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

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Yale University

Status

Completed

Conditions

Insulin Resistance
Obesity

Treatments

Behavioral: Caloric restrictive diet

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01901978
R01HD040787 (U.S. NIH Grant/Contract)
1007007067

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

Female

Ages

16 to 32 years old

Volunteers

No 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.

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

Weight Loss
Experimental group
Description:
Caloric restrictive diet
Treatment:
Behavioral: Caloric restrictive diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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