Type 1 DiabetesPhase 3AcT1NCT01816165

Effects of Acipimox on Insulin Action, Vascular Function, and Muscle Function in Type 1 Diabetes

A Phase 3 study testing Acipimox in people with Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Type 1 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: 28 participants
Where: 1 siteUnited States
Study dates: Jun 2011to 24 Jun 2015
Phase: Phase 3
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 25 to 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Men and women, with and without type 1 diabetes between 25-59 years of age,
HbA1c 6.0-9.5 (T1D only),
Subjects who are willing to commit to:
14 days of prescribed diet,
two 44 hour inpatient stays, and
two muscle biopsies.

Who cannot join

Any comorbid condition associated with inflammation, insulin resistance, or dyslipidemia,
Tobacco use,
Pregnancy,
Steroid use,
Scheduled physical activity >3 days a week,
Angina or any other cardiovascular or pulmonary disease,

Show all 16Show fewer

History of chronic obstructive pulmonary disease or asthma,
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
Creatinine > 2 mg/dl, suggestive of severe renal disease,
Severe Proliferative retinopathy,
Niacin treatment,
History of peptic ulcers,
History of hereditary angioedema, and
C1 esterase deficiency.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Denver
Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Role of Lipotoxicity in Insulin Resistance, Vascular, and Mitochondrial Dysfunction in Type 1 Diabetes

Insulin resistance (IR) is an important contributor to increased cardiovascular disease risk in type 1 diabetes (T1D). Non-esterified fatty acid elevation is a significant contributor to IR in T1D and may be a target of intervention. The hypothesis of the study is that isolated fatty acid lowering with acipimox will improve insulin action and blood vessel function and have the benefit of reducing mitochondrial oxidant generation and improving mitochondrial function in T1D. Targeting IR through fatty acid lowering is a novel approach to T1D treatment that may significantly improve current management of TID and of cardiovascular disease (CVD) risk in this high risk population.

Conditions: Type 1 Diabetes
Being tested: Acipimox, Placebo
Keywords: diabetes, insulin, blood vessel, type 1
Medical subject headings: Diabetes Mellitus, Type 1, Diabetes Mellitus, 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 by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day.
PlaceboDrug
Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day

Study groups in NCT01816165
Study group	Role	What they receive
Acipimox	Experimental	Drug: acipimox Receives: Drug: Acipimox
Placebo	Placebo comparator	Drug: Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Insulin Sensitivity: M-value From Hyperinsulinemic Euglycemia Clamp Study
Evaluate the impact of Non esterified fatty acid (NEFA)-lowering on insulin sensitivity in T1D versus non-DM. Glucose infusion rate is reported normalized to lean body weight in kg and to final insulin concentration.
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: day 8 of each of the 2 random order intervention phases; max 16 weeks post enrollment
24 Hour Mean Fatty Acid Levels
Assesses whether fatty acid level is consistently lowered by acipimox. Mean of fatty acid levels measured 22 times over 24 hours (hourly except 0100 and 0300 hours).
Measured: day 6 to 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Percent Flow-mediated Brachial Artery Dilation
To determine the effects of NEFA lowering and insulin sensitization on endothelial function. Measures percent change in brachial artery diameter with hyperemia after occlusion.
Measured: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
State 3 Mitochondrial Oxygen Consumption
Measures skeletal muscle mitochondrial function and effects of acipimox thereon, carbohydrate \& lipid substrates. State 3 is fully active coupled oxygen flux using PMG or PMGS (pyruvate, malate, glutamate, +/- succinate) or OCMS (octanyl carnitine, malate, +/- succinate) as substrates. FCCP is added as an uncoupler to measure maximum possible O2 flux. Higher values reflect better mitochondrial function.
Measured: muscle biopsy on day 7 of each weeklong intervention period; max 16 weeks post enrollment

Secondary outcomes (13)

