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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acipimox | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 7 to 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene Schauer, M.D., Ph.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
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6 participants screen failed prior to starting the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acipimox, Then Placebo | Subjects will take acipimox 250mg (random order crossover and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit, followed by Placebo pill 250 mg by mouth four times a day for six days prior to the visit and one dose the morning of study visit |
| FG001 | Placebo, Then Acipimox | Subjects will take a placebo pill 250mg (random order crossover and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit, followed by acipimox pill 250 mg by mouth four times a day for six days prior to the visit and one dose the morning of study visit |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Acipimox, then Placebo Subjects will take acipimox 250mg (random order crossover and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit, followed by Placebo pill 250 mg by mouth four times a day for six days prior to the visit and one dose the morning of study visit Placebo, then Acipimox Subjects will take a placebo pill 250mg (random order crossover and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit, followed by acipimox pill 250 mg by mouth four times a day for six days prior to the visit and one dose the morning of study visit |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This measure was originally entered as a secondary outcome in error. A registered component of this outcome measure, "peak exercise cardiac function", was not collected. This is consistent with the protocol. One participant's data could not be collected. | Posted | Mean | Standard Deviation | seconds | 7 to 9 days |
|
Up to 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acipimox | 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 Acipimox: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Irene Schauer, MD | University of Colorado Denver | 3037241111 | clinicalresearchsupportcenter@ucdenver.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D009043 | Motor Activity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C027696 | acipimox |
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|
| Placebo | Drug | 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. |
|
| 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. | 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. | 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) | 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. | 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 | 7 to 9 days |
| Triglycerides | 7 to 9 days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | 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 Placebo: 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. |
|
|
| Primary | 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. | This measure was originally entered as a secondary outcome in error. A registered component of this outcome measure, "peak exercise cardiac function", was not collected. This is consistent with the protocol. One participant's data could not be collected. | Posted | Mean | Standard Deviation | ml/kg/min | 7 to 9 days |
|
|
|
| Secondary | 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. | This outcome measure was originally registered as a primary outcome in error. One participant's data could not be collected. | Posted | Mean | Standard Deviation | mg/kg LBM/min/micro IU insulin/ml | 7 to 9 days |
|
|
|
| Secondary | 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. | A registered component of this outcome measure, "peak exercise cardiac function", was not collected. This is consistent with the protocol. One participant's data could not be collected. | Posted | Mean | Standard Deviation | beats/minute | 7 to 9 days |
|
|
|
| Secondary | 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. | A registered component of this outcome measure, "peak exercise cardiac function", was not collected. This is consistent with the protocol. One participant's data could not be collected. | Posted | Mean | Standard Deviation | Watts | 7 to 9 days |
|
|
|
| Secondary | 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) | This outcome measure was originally registered as a primary outcome in error. One participant's data could not be collected. | Posted | Mean | Standard Deviation | mg/L | 7 to 9 days |
|
|
|
| Secondary | 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. | This outcome measure was originally registered as a primary outcome in error. | Posted | Mean | Standard Deviation | % change | 7 to 9 days |
|
|
|
| Secondary | 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 | This outcome measure was originally registered as a primary outcome in error. | Posted | Mean | Standard Deviation | percent | 7 to 9 days |
|
|
|
| Secondary | Triglycerides | One participant's data could not be collected. | Posted | Mean | Standard Deviation | mg/dl | 7 to 9 days |
|
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|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Placebo | 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 Placebo: 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. | 0 | 7 | 0 | 7 | 0 | 7 |
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| D001519 | Behavior |
| D006946 | Hyperinsulinism |