Antipsychotic Medicine and Metabolic Syndrome (AMMS1)

July 29, 2010 updated by: Glostrup University Hospital, Copenhagen

Changes in Enteroendocrine and Neuroendocrine Axes in Patients With Weight Gain After Treatment With Antipsychotics

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
    • Glostrup
      • Copenhagen, Glostrup, Denmark, 2600
        • Recruiting
        • Psychiatric University Center Glostrup
        • Contact:
        • Principal Investigator:
          • Henrik Lublin, MD DMSc
      • Copenhagen, Glostrup, Denmark, 2600
        • Not yet recruiting
        • Psychiatric University Center Glostrup
        • Contact:
        • Principal Investigator:
          • Henrik Lublin, MD DMSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Food challenge test

Patients

51 patients included
C
Controls 93 healthy controls are included

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glostrup University Hospital, Copenhagen

Collaborators

University of Copenhagen
University Hospital, Gentofte, Copenhagen

Investigators

  • Principal Investigator: Henrik Lublin, MD DMSc, Glostrup University Hospital, Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

February 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

February 22, 2008

First Submitted That Met QC Criteria

February 29, 2008

First Posted (Estimate)

March 3, 2008

Study Record Updates

Last Update Posted (Estimate)

July 30, 2010

Last Update Submitted That Met QC Criteria

July 29, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC-2007-0069
  • 2602-706

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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