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Completed

NCT Number: NCT04599374

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

This study collected data only without any intervention.

Primary outcomes

  1. meet the criteria of metabolism in the 2017 Chinese guideline

    Time frame: 2015-2020

    • 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.

Secondary outcomes

  1. high uric acid

    Time frame: 2015-2020

    female patients with uric acid over 360 umol/L and male female patients with uric acid over 420 umol/L

  2. FBG≥6.1mmol/L

    Time frame: 2015-2020

    patients with fasting blood glucose 6.1mmol/L or more.

  3. BG120≥7.8mmol/L

    Time frame: 2015-2020

    patients with 2 hour blood glucose 7.8mmol/L or more.

  4. FINS≥24.9 pmol/ml

    Time frame: 2015-2020

    patients with fasting insulin 24.9 pmol/ml or more.

  5. FCP≥4.4nmol/L

    Time frame: 2015-2020

    patients with fasting C-peptide 4.4nmol/L or more.

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2020
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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