Training Effects on Fuel Metabolism (TrainMeUpMN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT02150889
First received: May 22, 2014
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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 Intervention
Healthy Subjects
Lean Trained Subjects
Overweight or Obese Subjects
Behavioral: Running Program
Behavioral: Yoga Program

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Will use HOMA-IR and hyperinsulinemia-euglycemic clamp


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    we will measure fitness level by treadmill based VO2 max testing.


Other Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 64
Study Start Date: July 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Lean Trained
Experimental: Obese or Overweight
Running Program Yoga Program
Behavioral: Running Program Behavioral: Yoga Program

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02150889

Contacts
Contact: Lisa S. Chow, MD 612-301-3979 endores@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02150889     History of Changes
Other Study ID Numbers: 1209M20741
Study First Received: May 22, 2014
Last Updated: July 30, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014