ObesityNCT02703766
Weight Gain and Adipose Tissue
A study testing overfeeding induced weight gain in people with Obesity, run by Mayo Clinic at 2 sites in United States.
Trial summary
This study aims to examine the role of weight gain in adipose tissue immune cell influx and development of obesity related cardiometabolic disorders. Adipose tissue-mediated chronic systemic inflammation is implicated in the development of cardiometabolic disorders in obesity. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- overfeeding induced weight gain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2016to 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 40 (inclusive) years
- BMI 18.5 <30 kg/m2
- Gender: Both males and females will be allowed to participate in the study
- Predominantly sedentary
- Absence of any chronic medical conditions other than seasonal or environmental allergies
- On no prescription medications other than second generation antihistamines (cetirizine , Fexofenadine, Desloratadine, Loratadine, etc), oral contraceptive pills, or intrauterine devices
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- Not a current smoker or tobacco user
- Not pregnant or breast feeding and not intending to become pregnant or breast feed
- Lean (low body fat mass) (body fat content ≤ 25% for men, < 35% for women) n=7; Obese (high body fat mass) (body fat content >25% for men, ≥ 35% for women) n=7
- Ability to provide written informed consent
Who cannot join
- Vulnerable study population will be excluded
- Presence of chronic diseases such as diabetes, and cardiovascular disease
- Pregnancy
- Anemic (hemoglobin <13.5 g/dL for men and <12.0 g/dL for women)
- Postmenopausal
- Smoking
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- Use of chronic Medications (aspirin, statin, anti-inflammatory drugs)
- Subjects found to have significant sleep disorders will be excluded
- Dietary restrictions including lactose intolerance, and vegan diet
- Eating disorders that may interfere with weight gain and weight loss
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Pilot Study to Examine the Effects of Weight Gain on Adipose Tissue
This study aims to examine the role of weight gain in adipose tissue immune cell influx and development of obesity related cardiometabolic disorders. Adipose tissue-mediated chronic systemic inflammation is implicated in the development of cardiometabolic disorders in obesity. Therefore, resolution of adipose tissue inflammation may be key to ameliorating obesity-associated dyslipidemia, insulin-resistance, and cardiovascular disease. Proinflammatory cytokines contribute to the initial influx of immune cells into adipose tissue during weight gain. However, mechanisms regulating these cytokines in the adipose tissue milieu and the effects of weight gain on adipose tissue are not completely understood.
The study proposes to investigate the molecular events contributing to increased infiltration of macrophages and T-cells into adipose tissue during weight gain. The central hypothesis is that in lean subjects (with low body fat mass), healthy fat gain which is associated with decreased expression of proinflammatory cytokines. However, in obesity (high body fat mass), adipose tissue is altered, which permits increased expression of inflammatory cytokines and further fat gain results in influx of immune cells. To test the hypothesis, adipose tissue from well characterized lean (control, with low body fat) and obese individuals (with high body fat) at baseline and after a modest 5% weight gain will be used. Adipose tissue samples after subsequent weight loss will also be examined.
For this study, obesity will be defined by body composition rather than body mass index (BMI), as several studies have shown that BMI does not adequately define obesity and several individuals with normal BMI may indeed have high body fat mass. Individuals with body fat content ≤25% for men, \& <35% for women) will be considered lean and individuals with body fat content >25% for men, ≥35% for women will be considered obese.
- Conditions
- Obesity
- Being tested
- overfeeding induced weight gain
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
overfeeding induced weight gainBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Lean | Active comparator | Lean individuals are defined as having body fat content less or equal to 25% in men and less than 35% for women.
Overfeeding induced weight gain and subsequent weight loss Receives: Behavioral: overfeeding induced weight gain |
| Obese | Experimental | obese individuals are defined as having body fat content more than 25% in men and more than 35% for women.
Overfeeding induced weight gain and subsequent weight loss Receives: Behavioral: overfeeding induced weight gain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in adipose tissue inflammation by 8 week of modest weight gain followed by 8 week of weight loss.
