM and observe the physiological changes to blood vessel function and exercise capacity and insulin sensitivity. This will help the investigators to understand ways of improving blood vessel function and the ability to exercise effectively in people who are overweight or have T2DM.
- Conditions
- Type 2 Diabetes
- Being tested
- Acipimox, Placebo
- Keywords
- diabetes, exercise, cardiovascular, heart, insulin sensitivity
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcipimoxDrug
Also called Olbetam
Subjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit.
PlaceboDrug
Subjects will take a placebo pill 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit.
| Study group | Role | What they receive |
|---|---|---|
| Acipimox | Experimental | Subjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visi Receives: Drug: Acipimox |
| Placebo | Placebo comparator | Subjects will take a placebo pill 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: VO2 Kinetics
Evaluate the impact of these effects of NEFA-lowering VO2 kinetics as measured by tau2, the time required for VO2 to reach 67% of peak during submaximal exercise.
Measured: 7 to 9 days
Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Peak VO2
Evaluate the impact of these effects of NEFA-lowering on exercise capacity measured as peak VO2.
Measured: 7 to 9 days
Secondary outcomes (7)
Insulin Sensitivity
Test the hypothesis that lowering of endogenous non-essential fatty acids (NEFA) in diabetic adults will improve insulin sensitivity measured as glucose disposal by hyperinsulinemic euglycemic clamp. Unit of measure is mg/kg of lean body mass/min/microIU of insulin/ml.
The unit of measure reflects the rate at which glucose needs to be infused to maintain a normal blood sugar in the setting of a given serum insulin level from an insulin infusion. As such, a higher number means more glucose was needed and indicates greater sensitivity to insulin.
Measured: 7 to 9 days
Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Peak Heart Rate
Evaluate the impact of these effects of NEFA-lowering on exercise parameters, including VO2 kinetics, peak VO2, peak heart rate, peak power output.
Measured: 7 to 9 days
Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Power Output at Anaerobic Threshold and at Peak Exercise
Evaluate the impact of these effects of NEFA-lowering on exercise parameters, including VO2 kinetics, peak VO2, peak heart rate, peak power output.
Measured: 7 to 9 days
Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Inflammation
effect of lowering of endogenous non-essential fatty acids (NEFA) in diabetic adults on inflammation (hsCRP)
Measured: 7 to 9 days
Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Endothelial Function
Test the hypothesis that lowering of endogenous non-essential fatty acids (NEFA) in diabetic adults will improve endothelial function measured by flow mediated dilation of the brachial artery.
Measured: 7 to 9 days
Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Cardiac Function
Test the hypothesis that lowering of endogenous non-essential fatty acids (NEFA) in diabetic adults will improve cardiac function: echo measurement of resting ejection fraction
Measured: 7 to 9 days
Triglycerides
Measured: 7 to 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startJun 2011
- Primary completion5 Jun 2015
- Study completion5 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs, Pfizer
- Responsible party
- Sponsor
- Investigators
- Irene Schauer, M.D., Ph.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580813
- Sponsor's protocol ID
- 10-1393
- Acronym
- AcT2
- Status last verified
- Nov 2021
- First submitted
- 24 May 2011
- Last updated
- 3 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Serum Fatty Acid Lowering on Insulin Sensitivity, Cardiovascular Function, And Exercise Capacity in Non-Insulin Dependent Diabetes
- ClinicalTrials.gov ID
- NCT01580813
- Acronym / sponsor ID
- AcT2 / 10-1393
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes, exercise, cardiovascular, heart, insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs, Pfizer
- Study start
- Jun 2011
- Primary completion
- 5 Jun 2015 (actual)
- Study completion
- 5 Jun 2015 (actual)
- First posted
- 19 Apr 2012 (estimated)
- Results
- Posted 3 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People who are overweight or who have type 2 diabetes mellitus (T2DM) have higher levels of certain fats in their blood. The blood vessels and heart of most of these individuals do not work normally and people with T2DM also have an impaired ability to perform exercise. The purpose of this study is to use the free fatty acid lowering drug, acipimox, to temporarily decrease the level of fat in the bloodstream of people with T2DM and observe the physiological changes to blood vessel function and exercise capacity and insulin sensitivity. This will help the investigators to understand ways of improving blood vessel function and the ability to exercise effectively in people who are overweight or have T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acipimox | Experimental | Drug: AcipimoxSubjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visi |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will take a placebo pill 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Sedentary adults not participating in a regular exercise program (≤ one bout of scheduled exercise per week)
- Subjects must have Type 2 Diabetes
- Subjects must be otherwise healthy
- Ages of 30-60 years
- BMI of 25-39 and stable weight for 3 months prior to the start of the study
Key exclusion criteria (17 listed)
- Any comorbid condition which could limit exercise performance including Chronic Obstructive Pulmonary Disease (COPD) or asthma
- Concurrent enrollment in an interventional study.
- Any tobacco use either current or within the last year
- Clinically evident distal symmetrical neuropathy, determined by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, light touch, ankle jerks), will be excluded.
- Autonomic dysfunction (>20 mm fall in upright BP without a change in heart rate) will be excluded.
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 |
|---|---|---|
| AcipimoxAlso: OlbetamSubjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit. | Drug | Acipimox |
| PlaceboSubjects will take a placebo pill 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit. | Drug | Placebo |
Primary outcome
Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: VO2 Kinetics
Time frame: 7 to 9 days
Evaluate the impact of these effects of NEFA-lowering VO2 kinetics as measured by tau2, the time required for VO2 to reach 67% of peak during submaximal exercise.
Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Peak VO2
Time frame: 7 to 9 days
Evaluate the impact of these effects of NEFA-lowering on exercise capacity measured as peak VO2.
7 secondary outcomes
Insulin Sensitivity
Time frame: 7 to 9 days
Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Peak Heart Rate
Time frame: 7 to 9 days
Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Power Output at Anaerobic Threshold and at Peak Exercise
Time frame: 7 to 9 days
Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Inflammation
Time frame: 7 to 9 days
Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Endothelial Function
Time frame: 7 to 9 days
Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Cardiac Function
Time frame: 7 to 9 days
Triglycerides
Time frame: 7 to 9 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Irene Schauer, M.D., Ph.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acipimox in people with Type 2 Diabetes, run by University of Colorado, Denver at 1 site in United States.
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 7 inclusion and 17 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 3 Dec 2021. 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 States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 3 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: VO2 Kinetics (time frame: 7 to 9 days). The study lists 2 primary outcomes in all. 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 3 Dec 2021.