Overweight and ObesityNCT03530111
Establishment of the 2H-labeling Protocol at Pennington Biomedical Research Center
An observational study of Overweight and Obesity and Exercise, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
A method has been developed to measure in vivo adipose kinetics and turnover rates, which is a substantive departure from previous indirect and in vitro approaches. This technique involves drinking deuterium (2H)-labeled water, with an initial ramp-up to increase body water 2H enrichment, followed by daily intake to… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Exercise
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2018to 28 Feb 2020
- Phase
- Observational
- 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
- Women only
- Healthy volunteers accepted
- Adult
Study population: 12 women who are overweight and are either sedentary or very physically active will be enrolled in the study.
Who may be able to join
- Pre-menopausal women
- 18-40 years of age
- BMI 25-29.9 kg/m2 (+/- 0.5 will be accepted)
- Are willing to drink deuterium-labeled water (2H2O) for 6 weeks
- Must be willing to comply with all study procedures, including adipose biopsies and a DXA scan
- If applicable, hormonal contraception must have been started at least 2 months before entering the study. If enrolled, subject must also agree to not alter hormonal birth control method, dose, or regimen throughout the duration of the study
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- If not using pharmaceutical (hormonal) contraception (i.e. birth control pills, vaginal ring, injections, or implant), agree to use a double barrier method as a form of birth control to prevent pregnancy
- Must be classified as either sedentary (achieve < 75 minutes of moderate-intensity or < 37 minutes of vigorous-intensity aerobic physical activity per week) or very physically active (achieve > 225 minutes of moderate-intensity or > 112 minutes of vigorous-intensity aerobic physical activity per week). Simple questions to assess physical activity level will be administered during the phone screening as well as the clinic screening visit.
- If enrolled, agree to not alter dose, level, or regimen of physical activity throughout the duration of the study
Who cannot join
- Unstable weight in the last 3 months (gain or loss >7 lb (3.2 kg)
- Significant changes in the diet or level of physical activity within the past month
- History of clinically diagnosed diabetes or a fasting blood glucose > 110 mg/dL
- An average screening blood pressure >140/90
- Have major organ disease (i.e. heart, kidney, lung, thyroid, or liver) or abnormal liver enzymes that are, in the opinion of the medical investigator, clinically significant and represent a problem for study inclusion.
- Self-reported positive test for human immunodeficiency virus, hepatitis B and hepatitis C
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- Chronic use of systemic glucocorticoids, systemic adrenergic-stimulating agents, anti-psychotic/anti-depressant medications, thiazolidinediones and other medications that may cause clinically significant weight gain or loss
- Chronic use of prescription or over-the-counter weight loss medications which, in the opinion of the MI, will impact the study.
- Smoking or use of tobacco products in the last 3 months
- Pregnancy, breastfeeding, or planned pregnancy for the upcoming 2 months
- Previous bariatric or other surgeries for obesity
- Diagnosed psychotic conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Establishment of the 2H-labeling Protocol to Assess in Vivo Adipose Tissue Dynamics at PBRC
A method has been developed to measure in vivo adipose kinetics and turnover rates, which is a substantive departure from previous indirect and in vitro approaches. This technique involves drinking deuterium (2H)-labeled water, with an initial ramp-up to increase body water 2H enrichment, followed by daily intake to maintain enrichment values. The 2H from the heavy water is incorporated into the DNA of the dividing cells, as well as the lipid component, providing measures of cell formation, lipid synthesis, and adipose turnover. The objective of the proposed study is to enroll women who are overweight (sedentary or physically active) in order to collect 2H-enriched adipose tissue specimens that will be utilized to establish this innovative 2H-labeling protocol at Pennington Biomedical Research Center. This study will also assess adipose kinetics in individuals with different levels of physical activity to better understand the association between in vivo adipose cell kinetics, physical activity, and metabolic health in humans.
- Conditions
- Overweight and Obesity, Exercise
- Keywords
- Adipose tissue, Adipose turnover, Adipose kinetics, Exercise, Deuterium
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sedentary | Sedentary individuals will be classified as achieving < 75 minutes of moderate-intensity or < 37 minutes of vigorous-intensity aerobic physical activity per week. | |
| Very Physically Active | Very Physically Active individuals will be classified as achieving > 225 minutes of moderate-intensity or > 112 minutes of vigorous-intensity aerobic physical activity per week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures (fractional synthesis) of In vivo Adipose Cell Formation
Following the consumption of deuterium-labeled water (2H2O; heavy water), adipose tissue biopsies from the subcutaneous abdominal and femoral depots will be collected. The 2H from the heavy water is enriched into the DNA of newly synthesized cells. Measures of DNA synthesis (obtained via gas chromatography and mass spectrometry analysis of 2H-enrichment) denote new adipose cell formation. The primary outcome is to assess adipose cell kinetic rates (i.e. synthesis) in sedentary and very physically active women.
Measured: 1 year
Secondary outcomes (1)
Measures (fractional synthesis) of In vivo Triglyceride Synthesis
Following the consumption of deuterium-labeled water (2H2O; heavy water), adipose tissue biopsies from the subcutaneous abdominal and femoral depots will be collected. The 2H from the heavy water is incorporated into the glycerol component of the adipose, providing a measure of new triglyceride synthesis. The secondary outcome is to assess adipose lipid (triglyceride) kinetic rates (i.e. synthesis) in sedentary and very physically active women.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start20 Jun 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ursula White, Pennington Biomedical Research Center
- Investigators
- Ursula White, Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530111
- Sponsor's protocol ID
- PBRC 2018-004
- Status last verified
- May 2020
- First submitted
- 2 May 2018
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of the 2H-labeling Protocol to Assess in Vivo Adipose Tissue Dynamics at PBRC
- ClinicalTrials.gov ID
- NCT03530111
- Acronym / sponsor ID
- PBRC 2018-004
- Conditions
- Overweight and Obesity, Exercise
- Keywords
- Adipose tissue, Adipose turnover, Adipose kinetics, Exercise, Deuterium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 21 May 2018 (actual)
- 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.
A method has been developed to measure in vivo adipose kinetics and turnover rates, which is a substantive departure from previous indirect and in vitro approaches. This technique involves drinking deuterium (2H)-labeled water, with an initial ramp-up to increase body water 2H enrichment, followed by daily intake to maintain enrichment values. The 2H from the heavy water is incorporated into the DNA of the dividing cells, as well as the lipid component, providing measures of cell formation, lipid synthesis, and adipose turnover. The objective of the proposed study is to enroll women who are overweight (sedentary or physically active) in order to collect 2H-enriched adipose tissue specimens that will be utilized to establish this innovative 2H-labeling protocol at Pennington Biomedical Research Center. This study will also assess adipose kinetics in individuals with different levels of physical activity to better understand the association between in vivo adipose cell kinetics, physical activity, and metabolic health in humans.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentary | – | –Sedentary individuals will be classified as achieving < 75 minutes of moderate-intensity or < 37 minutes of vigorous-intensity aerobic physical activity per week. |
| Very Physically Active | – | –Very Physically Active individuals will be classified as achieving > 225 minutes of moderate-intensity or > 112 minutes of vigorous-intensity aerobic physical activity per week. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 12 women who are overweight and are either sedentary or very physically active will be enrolled in the study.
Key inclusion criteria (9 listed)
- Pre-menopausal women
- 18-40 years of age
- BMI 25-29.9 kg/m2 (+/- 0.5 will be accepted)
- Are willing to drink deuterium-labeled water (2H2O) for 6 weeks
- Must be willing to comply with all study procedures, including adipose biopsies and a DXA scan
Key exclusion criteria (12 listed)
- Unstable weight in the last 3 months (gain or loss >7 lb (3.2 kg)
- Significant changes in the diet or level of physical activity within the past month
- History of clinically diagnosed diabetes or a fasting blood glucose > 110 mg/dL
- An average screening blood pressure >140/90
- Have major organ disease (i.e. heart, kidney, lung, thyroid, or liver) or abnormal liver enzymes that are, in the opinion of the medical investigator, clinically significant and represent a problem for study inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measures (fractional synthesis) of In vivo Adipose Cell Formation
Time frame: 1 year
Following the consumption of deuterium-labeled water (2H2O; heavy water), adipose tissue biopsies from the subcutaneous abdominal and femoral depots will be collected. The 2H from the heavy water is enriched into the DNA of newly synthesized cells. Measures of DNA synthesis (obtained via gas chromatography and mass spectrometry analysis of 2H-enrichment) denote new adipose cell formation. The primary outcome is to assess adipose cell kinetic rates (i.e. synthesis) in sedentary and very physically active women.
1 secondary outcome
Measures (fractional synthesis) of In vivo Triglyceride Synthesis
Time frame: 1 year
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 26 May 2020.
- 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.
Ursula White, Ph.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity and Exercise, run by Pennington Biomedical Research Center 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 9 inclusion and 12 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 26 May 2020. 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?
Measures (fractional synthesis) of In vivo Adipose Cell Formation (time frame: 1 year). 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 26 May 2020.