Glucose and Lipid Metabolism in Adolescents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00998855
First received: October 20, 2009
Last updated: June 6, 2011
Last verified: October 2009
  Purpose

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.


Condition Intervention
Exercise
Obesity
Insulin Sensitivity
Behavioral: Exercise

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Glucose and Lipid Metabolism in Adolescents

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Fat distribution, insulin sensitivity, glucose production, gluconeogenesis, glycogenolysis [ Time Frame: In response to a 12 wk exercise program. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipolysis, blood lipids, adiponectin, leptin and CRP [ Time Frame: In response to a 12 wk exercise program ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: February 2004
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adolescents
Post pubertal, sedentary lean and obese Hispanic adolescents
Behavioral: Exercise
12 wk aerobic or/ resistance exercise program

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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Sedentary, post pubertal, Hispanic lean and obese adolescents

Criteria

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
  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: NCT00998855

Contacts
Contact: Agneta L Sunehag, M.D., Ph.D. 713 798 6725 asunehag@bcm.tmc.edu

Locations
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Agneta L Sunehag, M.D., Ph.D    713-798-6725    asunehag@bcm.tmc.edu   
Principal Investigator: Agneta L Sunehag, M.D., Ph.D         
Sponsors and Collaborators
Investigators
Principal Investigator: Agneta L Sunehag, M.D., Ph.D Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Agneta L Sunehag M.D., Ph.D., Baylor College of Medicine, Houston TX
ClinicalTrials.gov Identifier: NCT00998855     History of Changes
Other Study ID Numbers: sunehagexercise, NIHNICHDRO1 HD044609
Study First Received: October 20, 2009
Last Updated: June 6, 2011
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Exercise in obesity

Additional relevant MeSH terms:
Obesity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 29, 2014