Adipose tissue inflammation will be measures by RTPCR and Western Blot. These will be presented as ratio to endogenous house keeping gene.
Measured: 16-20 weeks
Secondary outcomes (1)
Change from baseline in blood pressure by 8 week of modest weight gain followed by 8 weeks of weight loss.
Measured: 16-20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virend Somers, Mayo Clinic
- Investigators
- Virend Somers, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703766
- Sponsor's protocol ID
- 15-007623
- Status last verified
- Jan 2019
- First submitted
- 5 Jan 2016
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Examine the Effects of Weight Gain on Adipose Tissue
- ClinicalTrials.gov ID
- NCT02703766
- Acronym / sponsor ID
- 15-007623
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 9 Mar 2016 (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.
This study aims to examine the role of weight gain in adipose tissue immune cell influx and development of obesity related cardiometabolic disorders. Adipose tissue-mediated chronic systemic inflammation is implicated in the development of cardiometabolic disorders in obesity. Therefore, resolution of adipose tissue inflammation may be key to ameliorating obesity-associated dyslipidemia, insulin-resistance, and cardiovascular disease. Proinflammatory cytokines contribute to the initial influx of immune cells into adipose tissue during weight gain. However, mechanisms regulating these cytokines in the adipose tissue milieu and the effects of weight gain on adipose tissue are not completely understood.
The study proposes to investigate the molecular events contributing to increased infiltration of macrophages and T-cells into adipose tissue during weight gain. The central hypothesis is that in lean subjects (with low body fat mass), healthy fat gain which is associated with decreased expression of proinflammatory cytokines. However, in obesity (high body fat mass), adipose tissue is altered, which permits increased expression of inflammatory cytokines and further fat gain results in influx of immune cells. To test the hypothesis, adipose tissue from well characterized lean (control, with low body fat) and obese individuals (with high body fat) at baseline and after a modest 5% weight gain will be used. Adipose tissue samples after subsequent weight loss will also be examined.
For this study, obesity will be defined by body composition rather than body mass index (BMI), as several studies have shown that BMI does not adequately define obesity and several individuals with normal BMI may indeed have high body fat mass. Individuals with body fat content ≤25% for men, \& <35% for women) will be considered lean and individuals with body fat content >25% for men, ≥35% for women will be considered obese.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean | Active comparator | Behavioral: overfeeding induced weight gainLean individuals are defined as having body fat content less or equal to 25% in men and less than 35% for women. Overfeeding induced weight gain and subsequent weight loss |
| Obese | Experimental | Behavioral: overfeeding induced weight gainobese individuals are defined as having body fat content more than 25% in men and more than 35% for women. Overfeeding induced weight gain and subsequent weight loss |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age: 18 to 40 (inclusive) years
- BMI 18.5 <30 kg/m2
- Gender: Both males and females will be allowed to participate in the study
- Predominantly sedentary
- Absence of any chronic medical conditions other than seasonal or environmental allergies
Key exclusion criteria (10 listed)
- Vulnerable study population will be excluded
- Presence of chronic diseases such as diabetes, and cardiovascular disease
- Pregnancy
- Anemic (hemoglobin <13.5 g/dL for men and <12.0 g/dL for women)
- Postmenopausal
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 |
|---|---|---|
| overfeeding induced weight gain | Behavioural | Lean, Obese |
Primary outcome
Change from baseline in adipose tissue inflammation by 8 week of modest weight gain followed by 8 week of weight loss.
Time frame: 16-20 weeks
Adipose tissue inflammation will be measures by RTPCR and Western Blot. These will be presented as ratio to endogenous house keeping gene.
1 secondary outcome
Change from baseline in blood pressure by 8 week of modest weight gain followed by 8 weeks of weight loss.
Time frame: 16-20 weeks
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 9 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
Virend Somers, MD, PhD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing overfeeding induced weight gain in people with Obesity, run by Mayo Clinic at 2 sites 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 10 inclusion and 10 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 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 from baseline in adipose tissue inflammation by 8 week of modest weight gain followed by 8 week of weight loss. (time frame: 16-20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2019.