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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01901978

Enrollment

Registered

2013-07-17

Start date

2011-05-31

Completion date

2018-08-31

Last updated

2020-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Obesity

Keywords

Obesity, Insulin Resistance, Weight loss, Women

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.

Interventions

BEHAVIORALCaloric restrictive diet

Patients will meet weekly with a registered dietician.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 32 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Abdominal fat re-distribution with weight loss	12 weeks	To assess in young women, the effects of weight loss on abdominal fat distribution.

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026