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Cardiopulmonary Capacity in Elderly With Different Ranges of Serum Thyroid Stimulating Hormone

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ClinicalTrials.gov Identifier: NCT01849861
Recruitment Status : Unknown
Verified May 2013 by Dhianah Santini de Oliveira Chachamovitz, Universidade Federal do Rio de Janeiro.
Recruitment status was:  Recruiting
First Posted : May 9, 2013
Last Update Posted : May 13, 2013
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Dhianah Santini de Oliveira Chachamovitz, Universidade Federal do Rio de Janeiro

Study Description
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Brief Summary:
The purpose of this study is to correlate in an elderly population (≥ 65 years), the different levels of serum TSH, with cardiopulmonary capacity, quality of life, depressive symptoms and cognition. And assess whether the increased serum TSH to the upper half of the normal range, through the use of antithyroid drugs, is associated with improvements in these parameters.

Condition or disease Intervention/treatment Phase
Healthy Drug: Methimazole Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cardiopulmonary Capacity In Different Quartiles Ranges Of Reference For Serum Thyroid Stimulating Hormone (TSH): Sectional Evaluation And Effect Of The Use Of Methimazole In Elderly Population
Study Start Date : September 2011
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Methimazole

Arms and Interventions
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Arm Intervention/treatment
Experimental: Methimazole,

Patients with serum TSH initially on the 1st. Quartile (TSH: 0.4 to 1.0 mIU / ml) will receive treatment with Methimazole (initial dose of 5mg/day) with the goal of raising the TSH values to range between 2.0 and 4.0 mIU / ml (the half upper range of normal).

After six months with TSH in the target range (2.0 and 4.0 mIU / ml), these patients will be subjected to the same examination protocol performed at baseline and assessed to the effects of treatment on outcome variables.

Variables considered in this study:

  • TSH and FT4
  • Questionnaire of Quality of life for older adults (WHOQOL-OLD)
  • Mini-Mental State Examination
  • Geriatric Depression Scale
  • Cardiopulmonary exercise testing - cardiopulmonary capacity
 Drug: Methimazole

Patients with serum TSH initially on the 1st. Quartile (TSH: 0.4 to 1.0 mIU / ml) will receive treatment with Methimazole (initial dose of 5mg/day) with the goal of raising the TSH values to range between 2.0 and 4.0 mIU / ml (the half upper range of normal).

After six months with TSH in the target range (2.0 and 4.0 mIU / ml), these patients will be subjected to the same examination protocol performed at baseline and assessed to the effects of treatment on outcome variables.

Variables considered in this study:

  • TSH and FT4
  • Questionnaire of Quality of life for older adults (WHOQOL-OLD)
  • Mini-Mental State Examination
  • Geriatric Depression Scale
  • Cardiopulmonary exercise testing - cardiopulmonary capacity
Other Name: a single group


Outcome Measures
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Primary Outcome Measures :
  1. Correlate in a population of more than 65 years old, the different levels of serum TSH, with cardiopulmonary capacity and these effects from baseline after treatment with antithyroid drugs [ Time Frame: six months ]

    Describe the cardiopulmonary capacity in elderly health population of 65 years old or more, in different quartiles of normal range for serum TSH.

    • Assess the outcome in the cardiopulmonary capacity in seniors aged 65 years old or more, in different quartiles of normal range for serum TSH.
    • Quantify the possible changes from baseline related to the use of antithyroid drugs in cardiopulmonary capacity in patients aged 65 or more, with the initial serum TSH at the lower limit of the normal range (1.0 mIU/ml)to values of TSH more than 2.0mUI/ml for six months.


Secondary Outcome Measures :
  1. Assess the quality of life in seniors aged 65 years old or older, in different quartiles of normal range for serum TSH and these changes from baseline after use of methimazole [ Time Frame: six months ]

    Describe the quality of life in elderly health population of 65 years old or more, in different quartiles of normal range for serum TSH.

