Fatigue In Subclinical Hypothyroidism
| ISRCTN | ISRCTN70749570 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70749570 |
| Protocol serial number | N/A |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) |
| Funder | BUPA Foundation (UK) (ref: 22094167) |
- Submission date
- 06/01/2010
- Registration date
- 15/05/2013
- Last edited
- 22/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Having a mild underactive thyroid (thyroid gland not producing enough hormone) is a common medical condition affecting 5-10% of the general population. Fatigue and problems relating to ones thought process (cognitive symptoms) are frequently reported in patients with this condition. It is unclear whether these symptoms are caused by the underactive thyroid. The study aims to find out the mechanisms of fatigue and cognitive symptoms in patients with this condition.
Who can participate?
We aim to recruit 20 patients with mild thyroid underactive state (men or women, aged between 18 and 65 years) and 20 healthy volunteers who will act as control.
What does the study involve?
Patients and healthy volunteers will undergo preliminary clinical assessment. If they are eligible, then they will have a series of tests. These involve magnetic resonance imaging scans (MRI scans) of the brain, heart and leg muscle; assessing heart rate and blood pressure over a period of 2 hours; and psychometric tests for intelligence, reading and memory. The patients will have these tests again after being given thyroxine treatment for 6 months.
What are the possible benefits and risks of participating?
Participants may or may not benefit personally by taking part in this study. But the results may eventually change how we manage fatigue in the future and therefore have benefits for others.
The study involves a series of assessments, which means we will be asking for a significant amount of time. Furthermore, there is a very small possibility that during the tests we may discover an incidental abnormality that we have not expected. If this is the case we will liaise with the participants doctor in order to ensure that any appropriate action is taken. Patients may experience mild side-effects from thyroxine treatment if they take too much, but this is monitored closely.
Where is the study run from?
The study has been set up by Gateshead Health NHS Trust, Gateshead, UK.
When is the study starting and how long is it expected to run for?
January 2010 to January 2012
Who is funding the study?
BUPA Foundation (UK)
Who is the main contact?
Prof Julia Newton
Julia.Newton@ncl.ac.uk
Contact information
Scientific
FASS unit
Leazes Wing
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre open label trial |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Investigating the mechanisms of muscle fatigue and cognitive symptoms in subclinical hypothyroidism |
| Study acronym | FISH |
| Study objectives | Individuals with subclinical hypothyroidism (SCH) have fatigue due to a combination of cerebral, cardiac and skeletal muscle abnormalities as well as autonomic dysfunction and that this fatigue is (partly or fully) reversible with treatment. |
| Ethics approval(s) | Newcastle & North Tyneside 2 Research Ethics Committee approved on the 20/08/2009, ref: NO-08/H0907/53 |
| Health condition(s) or problem(s) studied | Subclinical hypothyroidism |
| Intervention | All patients are treated with tablet thyroxine for 6 months, at a dose of 1.6 µg/Kg, titrated 6 - 8 weekly, to attain a TSH of 1 - 1.5 mU/L. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Thyroxine |
| Primary outcome measure(s) |
1. Brain magnetic resonance imaging (MRI) - regional cerebral blood flow and activation of specific regions of intererest during N-back testing at baseline and 6 months |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 10/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Aged 18 to 65 years 2. Subjects with confirmed SCH thyroid stimulating hormone (TSH) between 4.1 and 10.0 for more than 3 months 3. Fatigue Impact Score greater than 40 |
| Key exclusion criteria | 1. Subjects with previous thyroid disease or on thyroid hormone replacement, anti-thyroid drugs, oral contraceptive pill (OCP), hypotensive agents, aspirin, statins or angiotensin converting enzyme (ACE) inhibitors/angiotensin receptor blocker 2. Subjects with known diabetes mellitus/impaired glucose tolerance (IGT)/impaired fasting glucose (IFG) 3. Known renal failure or a serum creatinine greater than 120 µmol/l within the past 3 months 4. Previous participation in a clinical trial within the past month 5. Previous history of vascular/heart disease 6. Malignancy (any) 7. Active infections 8. Body mass index (BMI) greater than 35 9. Psychiatric disease 10. Drug abuse 11. Previous major head injuries/epilepsy 12. Pacemakers/cerebral aneurysm clips 13. Pregnancy |
| Date of first enrolment | 07/01/2010 |
| Date of final enrolment | 10/01/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
NE1 4LP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
22/02/2019: Thesis added to publication and dissemination plan.
14/06/2016: No publications found, verifying study status with principal investigator.
