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

NCT04599374 | Completed

• 1 other identifier: THs
• Study Type: observational
• Target: 373
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Euthyroid Condition; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• meet the criteria of metabolism in the 2017 Chinese guideline

  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.

  2015-2020

Secondary Outcomes (5)

• high uric acid

  2015-2020

• FBG≥6.1mmol/L

  2015-2020

• BG120≥7.8mmol/L

  2015-2020

• FINS≥24.9 pmol/ml

  2015-2020

• FCP≥4.4nmol/L

  2015-2020

Study Arms (4)

high TSH and high FT4

patients with high TSH and high FT4

Other: no intervention

high TSH and low FT4

patients with high TSH and low FT4

Other: no intervention

high TSH and high FT3

patients with high TSH and high FT3

Other: no intervention

high TSH and low FT3

patients with high TSH and low FT3

Other: no intervention

Interventions

no intervention OTHER

This study collected data only without any intervention.

high TSH and high FT3; high TSH and high FT4; high TSH and low FT3; high TSH and low FT4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We enrolled obese patients with euthyroid function.

You may qualify if:

• \) 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 22, 2020
• Study Start: March 1, 2015
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share