Glucose and Lipid Metabolism in Adolescents

Obesity Clinical Trial

Official title:

Glucose and Lipid Metabolism in Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00998855
• Other study ID #: sunehagexercise
• Secondary ID: NIHNICHDRO1 HD04
• Status: Recruiting
• Phase: N/A
• First received: October 20, 2009
• Last updated: June 6, 2011
• Start date: February 2004
• Est. completion date: December 2011

Study information

• Verified date: October 2009
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: Agneta L Sunehag, M.D., Ph.D.
• Phone: 713 798 6725
• Email: asunehag[@]bcm.tmc.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Exercise
• Insulin Sensitivity
• Obesity

Intervention

Behavioral:
• Exercise
12 wk aerobic or/ resistance exercise program

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat distribution, insulin sensitivity, glucose production, gluconeogenesis, glycogenolysis		In response to a 12 wk exercise program.	No
Secondary	Lipolysis, blood lipids, adiponectin, leptin and CRP		In response to a 12 wk exercise program	No