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

NCT01849861 | Unknown Phase 4

• 1 other identifier: idosos01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Cardiopulmonary Capacity; Ranges of TSH; Elderly Population

Outcome Measures

Primary Outcomes (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

  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.

  six months

Secondary Outcomes (3)

• 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

  six months

• 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

  six months

• 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

  six months

Study Arms (1)

Methimazole,

EXPERIMENTAL

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

Interventions

Methimazole DRUG

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

Also known as: a single group

Methimazole,

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil

RECRUITING

MeSH Terms

Interventions

Methimazole

Intervention Hierarchy (Ancestors)

Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dhiãnah SO Chachamovitz

  Universidade Federal do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dhiãnah SO Chachamovitz

CONTACT

+552126203063; dhianahsantini@gmail.com

Patrícia de Fátima S Teixeira

CONTACT

+552125622748; pfatima@hucff.ufrj.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: May 9, 2013
• Study Start: September 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 13, 2013

Record last verified: 2013-05

Locations

BR (1)