- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02456870
Expandability of Aging Adipose Tissue (EAT)
June 11, 2019 updated by: University of Colorado, Denver
Aging Subcutaneous Adipose Tissue Response to Overfeeding
The purpose of this pilot study is to determine whether adipose tissue loses some of its ability to expand in response to overfeeding in older compared to younger men.
The investigators hypothesize that the adipose tissue response to overfeeding may be weakened in older when compared to younger men, thereby leading to worsened ectopic storage depots for older men.
Study Overview
Detailed Description
This pilot study will begin to address whether adipose tissue biology changes with advancing age.
Specifically, we will test whether adipose tissue loses some of its ability to expand in response to overfeeding in older compared to younger men.
To test this possibility the Investigators will recruit overweight and mildly obese older (age 55-75y) and younger (age 25-40y) men and collect adipose tissue biopsies before and after 7 days of overfeeding.
The investigators will test how well the cells in adipose tissue expand in response to overfeeding and whether this differs between younger and older men.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Univeristy of Colorado, Anschutz Medical Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Men
- Aged 25-40y OR 55-75y
- BMI 28-35 kg/m2
- Weight stable (±2kg over past 3 mo)
- Sedentary to moderately active (<3 d/wk of exercise lasting >20min)
- Non-smokers (never used or quit >7yrs prior)
Exclusion Criteria:
- Women
- Currently using hormones, glucose or lipid lowering medication
- Engaged in exercise or diet program
- Currently gaining or losing weight or using weight loss drugs
- Diabetes mellitus (diagnosis, treatment, FBG ≥126 mg/dL)
- Uncontrolled metabolic disorders (e.g., thyroid)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: MA
Middle-aged overweight and obese men (age 25-40yr)
|
Consumption of 40% excess calories for 7 consecutive days
|
OTHER: OA
Older overweight and obese men (age 55-75yr)
|
Consumption of 40% excess calories for 7 consecutive days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in adipose-derived stem cell (ASC) differentiation (Delta%oil red O+)
Time Frame: 1 wk of overfeeding
|
age-related difference in the ASC differentiation response to overfeeding
|
1 wk of overfeeding
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in ASC proliferation (Delta rate of cell growth)
Time Frame: 1 wk of overfeeding
|
age-related difference in the ASC proliferative response to overfeeding
|
1 wk of overfeeding
|
Change in expression of C/EBPalpha, C/EBPbeta, PPARgamma2, SREBP1c, SREBf1a, and Wnt10b (fold-changes in mRNA expression)
Time Frame: 1 wk overfeeding
|
age-related difference in the pro-adipogenic response to overfeeding
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1 wk overfeeding
|
Change in intramyocellular (IMCL) di-saturated diacylglycerol (DAG) localization (Delta %membrane:cytosol)
Time Frame: 1 week overfeeding
|
age-related difference in the IMCL DAG response to overfeeding
|
1 week overfeeding
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tchoukalova YD, Votruba SB, Tchkonia T, Giorgadze N, Kirkland JL, Jensen MD. Regional differences in cellular mechanisms of adipose tissue gain with overfeeding. Proc Natl Acad Sci U S A. 2010 Oct 19;107(42):18226-31. doi: 10.1073/pnas.1005259107. Epub 2010 Oct 4.
- Kim JY, van de Wall E, Laplante M, Azzara A, Trujillo ME, Hofmann SM, Schraw T, Durand JL, Li H, Li G, Jelicks LA, Mehler MF, Hui DY, Deshaies Y, Shulman GI, Schwartz GJ, Scherer PE. Obesity-associated improvements in metabolic profile through expansion of adipose tissue. J Clin Invest. 2007 Sep;117(9):2621-37. doi: 10.1172/JCI31021.
- Caso G, McNurlan MA, Mileva I, Zemlyak A, Mynarcik DC, Gelato MC. Peripheral fat loss and decline in adipogenesis in older humans. Metabolism. 2013 Mar;62(3):337-40. doi: 10.1016/j.metabol.2012.08.007. Epub 2012 Sep 19.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (ACTUAL)
December 1, 2016
Study Completion (ACTUAL)
December 1, 2018
Study Registration Dates
First Submitted
April 8, 2015
First Submitted That Met QC Criteria
May 26, 2015
First Posted (ESTIMATE)
May 29, 2015
Study Record Updates
Last Update Posted (ACTUAL)
June 13, 2019
Last Update Submitted That Met QC Criteria
June 11, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14-2411
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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