the Association Between Thyroid Hormones and Metabolic Components in Patients With Obesity

Completed

• Conditions: Metabolic Syndrome; Euthyroid Condition; Obesity
• Interventions: Other: no intervention

• Registration Number: NCT04599374
• Lead Sponsor: Shanghai 10th People's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-01
• Study First Submitted: 2020-09-29
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-22
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2020-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
high TSH and high FT4	no intervention	patients with high TSH and high FT4
high TSH and low FT4	no intervention	patients with high TSH and low FT4
high TSH and low FT3	no intervention	patients with high TSH and low FT3
high TSH and high FT3	no intervention	patients with high TSH and high FT3

Primary Outcome Measures

Name	Time	Method
meet the criteria of metabolism in the 2017 Chinese guideline	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.

Secondary Outcome Measures

Name	Time	Method
FBG≥6.1mmol/L	2015-2020	patients with fasting blood glucose 6.1mmol/L or more.
FINS≥24.9 pmol/ml	2015-2020	patients with fasting insulin 24.9 pmol/ml or more.
FCP≥4.4nmol/L	2015-2020	patients with fasting C-peptide 4.4nmol/L or more.
high uric acid	2015-2020	female patients with uric acid over 360 umol/L and male female patients with uric acid over 420 umol/L
BG120≥7.8mmol/L	2015-2020	patients with 2 hour blood glucose 7.8mmol/L or more.