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

Primary Purpose

Obesity, Insulin Resistance

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Caloric restrictive diet

About this trial

This is an interventional health services research trial for Obesity focused on measuring Obesity, Insulin Resistance, Weight loss, Women

Eligibility Criteria

16 Years - 32 Years (Child, Adult)FemaleDoes not accept 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.

Sites / Locations

Yale University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Weight Loss

Arm Description

Caloric restrictive diet

Outcomes

Primary Outcome Measures

Abdominal fat re-distribution with weight loss

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01901978

First Posted

July 15, 2013

Last Updated

February 28, 2020

Sponsor

Yale University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01901978

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

May 2011 (Actual)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

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

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Insulin Resistance

Keywords

Obesity, Insulin Resistance, Weight loss, Women

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Weight Loss

Arm Type

Experimental

Arm Description

Caloric restrictive diet

Intervention Type

Behavioral

Intervention Name(s)

Caloric restrictive diet

Intervention Description

Patients will meet weekly with a registered dietician.

Primary Outcome Measure Information:

Title

Abdominal fat re-distribution with weight loss

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Adipocyte cell size distrubtion and gene expression

Description

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

Time Frame

12 week

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

32 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sonia Caprio, MD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD will not be shared with other researchers. Only group data that is used in data analysis for manuscripts will be shared and that is de-identified.

Learn more about this trial

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

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