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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


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
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