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

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT01901978

Collaborator

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

Enrollment

Location

Arm

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Insulin Resistance	Behavioral: Caloric restrictive diet	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Weight Loss Caloric restrictive diet	Behavioral: Caloric restrictive diet Patients will meet weekly with a registered dietician.

Arm

Intervention/Treatment

Experimental: Weight Loss

Caloric restrictive diet

Behavioral: Caloric restrictive diet

Patients will meet weekly with a registered dietician.

Outcome Measures

Primary Outcome Measures

Abdominal fat re-distribution with weight loss [12 weeks]
To assess in young women, the effects of weight loss on abdominal fat distribution.

Secondary Outcome Measures

Adipocyte cell size distrubtion and gene expression [12 week]
With 10% weight loss, assess changes in cell size distribution and gene expression of adipocytes from the subcutaneous adipose depot.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 32 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.