Obesity Clinical Trial
Official title:
the Association Between Thyroid Hormones and Metabolic Components in Patients With Obesity
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 |
Verified date | December 2020 |
Source | Shanghai 10th People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shanghai 10th People's Hospital |
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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