Training Effects on Skeletal Muscle Fatty Acid Metabolism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00786487
First received: November 5, 2008
Last updated: July 22, 2015
Last verified: July 2015
Results First Received: May 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Basic Science
Condition: Healthy Volunteers
Interventions: Drug: 20% lipid infusion
Drug: glycerol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
we had anticipated enrollment of 36 subjects but ended up finishing the study with 33 subjects

Reporting Groups
  Description
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,


Participant Flow:   Overall Study
    Lipid Trained     Glycerol Trained     Lipid Untrained     Glycerol Untrained  
STARTED     10     7     9     7  
COMPLETED     10     7     9     7  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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,

Total Total of all reporting groups

Baseline Measures
    Lipid Trained     Glycerol Trained     Lipid Untrained     Glycerol Untrained     Total  
Number of Participants  
[units: participants]
  10     7     9     7     33  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     10     7     9     7     33  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  25  (6)     24  (3)     21  (2)     21  (2)     23  (4)  
Gender  
[units: participants]
         
Female     5     3     4     3     15  
Male     5     4     5     4     18  
Region of Enrollment  
[units: participants]
         
United States     10     7     9     7     33  
insulin sensitivity  
[units: M value]
Mean (Standard Deviation)
  13.5  (3.5)     12  (3)     7  (1.6)     9  (3)     10.7  (3.6)  



  Outcome Measures

1.  Primary:   Insulin Sensitivity as Measured by Hyperinsulinemic Euglycemic Clamp at a Single Time Point (6 Hrs) After Intralipid or Glycerol Infusion   [ Time Frame: at 6 hours after starting lipid/glycerol infusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: chow0007@umn.edu


No publications provided by University of Minnesota - Clinical and Translational Science Institute

Publications automatically indexed to this study:

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00786487     History of Changes
Other Study ID Numbers: 0804M29862, pending
Study First Received: November 5, 2008
Results First Received: May 29, 2015
Last Updated: July 22, 2015
Health Authority: United States: Food and Drug Administration