Trial Outcomes & Findings for Evaluating the Effects of a Study Medication on Exercise Function in Type 2 Diabetes (NCT NCT01580813)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

7 to 9 days

Results posted on

2021-12-03

Participant Flow

6 participants screen failed prior to starting the study.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	4	3
Overall Study Completed First Intervention	4	3
Overall Study Completed 1 Week Washout	4	3
Overall Study Started Second Intervention	4	3
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating the Effects of a Study Medication on Exercise Function in Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=7 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 to 9 days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Acipimox n=7 Participants 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.	Placebo n=6 Participants 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.
Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: VO2 Kinetics	51.4 seconds Standard Deviation 16.9	53.3 seconds Standard Deviation 11.8

PRIMARY outcome

Timeframe: 7 to 9 days

Population: 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.

Evaluate the impact of these effects of NEFA-lowering on exercise capacity measured as peak VO2.

Outcome measures

Outcome measures
Measure	Acipimox n=7 Participants 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.	Placebo n=6 Participants 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.
Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Peak VO2	19.7 ml/kg/min Standard Deviation 3.1	18.2 ml/kg/min Standard Deviation 2.6

SECONDARY outcome

Timeframe: 7 to 9 days

Population: This outcome measure was originally registered as a primary outcome in error. One participant's data could not be collected.

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.

Outcome measures

Outcome measures
Measure	Acipimox n=7 Participants 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.	Placebo n=6 Participants 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.
Insulin Sensitivity	6.00 mg/kg LBM/min/micro IU insulin/ml Standard Deviation 1.52	6.04 mg/kg LBM/min/micro IU insulin/ml Standard Deviation 0.69

SECONDARY outcome

Timeframe: 7 to 9 days

Population: 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.

Evaluate the impact of these effects of NEFA-lowering on exercise parameters, including VO2 kinetics, peak VO2, peak heart rate, peak power output.

Outcome measures

Outcome measures
Measure	Acipimox n=7 Participants 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.	Placebo n=6 Participants 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.
Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Peak Heart Rate	148 beats/minute Standard Deviation 11	149 beats/minute Standard Deviation 11

SECONDARY outcome

Timeframe: 7 to 9 days

Population: 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.

Evaluate the impact of these effects of NEFA-lowering on exercise parameters, including VO2 kinetics, peak VO2, peak heart rate, peak power output.

Outcome measures

Outcome measures
Measure	Acipimox n=7 Participants 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.	Placebo n=6 Participants 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.
Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Power Output at Anaerobic Threshold and at Peak Exercise power output at AT	75.8 Watts Standard Deviation 22.9	65.7 Watts Standard Deviation 26.3
Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Power Output at Anaerobic Threshold and at Peak Exercise Power output at peak	138 Watts Standard Deviation 40	129 Watts Standard Deviation 40

SECONDARY outcome

Timeframe: 7 to 9 days

Population: This outcome measure was originally registered as a primary outcome in error. One participant's data could not be collected.

effect of lowering of endogenous non-essential fatty acids (NEFA) in diabetic adults on inflammation (hsCRP)

Outcome measures

Outcome measures
Measure	Acipimox n=7 Participants 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.	Placebo n=6 Participants 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.
Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Inflammation	3.4 mg/L Standard Deviation 1.6	4.3 mg/L Standard Deviation 4.8

SECONDARY outcome

Timeframe: 7 to 9 days

Population: This outcome measure was originally registered as a primary outcome in error.

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.

Outcome measures

Outcome measures
Measure	Acipimox n=7 Participants 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.	Placebo n=7 Participants 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.
Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Endothelial Function	4.9 % change Standard Deviation 3.4	5.3 % change Standard Deviation 3.9

SECONDARY outcome

Timeframe: 7 to 9 days

Population: This outcome measure was originally registered as a primary outcome in error.

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

Outcome measures

Outcome measures
Measure	Acipimox n=7 Participants 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.	Placebo n=7 Participants 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.
Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Cardiac Function	71.4 percent Standard Deviation 5.4	69.9 percent Standard Deviation 4.6

SECONDARY outcome

Timeframe: 7 to 9 days

Population: One participant's data could not be collected.

Outcome measures

Outcome measures
Measure	Acipimox n=7 Participants 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.	Placebo n=6 Participants 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.
Triglycerides	99 mg/dl Standard Deviation 33	134 mg/dl Standard Deviation 43

Adverse Events

Acipimox

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Irene Schauer, MD

University of Colorado Denver

Phone: 3037241111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place