DyslipidemiaPhase 3NCT01486667
Thyroxin Treatment in Sub Clinical Hypothyroidism, on the Apnea Hypopnea Index Score, Lipids and Highly Sensitive CRP
A Phase 3 study testing levothyroxine and sugar pill in people with Dyslipidemia, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Obstructive sleep apnea (OSA) and hypothyroidism are both commonly found in clinical practice, and share a number of symptoms and clinical features. It has been shown that hypothyroid subjects are at high risk of developing sleep disorder breathing and OSA, and adequate thyroxine treatment may reduce the sleep… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- levothyroxine and sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Oct 2011to Oct 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients >18 years old
- With Subclinical hypothyroidism defined as serum TSH concentration above 5.0 IU/mL when serum FT4 level is within the reference range
- With OSA defined as mild OSA: AHI 5 to 15/h; moderate OSA:AHI 15 to 30/h; and severe OSA: AHI greater than 30/h (30) will be enrolled.
- With confirmed sustained subclinical hypothyroidism, thus excluding patients with a temporary condition such as that in recovery from a non-thyroidal illness, measurement of TSH and FT4 will be conducted within four weeks before randomization.
Who cannot join
- Current treatment with Levothyroxine and lipid lowering medications or within two months before randomization.
- Conditions known to cause dyslipidemia e.g. uncontrolled diabetes mellitus (HbA1c >9), alcoholism and some medication use e.g. Estrogens. Glucocorticoids, Retinoids or Interferons.
- Conditions indicating levothyroxine treatment (34); including TSH levels more than 10 mU/l, clear symptoms or signs associated with thyroid failure and not related to OSA . e.g. goiter.
- State of pregnancy, Breast feeding or allergy to levothyroxine.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
University Sleep Disorders Center
Riyadh, Riyadh Region, 11472
Anwar A Jammah, MD, FACP,FRCPC, (+966 1) 467-11784; 467-9179, drjammah@gmail.com
Reda AboAlsoud, MD, +966509662742, usdc@ksu.edu.sa
About this study
Official title: Effect of Thyroxin Treatment in Sub Clinical Hypothyroidism Patients, on the Apnea Hypopnea Index Score, Lipid Profiles and Highly Sensitive CRP : A Randomized Double Blind Controlled Trial
Obstructive sleep apnea (OSA) and hypothyroidism are both commonly found in clinical practice, and share a number of symptoms and clinical features. It has been shown that hypothyroid subjects are at high risk of developing sleep disorder breathing and OSA, and adequate thyroxine treatment may reduce the sleep disordered breathing.. However, the time-course and effect of treating subclinical hypothyroidism in OSA patients on the respiratory events during sleep is not known.
Subclinical hypothyroidism is associated with an increased risk of coronary heart disease (CHD). Dyslipidemia is a known complications of subclinical hypothyroidism and the effect of thyroxine treatment on lipid profile is controversial . Some reports suggested higher serum high-sensitivity C-reactive protein (hs-CRP), than healthy subjects; however, the effect of levothyroxine is controversial.
This project will help us to know if the treatment of subclinical hypothyroidism will improve the symptoms and reduce the progression of OSA, which may improve patients' quality of life by reducing the complication of OSA (hypertension, , depression, Cardiovascular diseases, etc.) or may even reduce mortality.It will help us to know the effect of subclinical hypothyroidism treatment on of lipid profiles and hs-CRP.
Read the detailed description
Research Problem:
Obstructive sleep apnea (OSA) and hypothyroidism are both commonly found in clinical practice, and share a number of symptoms and clinical features. It has been shown that hypothyroid subjects are at high risk of developing sleep disorder breathing and OSA, and adequate thyroxine treatment may reduce the sleep disordered breathing.. However, the time-course and effect of treating subclinical hypothyroidism in OSA patients on the respiratory events during sleep is not known.
Subclinical hypothyroidism is associated with an increased risk of coronary heart disease (CHD). Dyslipidemia is a known complications of subclinical hypothyroidism (2)and the effect of thyroxine treatment on lipid profile is controversial . Some reports suggested higher serum high-sensitivity C-reactive protein (hs-CRP), than healthy subjects ; however, the effect of levothyroxine is controversial .
Research Significance:
This project will help us to know if the treatment of subclinical hypothyroidism will improve the symptoms and reduce the progression of OSA, which may improve patients' quality of life by reducing the complication of OSA (hypertension, , depression, Cardiovascular diseases, etc.) or may even reduce mortality.
It will help us to know the effect of subclinical hypothyroidism treatment on of lipid profiles and hs-CRP.
Research Objectives:
Primary objective:
- Effect of the treatment of subclinical hypothyroidism on the apnea hypopnea index (AHI) score.
Secondary objectives:
- Effect of the treatment of subclinical hypothyroidism on the lipid profile in patient with dyslipidemia.
- Effect of the treatment of subclinical hypothyroidism on hs-CRP
Research Methodology:
Patients with subclinical hypothyroidism will undergo first Polysomnography (PSG) (night 0) and laboratory investigations including lipid profiles and hc-CRP and then they will be enrolled and randomly assigned to receive either levothyroxine replacement therapy or identical placebo tablets in a blinded manner. The starting dose will be 25 mcg/day and the dose will be adjusted every 6 weeks to target TSH level between (0.25 -2.5 IU/mL). We will keep all patients on replacement dose for duration of 24 weeks. PSG will be performed twice only for OSA patient, after 12 weeks (night 1) and after 24 weeks (night 2). Lipid profile and hs-CRP will be done at the end of 24th weeks.
- Conditions
- Dyslipidemia
- Being tested
- levothyroxine, sugar pill
- Keywords
- focus of study instead
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levothyroxineDrug
Eligible patients will be randomized and be given 25 mcg of levothyroxine or identical placebo tablet at the beginning of the enrollment. The dosage of levothyroxine will subsequently be individualized for each patients according to Serum levels of TSH and FT4 which will be checked initially and then every 6 weeks until the end of the study. The investigators will attempt to maintain TSH levels between (0.25-2.5) mU/l which is the lower half of normal range by adding or reducing the dose of levothyroxine. Advice given to patient regarding whether to increase or decrease the dose of medications will be based on patient TSH level according to study protocol.
sugar pillDrug
Eligible patients will be randomized and be given 25 mcg of levothyroxine or identical placebo tablet at the beginning of the enrollment. The dosage of drug will subsequently be individualized for each patients according to Serum levels of TSH and FT4 which will be checked initially and then every 6 weeks until the end of the study. The investigators will attempt to maintain TSH levels between (0.25-2.5) mU/l which is the lower half of normal range by adding or reducing the dose of medication. Advice given to patient regarding whether to increase or decrease the dose of medications will be based on patient TSH level according to study protocol.
| Study group | Role | What they receive |
|---|---|---|
| sugar pill | Placebo comparator | Not described Receives: Drug: sugar pill |
| Levothyroxine | Active comparator | Eligible patients will be randomized and be given 25 mcg of levothyroxine or identical placebo tablet at the beginning of the enrollment. The dosage of levothyroxine will subsequently be individualized for each patients. Serum levels of TSH and FT4 will be checked initially and then every 6 weeks until the end of the study. The investigators will attempt to maintain TSH levels between (0.25-2.5) mU/l which is the lower half of normal range. Advice given to patient regarding whether to increase or decrease the dose of medications will be based on patient TSH level according to study protocol. Receives: Drug: levothyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the treatment of subclinical hypothyroidism on the apnea hypopnea index (AHI) score.
Measured: 24 weeks
Secondary outcomes (1)
Effect of the treatment of subclinical hypothyroidism on the lipid profile in patient with dyslipidemia and on hs-CRP
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anwar Ali Jammah, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486667
- Sponsor's protocol ID
- E-11-465
- Status last verified
- Dec 2011
- First submitted
- 3 Dec 2011
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thyroxin Treatment in Sub Clinical Hypothyroidism Patients, on the Apnea Hypopnea Index Score, Lipid Profiles and Highly Sensitive CRP : A Randomized Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT01486667
- Acronym / sponsor ID
- E-11-465
- Conditions
- Dyslipidemia
- Keywords
- focus of study instead
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (estimated)
- First posted
- 6 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnea (OSA) and hypothyroidism are both commonly found in clinical practice, and share a number of symptoms and clinical features. It has been shown that hypothyroid subjects are at high risk of developing sleep disorder breathing and OSA, and adequate thyroxine treatment may reduce the sleep disordered breathing.. However, the time-course and effect of treating subclinical hypothyroidism in OSA patients on the respiratory events during sleep is not known.
Subclinical hypothyroidism is associated with an increased risk of coronary heart disease (CHD). Dyslipidemia is a known complications of subclinical hypothyroidism and the effect of thyroxine treatment on lipid profile is controversial . Some reports suggested higher serum high-sensitivity C-reactive protein (hs-CRP), than healthy subjects; however, the effect of levothyroxine is controversial.
This project will help us to know if the treatment of subclinical hypothyroidism will improve the symptoms and reduce the progression of OSA, which may improve patients' quality of life by reducing the complication of OSA (hypertension, , depression, Cardiovascular diseases, etc.) or may even reduce mortality.It will help us to know the effect of subclinical hypothyroidism treatment on of lipid profiles and hs-CRP.
Detailed description
Research Problem:
Obstructive sleep apnea (OSA) and hypothyroidism are both commonly found in clinical practice, and share a number of symptoms and clinical features. It has been shown that hypothyroid subjects are at high risk of developing sleep disorder breathing and OSA, and adequate thyroxine treatment may reduce the sleep disordered breathing.. However, the time-course and effect of treating subclinical hypothyroidism in OSA patients on the respiratory events during sleep is not known.
