Subclinical hypothyroidism (SCH), cardiovascular risk and quality of life
Not Applicable
Completed
- Conditions
- Subclinical hypothyroidismNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN35570362
- Lead Sponsor
- Gateshead Health NHS Foundation Trust (UK)
- Brief Summary
2005 Other publications in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15879356 See 2007 Results article in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=17299073
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1. Subjects from Primary Care (general practices)
2. Aged 18 to 80 years of age
3. Who have at least two abnormal thyroid function tests
Exclusion Criteria
1. Thyroid disease and its treatment
2. Medications that could cause thyroid hormone dysfunction
3. Diabetes mellitus
4. Renal failure (serum creatinine greater than 120 µmol/l)
5. Vascular disease
6. Psychiatric conditions or its treatment
7. Current or previous pregnancy in the last two years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in brachial artery Flow Mediated Dilatation (FMD) as a marker of vascular endothelial function and Total Cholesterol (TC) levels, after 12 weeks of L-thyroxine treatment.
- Secondary Outcome Measures
Name Time Method <br> Changes in:<br> 1. Health status<br> 2. Quality of life<br> 3. Weight as assessed by body mass index<br> 4. Waist circumference and waist hip ratio<br> 5. Blood pressure<br> 6. Triglyceride<br> 7. High Density Lipoprotein (HDL) cholesterol<br> 8. Low Density Lipoprotein (LDL) cholesterol<br> 9. Apolipoprotein A1 and apolipoprotein B<br> 10. Serum markers of endothelial function (e-selectin, soluble adhesion molecule 1, tissue plasminogen activator and plasminogen activator inhibitor 1) and markers of inflammation high sensitive C-reactive protein<br>