search
Back to results

Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

Primary Purpose

Subclinical Hypothyroidism

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Levothyroxine
Placebo
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subclinical Hypothyroidism focused on measuring Subclinical hypothyroidism, Atherosclerosis, Cardiovascular disease, Endothelial function, Prevention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18 to 65
  • confirmed subclinical hypothyroidism

Exclusion Criteria:

  • receiving of other treatments for hypothyroidism
  • patients with other major medical disorders
  • smoking
  • hyperlipidemia
  • obesity

Sites / Locations

  • Khorshid endocrinology clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Levothyroxin

Placebo

Arm Description

In the treatment group, daily doses of 100 mg of Levothyroxine will be administered every morning, half an hour before breakfast.

In the placebo group treatment regimen and advices are identical to that of the treatment group, except for using a pharmacologically neutral agent, with complete resemblance to the real treatment.

Outcomes

Primary Outcome Measures

Change from baseline flow-mediated dilation at 2 months
Flow-mediated dilation will be assessed using standard method with a radiologist unaware to the study arms at baseline and then 2 months after treatment.
Change from baseline intima-media thickness at 2 months
Intima-media thickness will be assessed using standard method with a radiologist unaware to the study arms at baseline and then 2 months after treatment.

Secondary Outcome Measures

Full Information

First Posted
March 12, 2014
Last Updated
March 17, 2014
Sponsor
Isfahan University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT02090907
Brief Title
Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism
Official Title
Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypothyroidism is risk factor in atherosclerotic cardiovascular diseases, but there is a controversy in effect of subclinical hypothyroidism on cardiovascular diseases. We aim to estimate the relation between subclinical hypothyroidism and endothelial dysfunction and the effects of levothyroxine therapy on it. Patients with confirmed subclinical hypothyroidism by lab results will be randomized to two groups of treatment with one daily dose of 100 mg Levothyroxine or placebo. The flow-mediated dilation and intima media thickness are evaluated before and after the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subclinical Hypothyroidism
Keywords
Subclinical hypothyroidism, Atherosclerosis, Cardiovascular disease, Endothelial function, Prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levothyroxin
Arm Type
Experimental
Arm Description
In the treatment group, daily doses of 100 mg of Levothyroxine will be administered every morning, half an hour before breakfast.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
In the placebo group treatment regimen and advices are identical to that of the treatment group, except for using a pharmacologically neutral agent, with complete resemblance to the real treatment.
Intervention Type
Drug
Intervention Name(s)
Levothyroxine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from baseline flow-mediated dilation at 2 months
Description
Flow-mediated dilation will be assessed using standard method with a radiologist unaware to the study arms at baseline and then 2 months after treatment.
Time Frame
At baseline and then 2 months after treatment
Title
Change from baseline intima-media thickness at 2 months
Description
Intima-media thickness will be assessed using standard method with a radiologist unaware to the study arms at baseline and then 2 months after treatment.
Time Frame
At baseline and then 2 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 to 65 confirmed subclinical hypothyroidism Exclusion Criteria: receiving of other treatments for hypothyroidism patients with other major medical disorders smoking hyperlipidemia obesity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasmi Niknam, M.D.
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Khorshid endocrinology clinic
City
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
16314542
Citation
Walsh JP, Bremner AP, Bulsara MK, O'Leary P, Leedman PJ, Feddema P, Michelangeli V. Subclinical thyroid dysfunction as a risk factor for cardiovascular disease. Arch Intern Med. 2005 Nov 28;165(21):2467-72. doi: 10.1001/archinte.165.21.2467.
Results Reference
background
PubMed Identifier
21505892
Citation
Alibaz Oner F, Yurdakul S, Oner E, Kubat Uzum A, Erguney M. Evaluation of the effect of L-thyroxin therapy on endothelial functions in patients with subclinical hypothyroidism. Endocrine. 2011 Oct;40(2):280-4. doi: 10.1007/s12020-011-9465-2. Epub 2011 Apr 20.
Results Reference
background

Learn more about this trial

Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

We'll reach out to this number within 24 hrs