Glucose and Lipid Metabolism in Adolescents

June 6, 2011 updated by: National Institutes of Health (NIH)
A 12 wk aerobic exercise program will reduce visceral, hepatic and intramyocellular fat accumulation and improve insulin sensitivity and glucose metabolism in obese sedentary Hispanic adolescents.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Lean and Obese post pubertal adolescents perform an aerobic exercise program 30 minx4/week at a heart rate corresponding to at least 70% of that obtained at VO2 peak. The exercise program is preceded and followed by a 7 d diet delivered by the metabolic research kitchen (identical on both study occasions); metabolic studies (identical on both study occasions) including 24h calorimetry, measurements of glucose and lipid metabolism and insulin sensitivity and secretion using compounds labelled with stable i.e. non radioactive isotopes and gas chromatography-mass spectrometry.Fat mass and lean body mass are measured by DXA and visceral/subcutaneous, hepatic and intramyocellular fat by MRI/MRS. Since we want to specifically determine the effects of exercise, there is no intent of weight loss. The subjects are weighed twice a week to assure weight stability.

Study Type

Observational

Enrollment (Anticipated)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
        • Principal Investigator:
          • Agneta L Sunehag, M.D., Ph.D

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

13 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Sedentary, post pubertal, Hispanic lean and obese adolescents

Description

Inclusion Criteria:

  • Healthy
  • No medication
  • Sedentary
  • No first degree relative with diabetes,
  • Hispanic
  • BMI >30 or <25 kg/m2.

Exclusion Criteria:

  • Any medication including birth control pills
  • Performing more than >45 min of moderate to light physical activity/week
  • Chronic illness

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adolescents
Post pubertal, sedentary lean and obese Hispanic adolescents
Behavioral: Exercise
12 wk aerobic or/ resistance exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fat distribution, insulin sensitivity, glucose production, gluconeogenesis, glycogenolysis
Time Frame: In response to a 12 wk exercise program.
In response to a 12 wk exercise program.

Secondary Outcome Measures

Outcome Measure
Time Frame
Lipolysis, blood lipids, adiponectin, leptin and CRP
Time Frame: In response to a 12 wk exercise program
In response to a 12 wk exercise program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Agneta L Sunehag, M.D., Ph.D, Baylor College of Medicine

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

February 1, 2004

Primary Completion (ANTICIPATED)

December 1, 2011

Study Completion (ANTICIPATED)

December 1, 2011

Study Registration Dates

First Submitted

October 20, 2009

First Submitted That Met QC Criteria

October 20, 2009

First Posted (ESTIMATE)

October 21, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 7, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sunehagexercise
  • NIHNICHDRO1 HD044609

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.

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