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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02456870
Other study ID # 14-2411
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date December 2018

Study information

Verified date June 2019
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 2018
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Overfeeding
Consumption of 40% excess calories for 7 consecutive days

Locations

Country Name City State
United States Univeristy of Colorado, Anschutz Medical Campus Aurora Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver Colorado State University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in adipose-derived stem cell (ASC) differentiation (Delta%oil red O+) age-related difference in the ASC differentiation response to overfeeding 1 wk of overfeeding
Secondary Change in ASC proliferation (Delta rate of cell growth) age-related difference in the ASC proliferative response to overfeeding 1 wk of overfeeding
Secondary Change in expression of C/EBPalpha, C/EBPbeta, PPARgamma2, SREBP1c, SREBf1a, and Wnt10b (fold-changes in mRNA expression) age-related difference in the pro-adipogenic response to overfeeding 1 wk overfeeding
Secondary Change in intramyocellular (IMCL) di-saturated diacylglycerol (DAG) localization (Delta %membrane:cytosol) age-related difference in the IMCL DAG response to overfeeding 1 week overfeeding
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