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Training Effects on Skeletal Muscle Fatty Acid Metabolism

This study is ongoing, but not recruiting participants.
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: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

We are interested in how skeletal muscle processes fat and how this may affect insulin resistance. This is an important question since insulin resistance predates and predicts type 2 diabetes. We know that if pharmaceutical grade fat is infused into people, they develop insulin resistance. Likewise, we would like to infuse pharmaceutical grade fat into trained subjects, believing that trained subjects will have less insulin resistance, less decline in muscle energy function, and less accumulation of fat metabolites than untrained subjects. For comparing the effects of the pharmaceutical grade fat infusion, we will also have a group of trained and untrained subjects given a control (glycerol) infusion. Glycerol is basically the same as pharmaceutical grade fat infusion without the fat component.


Condition Intervention
Healthy Subjects
 Drug: 20% lipid infusion
Drug: glycerol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Training Effects on Skeletal Muscle Fatty Acid Metabolism

Resource links provided by NLM:

Drug Information available for: Glycerin
U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • change in insulin resistance as measured by hyperinsulinemic euglycemic clamp [ Time Frame: within 6 hours after starting infusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: January 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lipid trained
20% lipid infusion in trained subjects
 Drug: 20% lipid infusion
1.5 ml/min for 6 hours
Other Names:
  • Intralipid
  • triglyceride infusion
  • lipid infusion
  • fat infusion
Active Comparator: glycerol trained
glycerol infusion into trained subjects
 Drug: glycerol
glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,
Other Names:
  • Control infusion
  • glycerol infusion
  • glycerol
Experimental: lipid untrained
lipid infusion into untrained subjects
 Drug: 20% lipid infusion
1.5 ml/min for 6 hours
Other Names:
  • Intralipid
  • triglyceride infusion
  • lipid infusion
  • fat infusion
Active Comparator: glycerol untrained
glycerol infusion into untrained subjects
 Drug: glycerol
glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,
Other Names:
  • Control infusion
  • glycerol infusion
  • glycerol

Detailed Description:

We are interested in how skeletal muscle processes fat and its effect on insulin resistance. This is an important question since insulin resistance predates and predicts type 2 diabetes. We know that if pharmaceutical grade lipid is infused into people, they develop insulin resistance. Thus, we would like to infuse pharmaceutical grade lipid into trained subjects, believing that trained subjects will develop less insulin resistance, less decline in muscle energy function, and less accumulation of fat metabolites than untrained subjects. For comparing the effects of the pharmaceutical grade fat infusion, we will also have a group of trained and untrained subjects given a control (glycerol) infusion. Glycerol is basically the same as pharmaceutical grade lipid infusion without the lipid component.

Three visits will be required. The first visit will involve measurement of fitness. A second visit will involve measurement of insulin resistance. The third visit will involve an inpatient stay, with a six hour infusion either the lipid or glycerol. Three muscle biopsies (before, during and after) will be take in conjunction with the infusion.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Regardless of training status, age range will be from age 18 to 45. We will be limiting the upper age range because increased age is associated with sarcopenia and alteration of fiber type 29 and we would like to limit the confounding effects of age.
  • We will define the lean group by a BMI of < 25 kg/m2. Weight must be stable [+/- 5 pounds] for at least the three months prior to the study for all participants.
  • The untrained subjects must not be engaged in a regular exercise program (< 30 minutes regular exercise over 1 week).
  • The trained subjects should be participating in regular running exercise (> 45 min/day, ≥ 5 days/week) and preferably be currently or recently participating in competitions (within 2 years).

Exclusion Criteria:

  • Regardless of training status, subjects must not be on medications that may affect lipid levels, specifically lipid lowering agents, birth control pills or diuretics.
  • The subjects should not be on a high fat diet (> 45% fat) as measured by a screening questionnaire. We will also administer a PAR-Q questionnaire (attached) to establish whether the subject will be safe for exercise testing. - The female subjects must not be pregnant. A pregnancy test will be performed prior to all study visits.
  • If screening TG are > 300 (based on 1st visit results) or fasting glucose > 100 (based on 1st visit results), the subjects will be excluded.
  • If the subject is allergic to eggs (used in lipid emulsions), soybeans(used in lipid emulsions), or lipid emulsions the subject will be excluded from the study.
  • Subjects taking anti-platelet agents (if anti-platelet agent cannot be held for seven days) and subjects taking anticoagulation therapy will be excluded.
  • Subjects with clinically significant medical issues or a history of hematologic (platelets < 100), hepatic (LFTs > 2X nl), renal (Cr > 1.5), pulmonary, or cardiac abnormalities (including abnormal EKG) will also be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786487

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Lisa S Chow, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
insulin resistance
lipid metabolism
lipid infusion
 glycerol infusion
skeletal muscle
diabetes

Additional relevant MeSH terms:
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013