Trial Outcomes & Findings for Effects of Acipimox on Mitochondrial Function in Obesity (NCT NCT01488409)

NCT ID: NCT01488409

Last Updated: 2016-03-01

Results Overview

The rate of recovery of phosphocreatine concentration after depletion by exercise is considered a measurement of mitochondrial function. Change in phosphocreatine recovery from baseline to 6 months will therefore give a measurement of change in mitochondrial function. ViPCR is given -- a higher value indicates better mitochondrial function.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Change from Baseline to 6-months Visit

Results posted on

2016-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Acipimox Treatment with the study drug Acipimox Acipimox: 250 mg by mouth (PO) three times daily	Placebo Treatment with Placebo control. Placebo: 0 mg by mouth (PO) three times daily
Overall Study STARTED	20	19
Overall Study COMPLETED	16	15
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Acipimox on Mitochondrial Function in Obesity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acipimox n=20 Participants Treatment with the study drug Acipimox Acipimox: 250 mg by mouth (PO) three times daily	Placebo n=19 Participants Treatment with Placebo control. Placebo: 0 mg by mouth (PO) three times daily	Total n=39 Participants Total of all reporting groups
Age, Continuous	47 years STANDARD_DEVIATION 5 • n=5 Participants	45 years STANDARD_DEVIATION 7 • n=7 Participants	46 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized White	8 participants n=5 Participants	10 participants n=7 Participants	18 participants n=5 Participants
Race/Ethnicity, Customized Black	12 participants n=5 Participants	8 participants n=7 Participants	20 participants n=5 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	19 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline to 6-months Visit

Population: all available data used

The rate of recovery of phosphocreatine concentration after depletion by exercise is considered a measurement of mitochondrial function. Change in phosphocreatine recovery from baseline to 6 months will therefore give a measurement of change in mitochondrial function. ViPCR is given -- a higher value indicates better mitochondrial function.

Outcome measures

Outcome measures
Measure	Acipimox n=16 Participants Treatment with the study drug Acipimox Acipimox: 250 mg by mouth (PO) three times daily	Placebo n=12 Participants Treatment with Placebo control. Placebo: 0 mg by mouth (PO) three times daily
Change From Baseline in Phosphocreatine Recovery (ViPCr) at 6-months	1.7 mM/s Standard Deviation 9.6	1.6 mM/s Standard Deviation 10.8

SECONDARY outcome

Timeframe: Change from Baseline to 6-months visit

Population: all available data used

Change in insulin resistance assessed by hyperinsulinemic-euglycemic clamp study at Baseline and at 6-months. Change in insulin-stimulated glucose uptake (M) during 40 mU/m2/min insulin clamp is given.

Outcome measures

Outcome measures
Measure	Acipimox n=15 Participants Treatment with the study drug Acipimox Acipimox: 250 mg by mouth (PO) three times daily	Placebo n=14 Participants Treatment with Placebo control. Placebo: 0 mg by mouth (PO) three times daily
Change From Baseline in Insulin Sensitivity at 6-months	0.1 mg/kg/min Standard Deviation 1.9	0.2 mg/kg/min Standard Deviation 1.4

SECONDARY outcome

Timeframe: Change from Baseline to 6-months

Population: all available data used

Muscle tissue obtained from biopsy will be used to assess mitochondrial number and morphology by microscopes at Baseline and at 6-months. The change in mitochondrial density from 6 months to baseline is given.

Outcome measures

Outcome measures
Measure	Acipimox n=8 Participants Treatment with the study drug Acipimox Acipimox: 250 mg by mouth (PO) three times daily	Placebo n=9 Participants Treatment with Placebo control. Placebo: 0 mg by mouth (PO) three times daily
Change From Baseline in Mitochondrial Density at 6 Months	0.4 percentage of total muscle fiber area Standard Deviation 1.3	0 percentage of total muscle fiber area Standard Deviation 1.6

SECONDARY outcome

Timeframe: Change from Baseline to 6-months

Population: all available data used

Change in tibialis intramyocellular lipid (IMCL) normalized to creatinine is given.

Outcome measures

Outcome measures
Measure	Acipimox n=14 Participants Treatment with the study drug Acipimox Acipimox: 250 mg by mouth (PO) three times daily	Placebo n=15 Participants Treatment with Placebo control. Placebo: 0 mg by mouth (PO) three times daily
Change From Baseline in Intramyocellular Lipid Content at 6-months	-0.2 ratio of IMCL peak to Creatinine peak Standard Deviation 3.0	0.0 ratio of IMCL peak to Creatinine peak Standard Deviation 2.3

SECONDARY outcome

Timeframe: Change from Baseline to 6-months

Population: all available data used

Change in direct low density lipoprotein (LDL) cholesterol is given

Outcome measures

Outcome measures
Measure	Acipimox n=16 Participants Treatment with the study drug Acipimox Acipimox: 250 mg by mouth (PO) three times daily	Placebo n=15 Participants Treatment with Placebo control. Placebo: 0 mg by mouth (PO) three times daily
Change From Baseline in Lipid Profile at 6-months	-19 mg/dL Standard Deviation 26	6 mg/dL Standard Deviation 22

Adverse Events

Acipimox

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Acipimox n=20 participants at risk Treatment with the study drug Acipimox Acipimox: 250 mg by mouth (PO) three times daily	Placebo n=19 participants at risk Treatment with Placebo control. Placebo: 0 mg by mouth (PO) three times daily
Skin and subcutaneous tissue disorders Flushing	40.0% 8/20 • 6 months	21.1% 4/19 • 6 months
Gastrointestinal disorders nausea	20.0% 4/20 • 6 months	15.8% 3/19 • 6 months
General disorders Dizziness	5.0% 1/20 • 6 months	5.3% 1/19 • 6 months
Gastrointestinal disorders abdominal bloating	15.0% 3/20 • 6 months	10.5% 2/19 • 6 months
General disorders dry mouth	5.0% 1/20 • 6 months	0.00% 0/19 • 6 months
Gastrointestinal disorders gastroesophageal reflux	35.0% 7/20 • 6 months	26.3% 5/19 • 6 months
Surgical and medical procedures pain following biopsy	0.00% 0/20 • 6 months	5.3% 1/19 • 6 months
Surgical and medical procedures bleeding following biopsy	5.0% 1/20 • 6 months	5.3% 1/19 • 6 months
Gastrointestinal disorders abdominal pain	10.0% 2/20 • 6 months	10.5% 2/19 • 6 months
Gastrointestinal disorders diarrhea	35.0% 7/20 • 6 months	10.5% 2/19 • 6 months
Gastrointestinal disorders vomiting	0.00% 0/20 • 6 months	5.3% 1/19 • 6 months
Musculoskeletal and connective tissue disorders joint pain and swelling	5.0% 1/20 • 6 months	0.00% 0/19 • 6 months
Gastrointestinal disorders constipation	0.00% 0/20 • 6 months	5.3% 1/19 • 6 months
Skin and subcutaneous tissue disorders rash	5.0% 1/20 • 6 months	0.00% 0/19 • 6 months
General disorders loss of appetite	0.00% 0/20 • 6 months	5.3% 1/19 • 6 months

Additional Information

Steven K. Grinspoon

Massachusetts General Hospital

Phone: 617-724-9109

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place