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OpenTrials
Completed

NCT Number: NCT01188642

Effects of Physical Training and Nutrition Education on Adipocytokines in Severely Obese Teenagers

Obesity is now becoming significantly prevalent of an environment characterized by easily available calorics foods combined with sedentary lifestyles. Moreover, it has been demonstrated that obesity is associated with metabolic complications such as disturbed adipocytokines, hormones secreted by adipose tissue. Given these observations, the purpose of this study is to assess the effects of a lifestyle intervention focused on various physical activities and nutrition education on adipocytokines hormones, in severely obese teenagers.

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Key information

Conditions

Healthy Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire

Besançon, 25030, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • to be aged from 12 to 17
  • to have a body mass index > 97 percentile for age and gender

Exclusion criteria

  • systemic disease
  • endocrine disorder
  • syndromic obesity
  • subjects receiving medication with a history of recent intercurrent illness

Treatment and study plan

obesity lifestyle intervention

Behavioral

physical activity 5 times per week + nutrition education

Primary outcomes

  1. Adipocytokines (leptin, adiponectin, ghrelin, PAI-1, resistin), based on subject's arterialized capillary blood samples.

    Time frame: during a lifestyle intervention of 9 months

Secondary outcomes

  1. Body weight, body mass index, waist and hip circumference

    Time frame: during a lifestyle intervention of 9 months

  2. Body composition, calculated by a multifrequency bioelectric impedance

    Time frame: during a lifestyle intervention of 9 months

  3. Glycemia and lipids profile, based on subject's arterialized capillary blood samples analysis.

    Time frame: during a lifestyle intervention of 9 months

  4. Insulin resistance, calculated according to the formula of homeostasis model assessment

    Time frame: during a lifestyle intervention of 9 months

  5. Systolic and diastolic blood pressure, measured in millimeters of mercury at the level of the left brachial artery, using an automatic blood pressure monitor.

    Time frame: during a lifestyle intervention of 9 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: OBAPA

Important dates

Study start
2009
Primary completion
2009
First posted
Aug 25, 2010
Registry last updated
Aug 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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