Subclinical hypothyroidism is associated with an increased risk of coronary heart disease (CHD). Dyslipidemia is a known complications of subclinical hypothyroidism (2)and the effect of thyroxine treatment on lipid profile is controversial . Some reports suggested higher serum high-sensitivity C-reactive protein (hs-CRP), than healthy subjects ; however, the effect of levothyroxine is controversial .
Research Significance:
This project will help us to know if the treatment of subclinical hypothyroidism will improve the symptoms and reduce the progression of OSA, which may improve patients' quality of life by reducing the complication of OSA (hypertension, , depression, Cardiovascular diseases, etc.) or may even reduce mortality.
It will help us to know the effect of subclinical hypothyroidism treatment on of lipid profiles and hs-CRP.
Research Objectives:
Primary objective:
- Effect of the treatment of subclinical hypothyroidism on the apnea hypopnea index (AHI) score.
Secondary objectives:
- Effect of the treatment of subclinical hypothyroidism on the lipid profile in patient with dyslipidemia.
- Effect of the treatment of subclinical hypothyroidism on hs-CRP
Research Methodology:
Patients with subclinical hypothyroidism will undergo first Polysomnography (PSG) (night 0) and laboratory investigations including lipid profiles and hc-CRP and then they will be enrolled and randomly assigned to receive either levothyroxine replacement therapy or identical placebo tablets in a blinded manner. The starting dose will be 25 mcg/day and the dose will be adjusted every 6 weeks to target TSH level between (0.25 -2.5 IU/mL). We will keep all patients on replacement dose for duration of 24 weeks. PSG will be performed twice only for OSA patient, after 12 weeks (night 1) and after 24 weeks (night 2). Lipid profile and hs-CRP will be done at the end of 24th weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugar pill | Placebo comparator | Drug: sugar pill |
| Levothyroxine | Active comparator | Drug: levothyroxineEligible patients will be randomized and be given 25 mcg of levothyroxine or identical placebo tablet at the beginning of the enrollment. The dosage of levothyroxine will subsequently be individualized for each patients. Serum levels of TSH and FT4 will be checked initially and then every 6 weeks until the end of the study. The investigators will attempt to maintain TSH levels between (0.25-2.5) mU/l which is the lower half of normal range. Advice given to patient regarding whether to increase or decrease the dose of medications will be based on patient TSH level according to study protocol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients >18 years old
- With Subclinical hypothyroidism defined as serum TSH concentration above 5.0 IU/mL when serum FT4 level is within the reference range
- With OSA defined as mild OSA: AHI 5 to 15/h; moderate OSA:AHI 15 to 30/h; and severe OSA: AHI greater than 30/h (30) will be enrolled.
- With confirmed sustained subclinical hypothyroidism, thus excluding patients with a temporary condition such as that in recovery from a non-thyroidal illness, measurement of TSH and FT4 will be conducted within four weeks before randomization.
Key exclusion criteria (4 listed)
- Current treatment with Levothyroxine and lipid lowering medications or within two months before randomization.
- Conditions known to cause dyslipidemia e.g. uncontrolled diabetes mellitus (HbA1c >9), alcoholism and some medication use e.g. Estrogens. Glucocorticoids, Retinoids or Interferons.
- Conditions indicating levothyroxine treatment (34); including TSH levels more than 10 mU/l, clear symptoms or signs associated with thyroid failure and not related to OSA . e.g. goiter.
- State of pregnancy, Breast feeding or allergy to levothyroxine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levothyroxineEligible patients will be randomized and be given 25 mcg of levothyroxine or identical placebo tablet at the beginning of the enrollment. The dosage of levothyroxine will subsequently be individualized for each patients according to Serum levels of TSH and FT4 which will be checked initially and then every 6 weeks until the end of the study. The investigators will attempt to maintain TSH levels between (0.25-2.5) mU/l which is the lower half of normal range by adding or reducing the dose of levothyroxine. Advice given to patient regarding whether to increase or decrease the dose of medications will be based on patient TSH level according to study protocol. | Drug | Levothyroxine |
| sugar pillEligible patients will be randomized and be given 25 mcg of levothyroxine or identical placebo tablet at the beginning of the enrollment. The dosage of drug will subsequently be individualized for each patients according to Serum levels of TSH and FT4 which will be checked initially and then every 6 weeks until the end of the study. The investigators will attempt to maintain TSH levels between (0.25-2.5) mU/l which is the lower half of normal range by adding or reducing the dose of medication. Advice given to patient regarding whether to increase or decrease the dose of medications will be based on patient TSH level according to study protocol. | Drug | sugar pill |
Primary outcome
Effect of the treatment of subclinical hypothyroidism on the apnea hypopnea index (AHI) score.
Time frame: 24 weeks
1 secondary outcome
Effect of the treatment of subclinical hypothyroidism on the lipid profile in patient with dyslipidemia and on hs-CRP
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing levothyroxine and sugar pill in people with Dyslipidemia, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anwar A Jammah, MD, FACP, FRCP ((+966) 1 467-7555, drjammah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the treatment of subclinical hypothyroidism on the apnea hypopnea index (AHI) score. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2011.