|
Welcome
|
|
11 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Subclinical hypothyroidism (SCH), cardiovascular risk and quality of life |
| ISRCTN | ISRCTN35570362 |
| ClinicalTrials.gov identifier | |
| Public title | Subclinical hypothyroidism (SCH), cardiovascular risk and quality of life |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | 199/MED |
| Study hypothesis | The cardiovascular risk in people with SCH, health status and quality of life can be improved by treatment with L-thyroxine. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Double blind randomised controlled crossover study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Subclinical hypothyroidism |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/02/2003 |
| Anticipated end date | 10/01/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 100 |
| Interventions | Double blind randomised controlled crossover study using thyroxine (100 mcg/day) versus placebo. |
| Primary outcome measure(s) | 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 measure(s) |
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 |
| Sources of funding |
1. NHS Research and Development (UK)
2. Research Endocrine Fund (UK) 3. Gateshead Diabetes Charitable Fund (UK) |
| Trial website | |
| Publications |
For information:
Health status in patients with sub-clinical hypothyroidism. Razvi S, Ingoe LE, McMillan CV, Weaver JU Eur J Endocrinol. 2005;152:713-7. See http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15879356 For results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=17299073 |
| Contact name | Dr Jolanta Weaver |
| Address |
Queen Elizabeth Hospital
Sheriff Hill |
| City/town | Gateshead |
| Zip/Postcode | NE9 6SX |
| Country | United Kingdom |
| Sponsor | Gateshead Health NHS Foundation Trust (UK) |
| Address |
Queen Elizabeth Hospital
Sheriff Hill Tyne and Wear |
| City/town | Gateshead |
| Zip/Postcode | NE9 6SX |
| Country | United Kingdom |
| Sponsor website: | http://www.gatesheadhealth.nhs.uk/ |
| Date applied | 19/09/2005 |
| Last edited | 09/05/2007 |
| Date ISRCTN assigned | 19/10/2005 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|