    • Assess the outcome in quality of life in seniors aged 65 olde or more, in different quartiles of normal range for serum TSH
    • Quantify the possible changes from baseline related to the use of antithyroid drugs in quality of life in patients aged 65 or more, with the initial serum TSH at the lower limit of the normal range (1.0 mIU/ml)to values of TSH more than 2.0mUI/ml for six months..

  2. Assess the mini mental health status in seniors aged 65 years old or older, in different quartiles of normal range for serum TSH and these changes from baseline after use of methimazole [ Time Frame: six months ]

    Describe the mini mental health status in elderly health population of 65 years old or more, in different quartiles of normal range for serum TSH.

    • Assess the outcome in mini mental health status in seniors aged 65 olde or more, in different quartiles of normal range for serum TSH.
    • Quantify the possible changes from baseline related to the use of antithyroid drugs in mini mental health status in patients aged 65 or more, with the initial serum TSH at the lower limit of the normal range (1.0 mIU/ml)to values of TSH more than 2.0mUI/ml for six months.

  3. Assess the depression scale in seniors aged 65 years old or older, in different quartiles of normal range for serum TSH and these changes from baseline after use of methimazole [ Time Frame: six months ]

    Describe the depression scale in elderly health population of 65 years old or more, in different quartiles of normal range for serum TSH.

    • Assess the outcome in depression scale in seniors aged 65 olde or more, in different quartiles of normal range for serum TSH.
    • Quantify the possible changes from baseline related to the use of antithyroid drugs in the depression scale in patients aged 65 years old or more, with the initial serum TSH at the lower limit of the normal range (1.0 mIU/ml)to values of TSH more than 2.0mUI/ml for six months..


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥ 65 years.
  • Healthy Men and women
  • Registration at the University Hospital Clementino Fraga Filho (HUCFF).

Exclusion Criteria:

  • Hypothalamic-pituitary disease
  • Congestive cardiac insufficiency, chronic renal failure, acute renal failure, stroke, chronic obstructive pulmonary disease, asthma, cancer and / or cirrhosis.
  • Diseases of the aorta, peripheral vascular disease, coronary artery disease (including angina, history of prior myocardial infarction or angina, or history of cardiac catheterization and angioplasty).
  • Use of corticosteroids, amiodarone or dopamine, as well as any drug that interferes with the levels of thyroid hormones and / or thyroid function.
  • Use of drugs that interfere with autonomic adaptation mechanism, such as beta-blockers, prolopa and calcium channel blockers. Hypertensive patients without use of such drugs may be included.
  • Patients bedridden, wheelchair or with physical limitations (joint and muscle) to prevent the standing position for at least 20 minutes and the realization of the cardiopulmonary exercise test.
  • Obesity with a body mass index equal or greater than 35 kg/m2.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849861


Contacts
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Contact: Dhiãnah SO Chachamovitz +552126203063 dhianahsantini@gmail.com
Contact: Patrícia de Fátima S Teixeira +552125622748 pfatima@hucff.ufrj.br

Locations
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Brazil
Universidade Federal do Rio de Janeiro Recruiting
Rio de Janeiro, Brazil, 21941-590
Contact: Dhiãnah SO Chachamovitz, MD    +552126203063    dhianahsantini@gmail.com   
Contact: Patrícia de Fátima S Teixeira, MD, PhD    +552125622748    pfatima@hucff.ufrj.br   
Principal Investigator: Dhiãnah SO Chachamovitz, MD         
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: Dhiãnah SO Chachamovitz Universidade Federal do Rio de Janeiro
More Information
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Responsible Party: Dhianah Santini de Oliveira Chachamovitz, Principal Investigator, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01849861     History of Changes
Other Study ID Numbers: idosos01
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: May 2013

Keywords provided by Dhianah Santini de Oliveira Chachamovitz, Universidade Federal do Rio de Janeiro:
Cardiopulmonary Capacity
Ranges of TSH
Elderly Population

Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs