- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01451957
Fatty Acid Metabolism and Insulin Sensitivity After Exercise in Obesity
November 22, 2016 updated by: Jeffrey F Horowitz, University of Michigan
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Michigan Clincal Research Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise
90 min exercise on Day 1
|
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
|
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).
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin Sensitivity
Time Frame: 3 hours
|
frequently sampled intravenous glucose tolerance test(FSIVGTT)will be done to assess insuiln sensitivity
|
3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeffrey F Horowitz, Ph.D., University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2003
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
October 11, 2011
First Submitted That Met QC Criteria
October 13, 2011
First Posted (Estimate)
October 14, 2011
Study Record Updates
Last Update Posted (Estimate)
November 23, 2016
Last Update Submitted That Met QC Criteria
November 22, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-0165
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Exercise - caloric balance
-
University of AarhusUniversity of Copenhagen; University of Southern DenmarkCompletedDiet; Deficiency | Exercise InterventionDenmark
-
University of VermontCompleted
-
Sun Yat-sen UniversityCompletedWeight Loss | Cardiometabolic Risk | Intestinal Microbiome | Immune SystemChina
-
National Institute on Aging (NIA)CompletedCardiovascular Disease | Diabetes Mellitus | AgingUnited States
-
National Institute on Aging (NIA)Completed
-
Taipei Medical UniversityCompletedExercise | Training | Elderly | Balance | Visual Dependence | MultisensoryTaiwan
-
Vanderbilt UniversityUniversity of WashingtonCompleted
-
University of PadovaCompleted
-
Cairo UniversityUnknownPolycystic Ovary Syndrome | Irregular MensesEgypt
-
Wake Forest University Health SciencesNational Institute on Aging (NIA)CompletedMetabolic Syndrome | Abdominal ObesityUnited States