Effect of L-thyroxine on progression of Carotid Atherosclerosis in Subclinical Hypothyroidism
Completed
- Conditions
- Atherosclerosis, subclinical hypothyroidismCirculatory SystemAtherosclerosis
- Registration Number
- ISRCTN64455739
- Lead Sponsor
- Robarts Research Institute (Canada)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 254
Inclusion Criteria
Male or female patients:
1. With subclinical hypothyroidism, defined as a TSH of 3 to 10 mU/L, and a normal serum free thyroxine level (FT4 11 to 25 pmol/L), and
2. Measurable plaque in the carotid arteries
3. Aged greater than or equal to 45 years
Exclusion Criteria
1. Unwilling to give informed consent
2. History of atrial fibrillation
3. Unstable angina, or angina requiring nitroglycerine as often as once a month
4. Unlikely to adhere to the protocol
5. Unlikely to survive 18 months because of severe illness such as cancer
6. At risk of pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of progression of carotid plaque volume (mm^3) measured by 3-D ultrasound at baseline and 18 months.
- Secondary Outcome Measures
Name Time Method 1. Intima-media thickness (IMT), measured at baseline and 18 months<br>2. Weight, waist circumference, measured every 6 months<br>3. Insulin resistance by Homeostasis Model Assessment (HOMA), homocysteine, lipids, measured at baseline and 19 months