- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03530111
Establishment of the 2H-labeling Protocol at Pennington Biomedical Research Center
May 22, 2020 updated by: Ursula White, Pennington Biomedical Research Center
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
11
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
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
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
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
12 women who are overweight and are either sedentary or very physically active will be enrolled in the study.
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
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
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measures (fractional synthesis) of In vivo Triglyceride Synthesis
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 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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ursula White, Ph.D., Pennington Biomedical Research Center
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 (Actual)
June 20, 2018
Primary Completion (Actual)
February 28, 2020
Study Completion (Actual)
February 28, 2020
Study Registration Dates
First Submitted
May 2, 2018
First Submitted That Met QC Criteria
May 17, 2018
First Posted (Actual)
May 21, 2018
Study Record Updates
Last Update Posted (Actual)
May 26, 2020
Last Update Submitted That Met QC Criteria
May 22, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 2018-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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