NCT00704197

Brief Summary

The purpose of this study is to characterize differences in the structure and function of the body fat from two different parts of the body in young, healthy men and women. We will also compare how differences in metabolism relate to characteristics of body fat and its functions.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2008

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

6.3 years

First QC Date

June 20, 2008

Last Update Submit

September 13, 2022

Conditions

ObesityDiabetes

Outcome Measures

Primary Outcomes (1)

  • To assess sex differences in adipose tissue gene expression in different fat depots

    baseline

Secondary Outcomes (1)

  • To assess sex differences in other characteristics of adipose tissue structure and function in different fat depots across sex including: preadipocyte kinetics; lipolysis and lipogenesis; macrophage content; and tissue oxygenation

    baseline

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Residents of Baton Rouge

You may qualify if:

  • Diabetic men and women ages 40 to 60, inclusive and healthy men and women ages 20 to 35, inclusive.
  • Body mass index (a ratio of height to weight) less than 25 kg/m2 (lean group) or 27 to 35 kg/m2 (overweight/obese group).
  • Not involved in regular physical activity (more than 3 times per week).
  • Women must have regular menstrual cycles (1 menstrual bleeding each month).

You may not qualify if:

  • For men in the overweight/obese group, you have a waist circumference less than 102cm (40 inches).
  • You smoke.
  • You have liver, kidney, thyroid or heart diseases, or cancer.
  • You are claustrophobic.
  • You have metal objects in your body such as implanted rods or surgical clips.
  • If you are not diabetic and you are taking steroids, protease inhibitors, statins, antihypertensives or medications known to alter glucose or lipid metabolism.
  • If you are diabetic and you are taking steroids, protease inhibitors, or injectable antihyperglycemic medications (oral diabetic meds are allowed.)
  • If you are a woman, you are pregnant or breast feeding or trying to become pregnant (women who become pregnant throughout the study will be excluded).
  • If you are a woman, you are using hormonal contraceptives or have anovulation, androgen excess or irregular menstrual cycles (less than 1 cycle per month).
  • You have previously had a BMI \>35 kg/m2.
  • You are not able to eat the foods provided by PBRC.
  • If your weight has not been stable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (3)

  • Nunez Lopez YO, Garufi G, Pasarica M, Seyhan AA. Elevated and Correlated Expressions of miR-24, miR-30d, miR-146a, and SFRP-4 in Human Abdominal Adipose Tissue Play a Role in Adiposity and Insulin Resistance. Int J Endocrinol. 2018 Mar 12;2018:7351902. doi: 10.1155/2018/7351902. eCollection 2018.

    PMID: 29721017DERIVED

  • Divoux A, Xie H, Li JL, Karastergiou K, Perera RJ, Chang RJ, Fried SK, Smith SR. MicroRNA-196 Regulates HOX Gene Expression in Human Gluteal Adipose Tissue. Obesity (Silver Spring). 2017 Aug;25(8):1375-1383. doi: 10.1002/oby.21896. Epub 2017 Jun 25.

    PMID: 28649807DERIVED

  • Pasarica M, Rood J, Ravussin E, Schwarz JM, Smith SR, Redman LM. Reduced oxygenation in human obese adipose tissue is associated with impaired insulin suppression of lipolysis. J Clin Endocrinol Metab. 2010 Aug;95(8):4052-5. doi: 10.1210/jc.2009-2377. Epub 2010 May 13.

    PMID: 20466783DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, urine, adipose tissue

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Steven R Smith, M.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2008

First Posted

June 24, 2008

Study Start

August 1, 2007

Primary Completion

December 1, 2013

Study Completion

January 1, 2016

Last Updated

September 15, 2022

Record last verified: 2022-09

Locations

US(1)