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Antipsychotic Medicine and Metabolic Syndrome

NCT ID: NCT00627757

Last Updated: 2010-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-12-31

Brief Summary

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The purpose of the study is to determine whether antipsychotic treatment is influence psychiatric patients due to endocrine and metabolic status and a quality of life.

The investigators expect, that 30-50% of patients will show pharmacon - gene induced weight gain (\> 7% of initial bodyweight) while the rest of patients will maintain unaltered bodyweight.

Detailed Description

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The primary aim of this study is to investigate status of neuro-and enteroendocrine axes with focus on beta - cell function in relation to insulin resistance, lipid profile abnormalities and inflammations adipokins in patients during treatment with antipsychotics (AP) in relation to weight gain.

The second aim is to evaluate the connection between weight gain and patients´ own perception of their quality of life and health.

Conditions

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Metabolic Syndrome

Keywords

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metabolic syndrome weight gain antipsychotic drugs Metabolic syndrome and treatment with antipsychotic drugs

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Food challenge test

Patients

51 patients included

No interventions assigned to this group

C

Controls 93 healthy controls are included

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* gender : male
* age: 18-45
* treatment with minimum one Antipsychotic drug (AP)
* ethnicity: caucasians
* consent given to take part in the project

Exclusion Criteria

One criteria is sufficient to exclude patients from the study:

* compliance problems
* unable to read, write and talk Danish
* patients with major lung-,heart-, lever- and kidney problems
* patients with diagnose and treatment for Diabetes 1 and 2
* patients taking cholesterol-reducing, weight-reducing and antihypertensive medication
* patients with abuse of alcohol or drugs
* patients who are under duress §
* patients who have been mentally ill for more than 15 years
* patients with diagnosis/treatment for NIDDM/IDDM
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Psychiatric University Center Glostrup Copenhagen University Hospitals

Principal Investigators

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Henrik Lublin, MD DMSc

Role: PRINCIPAL_INVESTIGATOR

Glostrup University Hospital, Copenhagen

Locations

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Psychiatric University Center Glostrup

Copenhagen, Glostrup, Denmark

Site Status RECRUITING

Psychiatric University Center Glostrup

Copenhagen, Glostrup, Denmark

Site Status NOT_YET_RECRUITING

Countries

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Denmark

Central Contacts

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Henrik Lublin, MD DMSc

Role: CONTACT

Phone: 045-43233540

Email: [email protected]

Facility Contacts

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Henrik Lublin, MD DMSc

Role: primary

Henrik Lublin, MD DMSc

Role: primary

References

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Ebdrup BH, Knop FK, Madsen A, Mortensen HB, Sogaard B, Holst JJ, Szecsi PB, Lublin H. Glucometabolic hormones and cardiovascular risk markers in antipsychotic-treated patients. J Clin Psychiatry. 2014 Sep;75(9):e899-905. doi: 10.4088/JCP.13m08820.

Reference Type DERIVED
PMID: 25295432 (View on PubMed)

Other Identifiers

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2602-706

Identifier Type: -

Identifier Source: secondary_id

HC-2007-0069

Identifier Type: -

Identifier Source: org_study_id