Overview

This trial is active, not recruiting.

Conditions obesity, insulin resistance
Treatment caloric restrictive diet
Sponsor Yale University
Collaborator National Institutes of Health (NIH)
Start date May 2011
End date July 2014
Trial size 40 participants
Trial identifier NCT01901978, 1007007067-Adipocyte Study, R01HD040787

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Caloric restrictive diet
caloric restrictive diet
Patients will meet weekly with a registered dietician.

Primary Outcomes

Measure
Abdominal fat re-distribution with weight loss
time frame: 12 weeks

Secondary Outcomes

Measure
Adipocyte cell size distrubtion and gene expression
time frame: 12 week

Eligibility Criteria

Female participants from 16 years up to 32 years old.

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.

Additional Information

Official title Study to Investigate Benefits of Weight Loss in Yound Adults and Adolescents
Principal investigator Sonia Caprio, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Yale University.