Training Effects on Skeletal Muscle Fatty Acid Metabolism

NCT00786487 | Completed Results

• 2 other identifiers: 0804M29862pending
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

insulin resistance; lipid metabolism; lipid infusion; glycerol infusion; skeletal muscle; diabetes

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity as Measured by Hyperinsulinemic Euglycemic Clamp at a Single Time Point (6 Hrs) After Intralipid or 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)

  at 6 hours after starting lipid/glycerol infusion

Study Arms (4)

lipid trained

EXPERIMENTAL

20% lipid infusion in trained subjects

Drug: 20% lipid infusion

glycerol trained

ACTIVE COMPARATOR

glycerol infusion into trained subjects

Drug: glycerol

lipid untrained

EXPERIMENTAL

lipid infusion into untrained subjects

Drug: 20% lipid infusion

glycerol untrained

ACTIVE COMPARATOR

glycerol infusion into untrained subjects

Drug: glycerol

Interventions

20% lipid infusion DRUG

1.5 ml/min for 6 hours

Also known as: Intralipid, triglyceride infusion, lipid infusion, fat infusion

lipid trained; lipid untrained

glycerol DRUG

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

Also known as: Control infusion, glycerol infusion

glycerol trained; glycerol untrained

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Chow LS, Seaquist ER, Eberly LE, Mashek MT, Schimke JM, Nair KS, Mashek DG. Acute free fatty acid elevation eliminates endurance training effect on insulin sensitivity. J Clin Endocrinol Metab. 2012 Aug;97(8):2890-7. doi: 10.1210/jc.2012-1515. Epub 2012 May 25.

  PMID: 22639293 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Diabetes Mellitus

Interventions

soybean oil, phospholipid emulsion; Glycerol

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: Dr. Lisa Chow
• Organization: University of Minnesota

chow0007@umn.edu

612-625-8934

Study Officials

• Lisa S Chow, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 6, 2008
• Study Start: January 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: July 23, 2015
• Results First Posted: July 23, 2015

Record last verified: 2015-07

Locations

US (1)