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Antipsychotic Medicine and Metabolic Syndrome (AMMS1)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University Hospital, Gentofte, Copenhagen
University of Copenhagen
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00627757
First received: February 22, 2008
Last updated: July 29, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition
Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Changes in Enteroendocrine and Neuroendocrine Axes in Patients With Weight Gain After Treatment With Antipsychotics

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

Biospecimen Retention:   Samples Without DNA

whole blood, serum, plasma


Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Food challenge test

Patients

51 patients included
C
Controls 93 healthy controls are included

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

50 patients and 100 control persons. Patients should be treated with minimum one antipsychotic drug and hospitalized or treated as out-patients at Glostrup, Ballerup or Gentofte hospitals.

Controls will be chosen from the database at Institute of Health and Prevention, Glostrup.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627757

Contacts
Contact: Henrik Lublin, MD DMSc 045-43233540 henlub01@glo.regionh.dk

Locations
Denmark
Psychiatric University Center Glostrup Recruiting
Copenhagen, Glostrup, Denmark, 2600
Contact: Henrik Lublin, MD DMSc     045-43233540     henlub01@glo.regionh.dk    
Principal Investigator: Henrik Lublin, MD DMSc            
Psychiatric University Center Glostrup Not yet recruiting
Copenhagen, Glostrup, Denmark, 2600
Contact: Henrik Lublin, MD DMSc     045-43233540     henlub01@glo.regionh.dk    
Principal Investigator: Henrik Lublin, MD DMSc            
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
University Hospital, Gentofte, Copenhagen
University of Copenhagen
Investigators
Principal Investigator: Henrik Lublin, MD DMSc Glostrup University Hospital, Copenhagen
  More Information

No publications provided

Responsible Party: Henrik Lublin MD DMSc, Chairman and Associate Pofessor of Psychiatry, Psychiatric University Center Glostrup Copenhagen University Hospitals
ClinicalTrials.gov Identifier: NCT00627757     History of Changes
Other Study ID Numbers: HC-2007-0069, 2602-706
Study First Received: February 22, 2008
Last Updated: July 29, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency

Keywords provided by Glostrup University Hospital, Copenhagen:
metabolic syndrome
weight gain
antipsychotic drugs
Metabolic syndrome and treatment with antipsychotic drugs

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 17, 2013