Subclinical hypothyroidism Nutritional, Metabolic, Endocrine Subclinical hypothyroidism
Conditions
Interventions
Double blind randomised controlled crossover study using thyroxine (100 mcg/day) versus placebo.
Sponsors
Gateshead Health NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Changes in: 1. Health status 2. Quality of life 3. Weight as assessed by body mass index 4. Waist circumference and waist hip ratio 5. Blood pressure 6. Triglyceride 7. High Density Lipoprotein (HDL) cholesterol 8. Low Density Lipoprotein (LDL) cholesterol 9. Apolipoprotein A1 and apolipoprotein B 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 | — |
Countries
England, United Kingdom
Outcome results
None listed