Fatty Acid Metabolism and Insulin Sensitivity After Exercise in Obesity

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
JEFFREY F HOROWITZ, University of Michigan
ClinicalTrials.gov Identifier:
NCT01451957
First received: October 11, 2011
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

Alterations in fatty acid mobilization and oxidation may be primary adaptations responsible for the improvements in metabolic health after a single session of endurance exercise. The investigators will determine the effect of a single session of endurance exercise on whole-body fatty acid mobilization and oxidation, IMTG concentration and the expression of factors that regulate these processes in skeletal muscle of 11 women with abdominal obesity (age: 18-45y). In addition, the investigators will evaluate how these factors, and exercise, effect insulin signalling and insulin sensitivity. Every effort will be made to recruit subjects from ethnic and minority groups. Before participating in the study, subjects will be informed of all the procedures and potential risks, and they will sign an informed consent form approved by The University of Michigan Institutional Review Board. Eligible volunteers will participate in three separate trials, in a randomized order. In two trials subjects will eat exactly the same amount of calories, except in one trial they will exercise (eucaloric + exercise) and in the other trial they will remain sedentary (hypercaloric). In a third trial subjects will again remain sedentary but instead they will ingest appropriate calories to maintain caloric balance (eucaloric + sedentary). By doing this the investigators are also able to investigate the effect of acute caloric perturbations on insulin sensitivity, because it is possible that the enhanced insulin sensitivity evident after exercise, as compared to the sedentary state, is due to caloric deficit and not the exercise bout, per se.


Condition Intervention
Obesity
Other: Exercise - caloric balance
Other: No Exercise - hyper-caloric diet
Other: No exercise - caloric balance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Fatty Acid Metabolism and Insulin Sensitivity After Exercise in Obesity

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    frequently sampled intravenous glucose tolerance test(FSIVGTT)will be done to assess insuiln sensitivity


Enrollment: 7
Study Start Date: August 2003
Estimated Study Completion Date: October 2013
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise
90 min exercise on Day 1
Other: Exercise - caloric balance
90 min exercise on Day 1 with meals afterward resulting in caloric balance for the day (i.e.; extra kcals provided to account for energy expended during exercise)]
Experimental: Sedentary Control
Subjects remain sedentary on Day 1 and will either consume a hyper-caloric or a caloric balanced diet
Other: No Exercise - hyper-caloric diet
Subjects remain sedentary on Day 1 and they ingest meals that are identical to those ingested on the day they performed exercise (i.e.; more calories ingested than expended because no exercise performed).
Other: No exercise - caloric balance
Subjects remain sedentary on Day 1 and they ingest a similar proportion of macronutrients however, the total calories ingested will be lower than the other two trials, resulting in caloric balance for the day.

  Eligibility

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

Inclusion Criteria:

  • Premenopausal; Body mass index 30-40 kg/m2; Waist circumference >88 cm

Exclusion Criteria:

  • Evidence of metabolic or cardiovascular disease; Pregnancy; Hyperlipidemia (fasting plasma triglyceride concentration > 150 mg/dl); Hematocrit < 34%; Undertaking regular exercise (i.e., >2 times/week)
  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: NCT01451957

Locations
United States, Michigan
Michigan Clincal Research Unit
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Jeffrey F Horowitz, Ph.D. University of Michigan
  More Information

No publications provided

Responsible Party: JEFFREY F HOROWITZ, Associate Professor, Movement Science, School of Kinesiology, University of Michigan
ClinicalTrials.gov Identifier: NCT01451957     History of Changes
Other Study ID Numbers: 03-0165
Study First Received: October 11, 2011
Last Updated: December 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
exercise
fatty acid metabolism
insulin sensitivity

Additional relevant MeSH terms:
Obesity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014