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Training Effects on Fuel Metabolism (TrainMeUpMN)

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ClinicalTrials.gov Identifier: NCT02150889
Recruitment Status : Active, not recruiting
First Posted : May 30, 2014
Last Update Posted : January 3, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:

The investigators 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. The investigators are especially interested in learning about the effects of weight and training on insulin resistance. The investigators will study people before and after supervised aerobic or yoga training to identify differences in resting fat and sugar metabolism which may lead to differences in insulin resistance. The investigators will test these differences using stable isotopes, and the use of these stable isotopes is experimental.

Overweight/Obese Group: Eight visits will be required at the University of Minnesota Clinical Research Unit. Four visits will be done before training (screen and 3 pre-training visits), 1 visit during the training, and 3 post-training visits will be done. In between, the training will take about 16 weeks and will be a supervised treadmill program.

Lean/Trained Group: Four visits will be required at the University of Minnesota Clinical Research Unit (screen and 3 study visits).


Condition or disease Intervention/treatment Phase
Healthy Subjects Lean Trained Subjects Overweight and Obesity Behavioral: Running Program Behavioral: Yoga Program Not Applicable

Detailed Description:
Insulin resistance plays a critical role in the development of type 2 diabetes (T2DM), with skeletal muscle the largest site of insulin resistance in the human body. In sedentary humans, insulin resistance correlates with levels of intramyocellular lipid (IMCL) and lipid metabolites that adversely affect skeletal muscle glucose metabolism. However, even modest endurance training has been shown to reduce insulin resistance while increasing skeletal muscle IMCL. Moreover, lean endurance trained participants have IMCL levels comparable to those of patients with T2DM, yet have significantly lower insulin resistance. These findings suggest that the physiological changes caused by training protect against lipid induced insulin resistance and that this protection is present even at rest, however our preliminary data suggest that training facilitates utilization of readily available fuel, with lipid preferentially used over glucose when available. We will test the overarching hypothesis that training increases resting skeletal muscle lipid metabolism, as measured by markers of IMCL lipolysis, accumulation of fatty acid metabolites and mitochondrial utilization of fatty acids.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Training Effects on Fuel Metabolism
Study Start Date : July 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
No Intervention: Lean Trained
Metabolic control
Experimental: Obese or Overweight
Running Program Yoga Program
Behavioral: Running Program
16 week supervised running program

Behavioral: Yoga Program
once weekly supervised yoga




Primary Outcome Measures :
  1. Differences in insulin sensitivity between groups [ Time Frame: Before and after exercise program (exercise program will take 16 weeks, expected average for evaluation will be 20 weeks) ]
    Will use HOMA-IR and hyperinsulinemia-euglycemic clamp


Secondary Outcome Measures :
  1. Differences in fitness level between groups [ Time Frame: before and after exercise program (exercise program will take 16 weeks, expected average for evaluation will be 20 weeks) ]
    we will measure fitness level by treadmill based VO2 max testing.


Other Outcome Measures:
  1. Differences in body composition between groups [ Time Frame: before and after exercise program ((exercise program will take 16 weeks, expected average for evaluation will be 20 weeks) ]
    we will measure body composition by iDEXA to look at changes and total fat, visceral fat, and subcutaneously pre-and post exercise. This will be a noninvasive x-ray based measurement (x-ray exposure is extremely low and is equivalent to 1 day of natural radiation in Minnesota)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All subjects

  1. Subjects 18 to 40 years of age.
  2. Subjects are capable of giving informed consent

Overweight or obese

  1. Insulin resistant based on screening oral glucose tolerance testing.
  2. BMI 25 to 40 kg/m2 inclusive
  3. Stable weight for at least 3 months (± 5 lbs.)
  4. Sedentary status (self-report < 30 minutes/week regular exercise).

Lean, physically active

  1. physically active subjects defined as 3-5 aerobic exercise sessions/week
  2. matched to age and gender
  3. generally healthy with normal fasting glucose levels (glucose ≤100 mg/dL).

Exclusion Criteria:

All subjects

  1. Subjects 18 to 40 years of age.
  2. Subjects are capable of giving informed consent

Overweight or obese

  1. Insulin resistant based on screening oral glucose tolerance testing.
  2. BMI 25 to 40 kg/m2 inclusive
  3. Stable weight for at least 3 months (± 5 lbs.)
  4. Sedentary status (self-report < 30 minutes/week regular exercise).

Lean, physically active

  1. physically active subjects defined as 3-5 aerobic exercise sessions/week
  2. matched to age and gender
  3. generally healthy with normal fasting glucose levels (glucose ≤100 mg/dL).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150889


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Lisa S. Chow, MD University of Minnesota - Clinical and Translational Science Institute

Additional Information:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02150889     History of Changes
Other Study ID Numbers: 1209M20741
5R01DK098203-02 ( U.S. NIH Grant/Contract )
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017

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

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms