The Interaction Between Resting Metabolic Rate, Physical Activity and Thyroid Hormone in Females

Thyroid Clinical Trial

Official title:

The Interaction Between Resting Metabolic Rate, Physical Activity and Thyroid Hormone in Females

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06377943
• Other study ID #: SIAT-IRB-240415-H0718
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
• Contact: John R Speakman, PhD
• Phone: 15810868669
• Email: j.speakman[@]abdn.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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;

Related Conditions & MeSH terms

• Physical Activities
• Resting Energy Expenditure
• Thyroid
• Thyroid Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	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
Primary	Height	Measured by seca 217 stable stadiometer. Subjects wearing no shoes.	Measurements will take at the first day of the visit
Primary	Waist and Hip circumferences	Waist and Hip circumferences will be measured using a whole body laser scanner.	Measurements will take at the first day of the visit
Primary	Fat mass	Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ).	Measurements will take at the first day of the visit
Primary	Far free mass	Fat free mass will be measured by Bioimpedance Analysis (Tanita, MC-980).	Measurements will take at the first day of the visit
Primary	Bone mass	Bone mass will be measured by DEXA (Hologic).	Measurements will take at the first day of the visit
Primary	Resting Metabolism	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.
Primary	Physical activity	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
Primary	Thyroid hormone	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	Total energy expenditure	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