Trial Outcomes & Findings for Training Effects on Skeletal Muscle Fatty Acid Metabolism (NCT NCT00786487)

NCT ID: NCT00786487

Last Updated: 2015-07-23

Results Overview

Insulin sensitivity (M value: Glucose infusion rate/kg FFM/min)measured at single time point 6 hours after initiating either intralipid or glycerol infusion)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: at 6 hours after starting lipid/glycerol infusion
• Results posted on: 2015-07-23

Participant Flow

we had anticipated enrollment of 36 subjects but ended up finishing the study with 33 subjects

Participant milestones

Measure	Lipid Trained 20% lipid infusion in trained subjects 20% lipid infusion: 1.5 ml/min for 6 hours	Glycerol Trained glycerol infusion into trained subjects glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,	Lipid Untrained lipid infusion into untrained subjects 20% lipid infusion: 1.5 ml/min for 6 hours	Glycerol Untrained glycerol infusion into untrained subjects glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,
Overall Study STARTED	10	7	9	7
Overall Study COMPLETED	10	7	9	7
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Training Effects on Skeletal Muscle Fatty Acid Metabolism

Baseline characteristics by cohort

Measure	Lipid Trained n=10 Participants 20% lipid infusion in trained subjects 20% lipid infusion: 1.5 ml/min for 6 hours	Glycerol Trained n=7 Participants glycerol infusion into trained subjects glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,	Lipid Untrained n=9 Participants lipid infusion into untrained subjects 20% lipid infusion: 1.5 ml/min for 6 hours	Glycerol Untrained n=7 Participants glycerol infusion into untrained subjects glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	33 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	25 years STANDARD_DEVIATION 6 • n=5 Participants	24 years STANDARD_DEVIATION 3 • n=7 Participants	21 years STANDARD_DEVIATION 2 • n=5 Participants	21 years STANDARD_DEVIATION 2 • n=4 Participants	23 years STANDARD_DEVIATION 4 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	15 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	18 Participants n=21 Participants
Region of Enrollment United States	10 participants n=5 Participants	7 participants n=7 Participants	9 participants n=5 Participants	7 participants n=4 Participants	33 participants n=21 Participants
insulin sensitivity	13.5 M value STANDARD_DEVIATION 3.5 • n=5 Participants	12 M value STANDARD_DEVIATION 3 • n=7 Participants	7 M value STANDARD_DEVIATION 1.6 • n=5 Participants	9 M value STANDARD_DEVIATION 3 • n=4 Participants	10.7 M value STANDARD_DEVIATION 3.6 • n=21 Participants

PRIMARY outcome

Timeframe: at 6 hours after starting lipid/glycerol infusion

Insulin sensitivity (M value: Glucose infusion rate/kg FFM/min)measured at single time point 6 hours after initiating either intralipid or glycerol infusion)

Outcome measures

Measure	Lipid Trained n=10 Participants 20% lipid infusion in trained subjects 20% lipid infusion: 1.5 ml/min for 6 hours	Glycerol Trained n=7 Participants glycerol infusion into trained subjects glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,	Lipid Untrained n=9 Participants lipid infusion into untrained subjects 20% lipid infusion: 1.5 ml/min for 6 hours	Glycerol Untrained n=6 Participants glycerol infusion into untrained subjects glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,
Insulin Sensitivity as Measured by Hyperinsulinemic Euglycemic Clamp at a Single Time Point (6 Hrs) After Intralipid or Glycerol Infusion	8 M value Standard Deviation 3	12 M value Standard Deviation 2	6 M value Standard Deviation 2	11 M value Standard Deviation 4

Adverse Events

Lipid Trained

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Glycerol Trained

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Lipid Untrained

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Glycerol Untrained

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lipid Trained n=10 participants at risk 20% lipid infusion in trained subjects 20% lipid infusion: 1.5 ml/min for 6 hours	Glycerol Trained n=7 participants at risk glycerol infusion into trained subjects glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,	Lipid Untrained n=9 participants at risk lipid infusion into untrained subjects 20% lipid infusion: 1.5 ml/min for 6 hours	Glycerol Untrained n=6 participants at risk；n=7 participants at risk glycerol infusion into untrained subjects glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,
Musculoskeletal and connective tissue disorders numbness	10.0% 1/10 • Number of events 1	14.3% 1/7 • Number of events 1	0.00% 0/9	0.00% 0/6

Additional Information

Dr. Lisa Chow

University of Minnesota

Phone: 612-625-8934

Email: chow0007@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place