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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901978
• Other study ID #: 1007007067
• Secondary ID: R01HD040787
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: August 2018

Study information

• Verified date: February 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2018
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 32 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Weight Loss

Intervention

Behavioral:
• Caloric restrictive diet
Patients will meet weekly with a registered dietician.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal fat re-distribution with weight loss	To assess in young women, the effects of weight loss on abdominal fat distribution.	12 weeks
Secondary	Adipocyte cell size distrubtion and gene expression	With 10% weight loss, assess changes in cell size distribution and gene expression of adipocytes from the subcutaneous adipose depot.	12 week