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Thyroxin Treatment in Sub Clinical Hypothyroidism, on the Apnea Hypopnea Index Score, Lipids and Highly Sensitive CRP

6. Dezember 2011 aktualisiert von: Anwar Ali Jammah, King Saud University

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.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

200

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Saudi-Arabien
      • Riyadh, Saudi-Arabien, 11472
        • Rekrutierung
        • University Sleep Disorders Center
        • Kontakt:
          • Anwar A Jammah, MD, FACP,FRCPC
          • Telefonnummer: (+966 1) 467-11784; 467-9179
          • E-Mail: drjammah@gmail.com
        • Kontakt:
        • Unterermittler:
          • Ahmed S BaHammam, FRCP, FCCP
        • Hauptermittler:
          • Anwar A Jammah, MD, FACP, FRCPC
        • Unterermittler:
          • Muneer S Muhammad

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Zucker Pille
Arzneimittel: sugar pill
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.
Aktiver Komparator: Levothyroxine
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.
Arzneimittel: levothyroxine
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Effect of the treatment of subclinical hypothyroidism on the apnea hypopnea index (AHI) score.
Zeitfenster: 24 weeks
24 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Effect of the treatment of subclinical hypothyroidism on the lipid profile in patient with dyslipidemia and on hs-CRP
Zeitfenster: 24 weeks
24 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

King Saud University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Oktober 2011

Primärer Abschluss (Voraussichtlich)

1. Oktober 2013

Studienanmeldedaten

Zuerst eingereicht

3. Dezember 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Dezember 2011

Zuerst gepostet (Schätzen)

6. Dezember 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

8. Dezember 2011

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Dezember 2011

Zuletzt verifiziert

1. Dezember 2011

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • E-11-465

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