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Training Effects on Skeletal Muscle Fatty Acid Metabolism

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ClinicalTrials.gov Identifier: NCT00786487
Recruitment Status : Completed
First Posted : November 6, 2008
Results First Posted : July 23, 2015
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Basic Science
Condition Healthy Volunteers
Interventions Drug: 20% lipid infusion
Drug: glycerol
Enrollment 33
Recruitment Details  
Pre-assignment Details we had anticipated enrollment of 36 subjects but ended up finishing the study with 33 subjects
Arm/Group Title Lipid Trained Glycerol Trained Lipid Untrained Glycerol Untrained
Hide Arm/Group Description

20% lipid infusion in trained subjects

20% lipid infusion: 1.5 ml/min for 6 hours

glycerol infusion into trained subjects

glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,

lipid infusion into untrained subjects

20% lipid infusion: 1.5 ml/min for 6 hours

glycerol infusion into untrained subjects

glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,

Period Title: Overall Study
Started 10 7 9 7
Completed 10 7 9 7
Not Completed 0 0 0 0
Arm/Group Title Lipid Trained Glycerol Trained Lipid Untrained Glycerol Untrained Total
Hide Arm/Group Description

20% lipid infusion in trained subjects

20% lipid infusion: 1.5 ml/min for 6 hours

glycerol infusion into trained subjects

glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,

lipid infusion into untrained subjects

20% lipid infusion: 1.5 ml/min for 6 hours

glycerol infusion into untrained subjects

glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,

Total of all reporting groups
Overall Number of Baseline Participants 10 7 9 7 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 7 participants 9 participants 7 participants 33 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
7
 100.0%
9
 100.0%
7
 100.0%
33
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 7 participants 9 participants 7 participants 33 participants
25  (6) 24  (3) 21  (2) 21  (2) 23  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 7 participants 9 participants 7 participants 33 participants
Female
5
  50.0%
3
  42.9%
4
  44.4%
3
  42.9%
15
  45.5%
Male
5
  50.0%
4
  57.1%
5
  55.6%
4
  57.1%
18
  54.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 7 participants 9 participants 7 participants 33 participants
10 7 9 7 33
insulin sensitivity  
Mean (Standard Deviation)
Unit of measure:  M value
Number Analyzed 10 participants 7 participants 9 participants 7 participants 33 participants
13.5  (3.5) 12  (3) 7  (1.6) 9  (3) 10.7  (3.6)
1.Primary Outcome
Title Insulin Sensitivity as Measured by Hyperinsulinemic Euglycemic Clamp at a Single Time Point (6 Hrs) After Intralipid or Glycerol Infusion
Hide Description Insulin sensitivity (M value: Glucose infusion rate/kg FFM/min)measured at single time point 6 hours after initiating either intralipid or glycerol infusion)
Time Frame at 6 hours after starting lipid/glycerol infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lipid Trained Glycerol Trained Lipid Untrained Glycerol Untrained
Hide Arm/Group Description:

20% lipid infusion in trained subjects

20% lipid infusion: 1.5 ml/min for 6 hours

glycerol infusion into trained subjects

glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,

lipid infusion into untrained subjects

20% lipid infusion: 1.5 ml/min for 6 hours

glycerol infusion into untrained subjects

glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,

Overall Number of Participants Analyzed 10 7 9 6
Mean (Standard Deviation)
Unit of Measure: M value
8  (3) 12  (2) 6  (2) 11  (4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lipid Trained, Glycerol Trained
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lipid Untrained, Glycerol Untrained
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lipid Trained Glycerol Trained Lipid Untrained Glycerol Untrained
Hide Arm/Group Description

20% lipid infusion in trained subjects

20% lipid infusion: 1.5 ml/min for 6 hours

glycerol infusion into trained subjects

glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,

lipid infusion into untrained subjects

20% lipid infusion: 1.5 ml/min for 6 hours

glycerol infusion into untrained subjects

glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,

All-Cause Mortality
Lipid Trained Glycerol Trained Lipid Untrained Glycerol Untrained
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lipid Trained Glycerol Trained Lipid Untrained Glycerol Untrained
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/7 (0.00%)      0/9 (0.00%)      0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lipid Trained Glycerol Trained Lipid Untrained Glycerol Untrained
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/10 (10.00%)      1/7 (14.29%)      0/9 (0.00%)      0/6 (0.00%)    
Musculoskeletal and connective tissue disorders         
numbness * 1 [1]  1/10 (10.00%)  1 1/7 (14.29%)  1 0/9 (0.00%)  0 0/6 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedRA
[1]
slight skin numbness at site of muscle biopsy
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Lisa Chow
Organization: University of Minnesota
Phone: 612-625-8934
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00786487     History of Changes
Other Study ID Numbers: 0804M29862
pending ( Other Grant/Funding Number: pending )
First Submitted: November 5, 2008
First Posted: November 6, 2008
Results First Submitted: May 29, 2015
Results First Posted: July 23, 2015
Last Update Posted: July 23, 2015