Effect of L-Thyroxine on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism

NCT01831869 | Unknown Phase 4 DMC

• 1 other identifier: 2012GSF11824
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Subclinical hypothyroidism (SCH) is a common condition affecting 3-10% of the general population, especially in women older than 50 years old. It is controversial whether SCH can lead to increased risks of cardiovascular (CV) disease and whether treatment with L-thyroxine reverses these risks. The present study was designed to evaluate the effect of L-thyroxine treatment in SCH on lipid profile, atherosclerosis, endothelial function, serum inflammatory factors and adipocytokines.

Conditions

Hypothyroidism; Thyroid Diseases; Endocrine System Diseases

Keywords

Subclinical hypothyroidism; L-thyroxine; Lipid; endothelial function; inflammatory factor; adipocytokine

Outcome Measures

Primary Outcomes (2)

• change in lipid profile

  measured at baseline; 6 month; 12 months and 24 months.

• change in thickness of blood vessel wall

  measured at baseline; 6 months; 12 months and 24 months.

Secondary Outcomes (3)

• change in endothelial function

  measured at baseline; 6 months; 12 months and 24 months.

• change of adipocytokines

  measured at baseline; 6 months; 12 months and 24 months.

• Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis

  measured at baseline; 6 months; 12 months and 24 months.

Study Arms (2)

L-thyroxine

ACTIVE COMPARATOR

Oral administration, starting dose 25 or 50 micrograms once daily.

Drug: L-thyroxine

blank

NO INTERVENTION

no intervention

Interventions

L-thyroxine DRUG

L-thyroxine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female aged of 18 to 60 years old;
• Diagnosis was subclinical hypothyroidism(elevated serum thyroid-stimulating hormone levels with normal serum free T4 levels measured at least two times with a three-month interval);
• untreated.

You may not qualify if:

• Pregnancy or lactation women;
• Presence of pituitary/hypothalamic disorders, diabetes mellitus or other endocrinal and metabolic disorders;
• Presence of psychological or physical disabilities,acute infection, cerebrovascular or cardiovascular disease, chronic respiratory disease and other illnesses known to alter lipid metabolism;
• Taking lipid-lowering agents and other drugs that known to influence thyroid function, blood pressure, heart function or bile acids;
• Obviously poor compliance.

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

MeSH Terms

Conditions

Hypothyroidism; Thyroid Diseases; Endocrine System Diseases

Interventions

Thyroxine

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Jiajun Zhao

  Shandong Provincial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2013
• First Posted: April 15, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: September 12, 2018

Record last verified: 2018-09

Locations

CN (1)