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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:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00498238
First received: July 6, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  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: Open Label
Official Title: The Effect of Levothyroxine on Arterial Stiffness and Lipid Profile in Patients

Resource links provided by NLM:

U.S. FDA Resources

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

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

No publications provided

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

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

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013