Oxidative Stress and Inflammatory Markers: Interleukin 6 (IL6)
Interleukin 6 (IL6)
Measured: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Oxidative Stress and Inflammatory Markers: TNFalpha
TNFalpha
Measured: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Oxidative Stress and Inflammatory Markers: High-sensitivity C-reactive Protein (hsCRP)
high-sensitivity C-reactive protein (hsCRP)
Measured: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Oxidative Stress and Inflammatory Markers: Adiponectin
adiponectin
Measured: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Oxidative Stress and Inflammatory Markers: Plasminogen Activator Inhibitor (PAI-1)
Plasminogen activator inhibitor (PAI-1)
Measured: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Heart Rate Variability
Measure of autonomic function; ratio of fastest to slowest heart rate during valsalva maneuver.
Measured: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Arterial Stiffness (PWV)
Pulse wave velocity by Sphygmacor as a measure of aortic stiffness in m/sec. Higher values reflect a stiffer vasculature.
Measured: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Arterial Stiffness (AI)
Augmentation index by Sphygmacor is a measure of aortic arterial stiffness. AI@75 is the ratio of augmented pressure/pulse pressure adjusted to a heart rate of 75.
Higher values indicate stiffer vessels
Measured: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Metabolic Markers: Continuous Glucose Monitoring Measures
Continuous glucose monitoring measures for 3 days before clamp. Collected for participants with T1 Diabetes only.
Measured: day 6 to 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Metabolic Markers: Mean 24 Hour Triglyceride and Glucose Levels
mean glucose and triglycerides for the 24 hours before the 2nd overnight stay from 22 hourly measurements over 24 hours (except 0100 and 0300).
Measured: day 6 to 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Metabolic Markers: Insulin
mean insulin for the 24 hours before the 2nd overnight stay from 22 hourly measurements over 24 hours (except 0100 and 0300).
Measured: day 6 to 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Metabolic Markers: Glycerol
mean glycerol for the 24 hours before the 2nd overnight stay from 22 hourly measurements over 24 hours (except 0100 and 0300).
Measured: day 6 to 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Vascular Markers
endothelin 1 measured as a marker of vascular damage
Measured: day 6 to 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201124 Jun 2015

First posted22 Mar 2013 (estimated)
Study startJun 2011
Primary completion24 Jun 2015
Study completion24 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 1 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01816165
Sponsor's protocol ID: 11-0649
Other IDs: 6181
Acronym: AcT1
Status last verified: Dec 2021
First submitted: 13 Jun 2012
Last updated: 21 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Role of Lipotoxicity in Insulin Resistance, Vascular, and Mitochondrial Dysfunction in Type 1 Diabetes
ClinicalTrials.gov ID: NCT01816165
Acronym / sponsor ID: AcT1 / 11-0649
Conditions: Type 1 Diabetes
Keywords: diabetes, insulin, blood vessel, type 1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Study start: Jun 2011
Primary completion: 24 Jun 2015 (actual)
Study completion: 24 Jun 2015 (actual)
First posted: 22 Mar 2013 (estimated)
Results: Posted 21 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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: AcipimoxDrug: acipimox
Placebo	Placebo comparator	Drug: PlaceboDrug: Placebo

Who may qualify

Ages: 25 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Men and women, with and without type 1 diabetes between 25-59 years of age,
HbA1c 6.0-9.5 (T1D only),
Subjects who are willing to commit to:

Key exclusion criteria (16 listed)

Any comorbid condition associated with inflammation, insulin resistance, or dyslipidemia,
Tobacco use,
Pregnancy,
Steroid use,
Scheduled physical activity >3 days a week,

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 by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day.	Drug	Acipimox
PlaceboSubjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day	Drug	Placebo

Primary outcome

Insulin Sensitivity: M-value From Hyperinsulinemic Euglycemia Clamp Study
Time frame: day 8 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Evaluate the impact of Non esterified fatty acid (NEFA)-lowering on insulin sensitivity in T1D versus non-DM. Glucose infusion rate is reported normalized to lean body weight in kg and to final insulin concentration. 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.
24 Hour Mean Fatty Acid Levels
Time frame: day 6 to 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Assesses whether fatty acid level is consistently lowered by acipimox. Mean of fatty acid levels measured 22 times over 24 hours (hourly except 0100 and 0300 hours).
Percent Flow-mediated Brachial Artery Dilation
Time frame: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
To determine the effects of NEFA lowering and insulin sensitization on endothelial function. Measures percent change in brachial artery diameter with hyperemia after occlusion.
State 3 Mitochondrial Oxygen Consumption
Time frame: muscle biopsy on day 7 of each weeklong intervention period; max 16 weeks post enrollment
Measures skeletal muscle mitochondrial function and effects of acipimox thereon, carbohydrate \& lipid substrates. State 3 is fully active coupled oxygen flux using PMG or PMGS (pyruvate, malate, glutamate, +/- succinate) or OCMS (octanyl carnitine, malate, +/- succinate) as substrates. FCCP is added as an uncoupler to measure maximum possible O2 flux. Higher values reflect better mitochondrial function.

13 secondary outcomes

Oxidative Stress and Inflammatory Markers: Interleukin 6 (IL6)
Time frame: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Oxidative Stress and Inflammatory Markers: TNFalpha
Time frame: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Oxidative Stress and Inflammatory Markers: High-sensitivity C-reactive Protein (hsCRP)
Time frame: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Oxidative Stress and Inflammatory Markers: Adiponectin
Time frame: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Oxidative Stress and Inflammatory Markers: Plasminogen Activator Inhibitor (PAI-1)
Time frame: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Heart Rate Variability
Time frame: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Arterial Stiffness (PWV)
Time frame: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Arterial Stiffness (AI)
Time frame: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Metabolic Markers: Continuous Glucose Monitoring Measures
Time frame: day 6 to 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Metabolic Markers: Mean 24 Hour Triglyceride and Glucose Levels
Time frame: day 6 to 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Metabolic Markers: Insulin
Time frame: day 6 to 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Metabolic Markers: Glycerol
Time frame: day 6 to 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment
Vascular Markers
Time frame: day 6 to 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment

Results and safety

Results posted to the registry on 21 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With T1 Diabetes: Acipimox, Then Placebo	5	4
Participants Without T1 Diabetes: Acipimox, Then Placebo	4	4
Participants With T1 Diabetes: Placebo, Then Acipimox	5	5
Participants Without T1 Diabetes: Placebo, Then Acipimox	4	4

Primary outcome: Insulin Sensitivity: M-value From Hyperinsulinemic Euglycemia Clamp Study

Time frame: day 8 of each of the 2 random order intervention phases; max 16 weeks post enrollment. Mean (Standard Deviation). Unit: mg/kg*minute*microIU/mL*100

Measure	T1 Diabetes, Acipimox n = 9	T1 Diabetes, Placebo n = 9	No T1 Diabetes, Acipimox n = 8	No T1 Diabetes, Placebo n = 8
Value	4.65 (1.52)	3.67 (1.45)	8.8 (3.04)	9.05 (2.88)

Population analysed: 1 participant in the T1 Diabetes groups was excluded from the analysis because data was only collected in the Acipimox phase and matching Placebo data would have been required for comparison.

Primary outcome: 24 Hour Mean Fatty Acid Levels

Time frame: day 6 to 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment. Mean (Standard Deviation). Unit: microEq/L

Measure	T1 Diabetes, Acipimox n = 9	T1 Diabetes, Placebo n = 9	No T1 Diabetes, Acipimox n = 8	No T1 Diabetes, Placebo n = 8
Value	343 (122)	297 (56)	298 (90)	335 (65)

Primary outcome: Percent Flow-mediated Brachial Artery Dilation

Time frame: day 7 of each of the 2 random order intervention phases; max 16 weeks post enrollment. Mean (Standard Deviation). Unit: Percent change in BA diameter

Measure	T1 Diabetes, Acipimox n = 9	T1 Diabetes, Placebo n = 9	No T1 Diabetes, Acipimox n = 8	No T1 Diabetes, Placebo n = 8
Value	8.21 (3.02)	8.82 (4.40)	5.88 (4.17)	7.32 (4.25)

Primary outcome: State 3 Mitochondrial Oxygen Consumption

Time frame: muscle biopsy on day 7 of each weeklong intervention period; max 16 weeks post enrollment. Mean (Standard Deviation). Unit: pmoles/mg/s

Measure	T1 Diabetes, Acipimox n = 8	T1 Diabetes, Placebo n = 9	No T1 Diabetes, Acipimox n = 8	No T1 Diabetes, Placebo n = 8
PMG State 3 Oxygen Flux	26.1 (8.3)	24.9 (7.6)	30.2 (9.8)	29.7 (10.0)
PMGS State 3 Oxygen Flux	38.0 (11.8)	36.9 (12.7)	42.5 (15.0)	42.5 (11.8)
PMGS Uncoupled Max Oxygen Flux	65.2 (18.4)	62.1 (16.3)	77.8 (26.3)	80.2 (28.9)
OCM State 3 Oxygen Flux	14.0 (5.8)	15.0 (5.6)	18.8 (8.6)	17.3 (4.4)
OCMS State 3 Oxygen Flux	38.6 (14.6)	38.5 (11.2)	43.8 (13.3)	41.7 (9.9)
OCMS Uncoupled Max Oxygen Flux	51.8 (22.9)	56.4 (20.0)	80.1 (24.8)	73.1 (18.8)

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to about Week 16. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T1 Diabetes, Acipimox	1 of 10 (10%)	0 of 10 (0%)	0 of 10
T1 Placebo	0 of 9 (0%)	0 of 9 (0%)	0 of 9
No T1 Diabetes, Acipimox	0 of 8 (0%)	0 of 8 (0%)	0 of 8
No T1 Placebo	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Limitations and caveats (from the sponsor): This study was stopped early for two reasons: one was the serious adverse event and the other was the fact that the fatty acid lowering effect of acipimox was more short-lived than expected and we did not see the intended overall fatty acid lowering.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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, MD, PhD 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 Phase 3 study testing Acipimox in people with Type 1 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 6 inclusion and 16 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 21 Jan 2022. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jan 2022). 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?

Insulin Sensitivity: M-value From Hyperinsulinemic Euglycemia Clamp Study (time frame: day 8 of each of the 2 random order intervention phases; max 16 weeks post enrollment). The study lists 4 primary outcomes in all. 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 NCT01816165.

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 21 Jan 2022.