NCT01901978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

3.2 years

First QC Date

July 15, 2013

Last Update Submit

February 28, 2020

Conditions

ObesityInsulin Resistance

Keywords

ObesityInsulin ResistanceWeight lossWomen

Outcome Measures

Primary Outcomes (1)

  • Abdominal fat re-distribution with weight loss

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

    12 weeks

Secondary Outcomes (1)

  • Adipocyte cell size distrubtion and gene expression

    12 week

Study Arms (1)

Weight Loss

EXPERIMENTAL

Caloric restrictive diet

Behavioral: Caloric restrictive diet

Interventions

Caloric restrictive dietBEHAVIORAL

Patients will meet weekly with a registered dietician.

Weight Loss

Eligibility Criteria

Age16 Years - 32 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women ages 16-32

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

ObesityInsulin ResistanceWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBody Weight Changes

Study Officials

  • Sonia Caprio, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2013

First Posted

July 17, 2013

Study Start

May 1, 2011

Primary Completion

July 1, 2014

Study Completion

August 1, 2018

Last Updated

March 2, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)