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

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 Overview

• Status: Completed
• Conditions: Obesity; Metabolic Syndrome; Euthyroid Condition
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Actual): 373

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We enrolled obese patients with euthyroid function.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
high TSH and high FT4; patients with high TSH and high FT4	Other: no intervention; This study collected data only without any intervention.
high TSH and low FT4; patients with high TSH and low FT4	Other: no intervention; This study collected data only without any intervention.
high TSH and high FT3; patients with high TSH and high FT3	Other: no intervention; This study collected data only without any intervention.
high TSH and low FT3; patients with high TSH and low FT3	Other: no intervention; This study collected data only without any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
FBG≥6.1mmol/L	patients with fasting blood glucose 6.1mmol/L or more.	2015-2020
BG120≥7.8mmol/L	patients with 2 hour blood glucose 7.8mmol/L or more.	2015-2020
FINS≥24.9 pmol/ml	patients with fasting insulin 24.9 pmol/ml or more.	2015-2020
FCP≥4.4nmol/L	patients with fasting C-peptide 4.4nmol/L or more.	2015-2020

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Obesity; Metabolic Syndrome
• Other Study ID Numbers: THs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data (IPD) are not available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No