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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00498238
First Posted: July 9, 2007
Last Update Posted: July 9, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Effect of Levothyroxine on Arterial Stiffness and Lipid Profile in Patients

Resource links provided by NLM:


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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00498238     History of Changes
Other Study ID Numbers: ronit1
First Submitted: July 6, 2007
First Posted: July 9, 2007
Last Update Posted: July 9, 2007
Last Verified: July 2007

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

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases