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NCT Number: NCT01901978

Study to Investigate Benefits of Weight Loss in Young Adults and Adolescents

The purpose of this study is to investigate the changes in subcutaneous adipocyte size, number and gene expression after weight loss and to assess whether those changes contribute to decreases in ectopic fat accumulation and insulin resistance in women between ages of 16-32.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

16 year–32 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06520, United States

About this study

There are no studies in young women that have prospectively studied changes in fat cell size, gene expression and insulin sensitivity during the transition from overweight/obese to normal weight. Our preliminary data suggest that the presence of ectopic fat accumulation and insulin resistance in obese children could be considered an "early phase" in the development of T2DM. We hypothesize that a 10% weight loss will restore/improve insulin sensitivity. Furthermore, we speculate that the decrease in subcutaneous fat mass after weight loss is due to a decrease in mean adipocyte cell size, but not cell number.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women ages 16-32

Exclusion criteria

  • They will not be on any medications that are known to alter glucose or insulin metabolism, such as oral steroids, or certain psychiatric medications, such as Xeleca, Lithium and Paxil. Patients on diuretics will be excluded.

Treatment and study plan

Caloric restrictive diet

Behavioral

Patients will meet weekly with a registered dietician.

Primary outcomes

  1. Abdominal fat re-distribution with weight loss

    Time frame: 12 weeks

    To assess in young women, the effects of weight loss on abdominal fat distribution.

Secondary outcomes

  1. Adipocyte cell size distrubtion and gene expression

    Time frame: 12 week

    With 10% weight loss, assess changes in cell size distribution and gene expression of adipocytes from the subcutaneous adipose depot.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)

Registry information

Official study title

Study to Investigate Benefits of Weight Loss in Yound Adults and Adolescents

Important dates

Study start
2011
Primary completion
2014
Study completion
2018
First posted
Jul 17, 2013
Registry last updated
Mar 2, 2020

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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