Antipsychotic Medicine and Metabolic Syndrome (AMMS1)

G

Glostrup University Hospital, Copenhagen

Status

Unknown

Conditions

Metabolic Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT00627757
2602-706
HC-2007-0069

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Male

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Food challenge test
Description:
Patients 51 patients included
C
Description:
Controls 93 healthy controls are included

Trial contacts and locations

0

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Central trial contact

Henrik Lublin, MD DMSc

Data sourced from clinicaltrials.gov

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