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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04599374
Other study ID # THs
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2015
Est. completion date September 30, 2020

Study information

Verified date December 2020
Source Shanghai 10th People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 373
Est. completion date September 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
This study collected data only without any intervention.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai 10th People's Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
2015-2020
Secondary high uric acid female patients with uric acid over 360 umol/L and male female patients with uric acid over 420 umol/L 2015-2020
Secondary FBG=6.1mmol/L patients with fasting blood glucose 6.1mmol/L or more. 2015-2020
Secondary BG120=7.8mmol/L patients with 2 hour blood glucose 7.8mmol/L or more. 2015-2020
Secondary FINS=24.9 pmol/ml patients with fasting insulin 24.9 pmol/ml or more. 2015-2020
Secondary FCP=4.4nmol/L patients with fasting C-peptide 4.4nmol/L or more. 2015-2020
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