Antipsychotic Medicine and Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— AMMS1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00627757
• Other study ID #: HC-2007-0069
• Secondary ID: 2602-706
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2008
• Last updated: July 29, 2010
• Start date: February 2008
• Est. completion date: December 2010

Study information

• Verified date: July 2010
• Source: Glostrup University Hospital, Copenhagen
• Contact: Henrik Lublin, MD DMSc
• Phone: 045-43233540
• Email: henlub01[@]glo.regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Medicines Agency
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Locations

Country	Name	City	State
Denmark	Psychiatric University Center Glostrup	Copenhagen	Glostrup
Denmark	Psychiatric University Center Glostrup	Copenhagen	Glostrup

Sponsors (3)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	University Hospital, Gentofte, Copenhagen, University of Copenhagen

Country where clinical trial is conducted

Denmark,