ObesityNCT04599374
the Association Between Thyroid Hormones and Metabolic Components in Patients With Obesity
An observational study of Obesity and Euthyroid Condition, run by Shanghai 10th People's Hospital.
Trial summary
This study collected clinical data of obese patients with euthyroid function, including age, gender, height, weight, BMI, waist circumference, blood pressure, fasting blood sugar, blood sugar 2 hours after sugar load, fasting plasma high-density lipoprotein cholesterol, fasting three acyl glycerin, free iodine thyroid… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Euthyroid Condition, Metabolic Syndrome
- How many people
- 373 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 30 Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We enrolled obese patients with euthyroid function.
Who may be able to join
- 1) age ranged from 18-65 years old, 2) BMI over 27.9kg/m2,3)TSH，FT4, and FT3 within the range of 0.38-4.34mIU/L, 10.5-24.4mIU/L, and 2.8-6.3mIU/L, respectively.
Who cannot join
- secondary cause of obesity such as hypothalamic obesity, Cushing syndrome, and hypophysis dysfunction, etc.,2)pregnancy or location, 3) severe heart, liver and kidney dysfunction
About this study
This study collected clinical data of obese patients with euthyroid function, including age, gender, height, weight, BMI, waist circumference, blood pressure, fasting blood sugar, blood sugar 2 hours after sugar load, fasting plasma high-density lipoprotein cholesterol, fasting three acyl glycerin, free iodine thyroid hormone (FT3) and free thyroid hormones (FT4), thyroid stimulating hormone (TSH), follow-up information and etc. Via analyzing the data, the investigators want to investigate the association between thyroid hormones (THs) and metabolic components in obese patients with euthyroid function and to present the cutoff values of THs in order to provide new information for the risk stratification of metabolic syndrome in obese patients with euthyroid function.
- Conditions
- Obesity, Euthyroid Condition, Metabolic Syndrome
- Being tested
- no intervention
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
This study collected data only without any intervention.
| Study group | Role | What they receive |
|---|---|---|
| high TSH and high FT4 | patients with high TSH and high FT4 Receives: Other: no intervention | |
| high TSH and low FT4 | patients with high TSH and low FT4 Receives: Other: no intervention | |
| high TSH and high FT3 | patients with high TSH and high FT3 Receives: Other: no intervention | |
| high TSH and low FT3 | patients with high TSH and low FT3 Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
meet the criteria of metabolism in the 2017 Chinese guideline
- Abdominal obesity (or central obesity), male abdominal circumference ≥90cm, female abdominal circumference ≥85 cm;
- Hypertension, those who have been diagnosed with hypertension and are in treatment and (or) blood pressure ≥130/85mmHg (1mmHg = 0.133kPa);
- Hyperglycemia, those who have been diagnosed with diabetes and are treated and (or) fasting blood glucose ≥6.1mmol/L or 2h blood glucose ≥7.8mmol/L after glucose load;
- Fasting high-density lipoprotein cholesterol (HDL-C) <1.04mmol/L;
- Fasting triacylglycerol ≥1.70mmol/L.
Measured: 2015-2020
Secondary outcomes (5)
high uric acid
female patients with uric acid over 360 umol/L and male female patients with uric acid over 420 umol/L
Measured: 2015-2020
FBG≥6.1mmol/L
patients with fasting blood glucose 6.1mmol/L or more.
Measured: 2015-2020
BG120≥7.8mmol/L
patients with 2 hour blood glucose 7.8mmol/L or more.
Measured: 2015-2020
FINS≥24.9 pmol/ml
patients with fasting insulin 24.9 pmol/ml or more.
Measured: 2015-2020
FCP≥4.4nmol/L
patients with fasting C-peptide 4.4nmol/L or more.
Measured: 2015-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Mar 2015
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
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.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Qu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599374
- Sponsor's protocol ID
- THs
- Status last verified
- Dec 2020
- First submitted
- 29 Sep 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) are not available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Association Between Thyroid Hormones and Metabolic Components in Patients With Obesity
- ClinicalTrials.gov ID
- NCT04599374
- Acronym / sponsor ID
- THs
- Conditions
- Obesity, Euthyroid Condition, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 22 Oct 2020 (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.
This study collected clinical data of obese patients with euthyroid function, including age, gender, height, weight, BMI, waist circumference, blood pressure, fasting blood sugar, blood sugar 2 hours after sugar load, fasting plasma high-density lipoprotein cholesterol, fasting three acyl glycerin, free iodine thyroid hormone (FT3) and free thyroid hormones (FT4), thyroid stimulating hormone (TSH), follow-up information and etc. Via analyzing the data, the investigators want to investigate the association between thyroid hormones (THs) and metabolic components in obese patients with euthyroid function and to present the cutoff values of THs in order to provide new information for the risk stratification of metabolic syndrome in obese patients with euthyroid function.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| high TSH and high FT4 | – | Other: no interventionpatients with high TSH and high FT4 |
| high TSH and low FT4 | – | Other: no interventionpatients with high TSH and low FT4 |
| high TSH and high FT3 | – | Other: no interventionpatients with high TSH and high FT3 |
| high TSH and low FT3 | – | Other: no interventionpatients with high TSH and low FT3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We enrolled obese patients with euthyroid function.
Key inclusion criteria (1 listed)
- 1) age ranged from 18-65 years old, 2) BMI over 27.9kg/m2,3)TSH，FT4, and FT3 within the range of 0.38-4.34mIU/L, 10.5-24.4mIU/L, and 2.8-6.3mIU/L, respectively.
Key exclusion criteria (1 listed)
- secondary cause of obesity such as hypothalamic obesity, Cushing syndrome, and hypophysis dysfunction, etc.,2)pregnancy or location, 3) severe heart, liver and kidney dysfunction
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 |
|---|---|---|
| no interventionThis study collected data only without any intervention. | Other | high TSH and high FT3, high TSH and high FT4, high TSH and low FT3, high TSH and low FT4 |
Primary outcome
meet the criteria of metabolism in the 2017 Chinese guideline
Time frame: 2015-2020
1. Abdominal obesity (or central obesity), male abdominal circumference ≥90cm, female abdominal circumference ≥85 cm; 2. Hypertension, those who have been diagnosed with hypertension and are in treatment and (or) blood pressure ≥130/85mmHg (1mmHg = 0.133kPa); 3. Hyperglycemia, those who have been diagnosed with diabetes and are treated and (or) fasting blood glucose ≥6.1mmol/L or 2h blood glucose ≥7.8mmol/L after glucose load; 4. Fasting high-density lipoprotein cholesterol (HDL-C) <1.04mmol/L; 5. Fasting triacylglycerol ≥1.70mmol/L.
5 secondary outcomes
high uric acid
Time frame: 2015-2020
FBG≥6.1mmol/L
Time frame: 2015-2020
BG120≥7.8mmol/L
Time frame: 2015-2020
FINS≥24.9 pmol/ml
Time frame: 2015-2020
FCP≥4.4nmol/L
Time frame: 2015-2020
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 24 Dec 2020.
- Individual participant dataSharing planned: No. The individual participant data (IPD) are not available to other researchers.
Related trials for Obesity
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Recruiting
Confident Moves Intervention Efficacy Trial: Obesity Care Settings
Obesity, Overweight
Not yet recruiting
Stearic Acid and Endothelial Function
Healthy Middle-aged Subjects, Obesity & Overweight
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Euthyroid Condition, run by Shanghai 10th People's Hospital.
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 1 inclusion and 1 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 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
meet the criteria of metabolism in the 2017 Chinese guideline (time frame: 2015-2020). 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 24 Dec 2020.