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The Effect of Levothyroxine on Arterial Stiffness and Lipid Profile in Patients With Subclinical Hypothyroidism

This study has been completed.

Sponsored by: Assaf-Harofeh Medical Center
Information provided by: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00498238
  Purpose

We evaluated the effect of levothyroxine in subclinical hypothyroidism (SCH) on arterial stiffness, lipid profile and inflammation. Thirty-four patients with SCH were included. Patients were treated with levothyroxine for 7 months. Arterial stiffness was evaluated by Augmentation index (AIx). After accomplishing euthyroidism, the AIx decreased from 8.3±17.2 to 6.5±14.3(P<0.01) and AIx percentage decreased from36.2 11.5 ± to 9.1±33.2 (P =0.03). Systolic blood pressure decreased from 20±134.7 to mmHg 13.7±127.6 (P<0.01). No significant improvement was found in other parameters. In patients whose AIx's decreased, LDL-cholesterol levels decreased by 37.1±-15.5 mg/dl compared to the patients whose AIx's didn't decrease and LDL-cholesterol increased by 57.4±24.1 mg/dl (P=0.057). We concluded that in patients suffering from SCH, treatment with levothyroxine had a significant beneficial effect on arterial stiffness and systolic blood pressure and no effect on lipid profile or inflammation.


Condition Intervention
Subclinical Hypothyroidism
Drug: Levothyroxine

ChemIDplus related topics:   Levothyroxine Sodium    Thyroxine    Lipids   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Open Label, Uncontrolled, Single Group Assignment
Official Title:   The Effect of Levothyroxine on Arterial Stiffness and Lipid Profile in Patients

Further study details as provided by Assaf-Harofeh Medical Center:

Enrollment:   34
Study Start Date:   July 2003
Study Completion Date:   September 2005

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Laboratory evidence of subclinical hypothyroidism (TSH levels 4-25 mU/L and normal T4 values) in at least two following tests (one month apart from each other)

Exclusion Criteria:

  • Recent (less than 6 months) myocardial infarction, cerebrovascular event or angiography with stent placement
  • Serious infection in the month before recruitment
  • Any use of contrast media in the last 6 months
  • Loss of more than 5% of body weight during the last 6 months
  • Cardiac arrhythmias
  • Ejection fraction of less than 40%
  • Active malignant diseases
  • Previous thyroid disease and
  • Pregnancy.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498238

Sponsors and Collaborators
Assaf-Harofeh Medical Center

Investigators
Principal Investigator:     Ronit Koren, MD     Department of Internal Medicine A , Research & Development unit Assaf Harofeh Medical Center, Zerifin, affiliated to Sackler School of Medicine,    
  More Information


Study ID Numbers:   ronit1
First Received:   July 6, 2007
Last Updated:   July 6, 2007
ClinicalTrials.gov Identifier:   NCT00498238
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Assaf-Harofeh Medical Center:
Arterial stiffness, Augmentation index, Subclinical Hypothyroidism  

Study placed in the following topic categories:
Endocrine System Diseases
Hypothyroidism
Endocrinopathy
Thyroid Diseases

ClinicalTrials.gov processed this record on October 06, 2008




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