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

This study has been completed.

First Received: July 6, 2007 No Changes Posted

Sponsor:	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

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

Resource links provided by NLM:

Drug Information available for: Thyroxine Levothyroxine Sodium Levothroid Lipids

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

Study ID Numbers:	ronit1
Study First Received:	July 6, 2007
Last Updated:	July 6, 2007
ClinicalTrials.gov Identifier:	NCT00498238 History of Changes
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:

Endocrine System Diseases
Hypothyroidism
Thyroid Diseases

ClinicalTrials.gov processed this record on February 08, 2010