AgingEATNCT02456870
Expandability of Aging Adipose Tissue
A study testing Overfeeding in people with Aging and Obesity, run by University of Colorado, Denver at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 25 to 75 years, men onlyHealthy volunteers can take part
- What is being tested?
- Overfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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.
- Being tested
- Overfeeding
- Keywords
- Adipose tissue, Overfeeding
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OverfeedingOther
Consumption of 40% excess calories for 7 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| MA | Other | Middle-aged overweight and obese men (age 25-40yr) Receives: Other: Overfeeding |
| OA | Other | Older overweight and obese men (age 55-75yr) Receives: Other: Overfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adipose-derived stem cell (ASC) differentiation (Delta%oil red O+)
age-related difference in the ASC differentiation response to overfeeding
Measured: 1 wk of overfeeding
Secondary outcomes (3)
Change in ASC proliferation (Delta rate of cell growth)
age-related difference in the ASC proliferative response to overfeeding
Measured: 1 wk of overfeeding
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
Measured: 1 wk overfeeding
Change in intramyocellular (IMCL) di-saturated diacylglycerol (DAG) localization (Delta %membrane:cytosol)
age-related difference in the IMCL DAG response to overfeeding
Measured: 1 week overfeeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado State University
- Responsible party
- Sponsor
- Investigators
- Rachael E Van Pelt, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456870
- Sponsor's protocol ID
- 14-2411
- Acronym
- EAT
- Status last verified
- Jun 2019
- First submitted
- 8 Apr 2015
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17717599Caso 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.
PubMed 22999012Tchoukalova 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.
PubMed 20921416
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging Subcutaneous Adipose Tissue Response to Overfeeding
- ClinicalTrials.gov ID
- NCT02456870
- Acronym / sponsor ID
- EAT / 14-2411
- Keywords
- Adipose tissue, Overfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Colorado State University
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MA | Other | Other: OverfeedingMiddle-aged overweight and obese men (age 25-40yr) |
| OA | Other | Other: OverfeedingOlder overweight and obese men (age 55-75yr) |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OverfeedingConsumption of 40% excess calories for 7 consecutive days | Other | MA, OA |
Primary outcome
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
3 secondary outcomes
Change in ASC proliferation (Delta rate of cell growth)
Time frame: 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
Change in intramyocellular (IMCL) di-saturated diacylglycerol (DAG) localization (Delta %membrane:cytosol)
Time frame: 1 week overfeeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Background: PubMed 17717599Kim 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.
- Background: PubMed 22999012Caso 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.
- Background: PubMed 20921416Tchoukalova 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachael E Van Pelt, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overfeeding in people with Aging and Obesity, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adipose-derived stem cell (ASC) differentiation (Delta%oil red O+) (time frame: 1 wk of overfeeding). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02456870, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.