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

February 28, 2020 updated by: Yale University

Study to Investigate Benefits of Weight Loss in Yound 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 32 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

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

Investigators

  • Principal Investigator: Sonia Caprio, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

July 15, 2013

First Submitted That Met QC Criteria

July 15, 2013

First Posted (Estimate)

July 17, 2013

Study Record Updates

Last Update Posted (Actual)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 28, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1007007067
  • R01HD040787 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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