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OpenTrials
Completed

NCT Number: NCT00584961

BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder

To assess the prevalence of Metabolic Syndrome in Spanish population with Bipolar I or II Disorder.

To analyse the clinical progress disease in patients with Bipolar I or II Disorder for 12 months using the assessment of the symptoms disease and the progress of metabolic and cardiovascular risk.

To analyse the health status, quality of life and functioning/disability of patients.

Completed

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Metabolic Syndrome Mood Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Consecutive patient sampling. In any investigational site, five consecutive patients with diagnosis of Bipolar Disorder will be enrolled in the study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with diagnosis of Bipolar Disorder (DSM-IV TR)
  • Patients or their legal representatives have provided informed consent

Exclusion criteria

  • Patients are unable to complete or to understand health questionnaires in Spanish language
  • Patients enrolled in clinical trials or other studies

Treatment and study plan

Non-Interventional

Other

non-interventional

Primary outcomes

  1. Evolution of Modifiable Metabolic and Cardiovascular Risk Factors (Weight, and serum levels of Glucose, Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol and Triglycerides)

    Time frame: 12 months

  2. Clinical Evolution of the Disease

    Time frame: 12 months

  3. Cardiovascular Risk

    Time frame: 12 months

Secondary outcomes

  1. Current pattern of treatment in Bipolar Disorder

    Time frame: 12 month

  2. Prevalence of Metabolic Syndrome in Spanish Population with Bipolar Disorder

    Time frame: 1 day

  3. Patient functional impairment

    Time frame: 12 months

  4. Patient quality of life

    Time frame: 12 month

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Acronym: BIMET

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 2, 2008
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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