- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06377943
The Interaction Between Resting Metabolic Rate, Physical Activity and Thyroid Hormone in Females
April 30, 2024 updated by: John R. Speakman, Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
This Study is focused on the interaction between resting metabolic rate (RMR), physical activity (PA), and thyroid hormones (TH).
TH controls almost all the cell activities of the body so, it is known as one of the major regulatory hormones.
This is the reason for individuals who suffer from thyroid disorders show abnormal metabolism.
Recently it was suggested that interindividual variations in thyroid hormone levels also influence daily physical activity.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
In this study, investigators will recruit adult females with a BMI ≥18.5.
After the screening process, eligible volunteers will undergo certain measurements including body composition, resting metabolism daily physical activity, thyroid hormone levels, and total energy expenditure.
The investigators will access the changes in resting metabolism and daily physical activities with the differences in thyroid hormone levels.
Study Type
Observational
Enrollment (Estimated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: John R Speakman, PhD
- Phone Number: +86 15810868669
- Email: j.speakman@abdn.ac.uk
Study Contact Backup
- Name: Sanduni S De Alwis, Bachelor
- Phone Number: +86 19065020853
- Email: alwis@siat.ac.cn
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
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The study participants are adult healthy females.
Description
Inclusion Criteria:
- Female age ≥18;
- BMI≥18.5
Exclusion Criteria:
- Intended weight change exceeding 2kg within the past three months;
- Having any special medical diets or having eating disorders;
- Pregnant women or breastfeeding women;
- People who have metal implants in their bodies;
- Patients with metabolic diseases, infectious diseases, and genetic disorders such as hypothyroidism, and hyperthyroidism;
- Patients with a personal or family history of medullary thyroid carcinoma (MTC), or patients with rare type 2 multiple endocrine tumor syndrome (MEN2); People with a fear of needles (Trypanophobia), claustrophobia; People who are fear of blood (Hemophobia) or pathological hypotension;
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body weight
Time Frame: Measurements will take at the first day of the visit
|
Subjects will be asked to fast overnight and weight will be measured using a calibrated Seca body weight scale first thing in the morning on subjects wearing light clothes and no shoes.
|
Measurements will take at the first day of the visit
|
Height
Time Frame: Measurements will take at the first day of the visit
|
Measured by seca 217 stable stadiometer.
Subjects wearing no shoes.
|
Measurements will take at the first day of the visit
|
Waist and Hip circumferences
Time Frame: Measurements will take at the first day of the visit
|
Waist and Hip circumferences will be measured using a whole body laser scanner.
|
Measurements will take at the first day of the visit
|
Fat mass
Time Frame: Measurements will take at the first day of the visit
|
Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ).
|
Measurements will take at the first day of the visit
|
Far free mass
Time Frame: Measurements will take at the first day of the visit
|
Fat free mass will be measured by Bioimpedance Analysis (Tanita, MC-980).
|
Measurements will take at the first day of the visit
|
Bone mass
Time Frame: Measurements will take at the first day of the visit
|
Bone mass will be measured by DEXA (Hologic).
|
Measurements will take at the first day of the visit
|
Resting Metabolism
Time Frame: Measurements will take at the first day of the visit.
|
Resting energy expenditure will be measured using indirect calorimetry via a respiratory hood system (Cosmed).
The subject attends the lab after an overnight fast.
The person lies down on a flatbed and the hood is placed over their head.
Metabolic rates (oxygen consumption and CO2 production) are monitored for 30 minutes.
Calorimeters will be assessed with a turbine test to ensure the accuracy of measurements.
Validation via an alcohol burn will be performed monthly.
|
Measurements will take at the first day of the visit.
|
Physical activity
Time Frame: Measurements last for 14 days
|
Physical activity of the participants will be recorded using GT3X accelerometer worn near the hip for a consecutive period of 7 days.
The monitor should not be worn while bathing or swimming.
The first day is discarded along with any day where the wear time is less than 12 hours.
For a valid measure, the goal is to get 2 weekday and 2 weekend days.
|
Measurements last for 14 days
|
Thyroid hormone
Time Frame: Blood samples will collect at the first day of the visit.
|
Nurses will collect the blood samples on day 1.
Levels of circulating thyroid hormones will be measured using radio immune assay.
|
Blood samples will collect at the first day of the visit.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total energy expenditure
Time Frame: Measurements take for 14 days
|
Total energy expenditure (TEE) will be measured using the DLW method.
Urine samples from all participants in the DLW subset will be stored at -20 oC and analyzed in the laboratory of Dr. John Speakman at the Shenzhen Institute of Advanced Technology, Chinese Academy of sciences.
Isotopes will be measured in a benchtop near-infrared isotope gas analyzer, and mean CO2 production will be calculated from isotope ratios using the recently derived equation (Speakman et al 2021: Cell reports medicine).
TEE will then be calculated using mean CO2 production using the Weir equation.
|
Measurements take for 14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: John R Speakman, PhD, Shenzhen Institute of Advanced Technology, CAS
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 (Estimated)
May 1, 2024
Primary Completion (Estimated)
July 31, 2024
Study Completion (Estimated)
October 31, 2024
Study Registration Dates
First Submitted
April 17, 2024
First Submitted That Met QC Criteria
April 17, 2024
First Posted (Actual)
April 22, 2024
Study Record Updates
Last Update Posted (Estimated)
May 2, 2024
Last Update Submitted That Met QC Criteria
April 30, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIAT-IRB-240415-H0718
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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