We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Progressive Metabolic Adaptations to Low Intensity Exercise Training and Weight Loss

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01452074
First Posted: October 14, 2011
Last Update Posted: May 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Jeffrey F Horowitz, University of Michigan
  Purpose

the investigators first aim is to determine the effect of low intensity exercise (without weight loss) on insulin sensitivity, muscle lipid metabolism, and factors regulating these processes in skeletal muscle after 1 day, 2 wks, 12 wks of training, and again after 3 days without exercise in obese adults. the investigators second aim is to determine the effect of combining low intensity exercise training with 10% weight loss on insulin sensitivity, muscle lipid metabolism, and factors regulating these processes in skeletal muscle.

Although a single 40 minute session of exercise at a low exercise intensity will not improve insulin sensitivity, the investigators anticipate adaptations after two weeks of exercise training (6 session/wk; 12 session total) will improve insulin sensitivity and be accompanied by a reduction in fatty acid intermediates and a reduction in markers for pro-inflammatory activation in muscle. the investigators anticipate changes in insulin sensitivity, fatty acid partitioning, and pro-inflammatory markers the day after the last session of a 12 wk training program (without weight-loss) will be similar to that measured after 2 weeks of training. the investigators anticipate insulin sensitivity, accumulation of fatty acid intermediates, and pro-inflammatory activation will be markedly improved after 10% weight loss when measured the day after exercise. the investigators would expect the improvements in Insulin sensitivity, accumulation of fatty acid intermediates, and markers of inflammatory stress will be significantly attenuated when measured 3 days after the most recent exercise session, but beneficial effects of 10% weight loss on these metabolic endpoints will persist when compared with before weight loss.


Condition Intervention
Obesity Other: Exercise Training Other: Weight Loss with continued Exercise Training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Jeffrey F Horowitz, University of Michigan:

Primary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: 2-3 hours ]
    A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity


Secondary Outcome Measures:
  • Resting Metabolic Rate [ Time Frame: 20-30 min ]
  • Meal Tolerance Test [ Time Frame: 2-3h ]

Estimated Enrollment: 16
Study Start Date: July 2011
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Exercise Training with Weight Loss

During the first 12 weeks of the study, subjects will adhere to an exercise training program while maintaining their original body weight. The exercise training program will entail the following: 40min/session, ~50% of their maximal aerobic capacity (approximately 100-110 beats per min), 5-6 days/week

After the first 12 weeks in the study, subjects will continue with the same exercise program, but then they will be placed on a reduced calorie diet until they lose exactly 10% of their original body weight

Other: Exercise Training
During the first 12 weeks of the study, subjects will adhere to an exercise training program while maintaining their original body weight. The exercise training program will entail the following: 40min/session, ~50% of their maximal aerobic capacity (approximately 100-110 beats per min), 5-6 days/week
Other: Weight Loss with continued Exercise Training
After the first 12 weeks in the study, subjects will continue with the same exercise program, but then they will be placed on a reduced calorie diet until they lose exactly 10% of their original body weight

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • body mass index [BMI]: 30-45 kg/m2; All women must be pre-menopausal; Non-exerciser (no regularly planned exercise/physical activity)

Exclusion Criteria:

  • Hematocrit ≤ 34%; Fasting plasma glucose concentration ≥ 125 mg/dL; Weight instability ≥ ±5 lbs in past month; Taking medications known to affect lipid and/or glucose metabolism; evidence and/or history of cardiovascular or frank metabolic diseases; pregnancy or actively breast feeding
  Contacts and Locations
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): NCT01452074


Locations
United States, Michigan
Michigan Clincal Research Unit
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Jeffrey F Horowitz University of Michigan
  More Information

Responsible Party: Jeffrey F Horowitz, Associate Professor, Movement Science, School of Kinesiology, University of Michigan
ClinicalTrials.gov Identifier: NCT01452074     History of Changes
Other Study ID Numbers: R01 DK077966 - PA
R01DK077966 ( U.S. NIH Grant/Contract )
First Submitted: October 11, 2011
First Posted: October 14, 2011
Last Update Posted: May 1, 2017
Last Verified: April 2017

Keywords provided by Jeffrey F Horowitz, University of Michigan:
Insulin Sensitivity
Exercise Training
Weight Loss
Fat Metabolism