Clinical trial NCT00627757: Antipsychotic Medicine and Metabolic Syndrome
Official title: Changes in Enteroendocrine and Neuroendocrine Axes in Patients With Weight Gain After Treatment With Antipsychotics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
weight gain
antipsychotic drugs
Metabolic syndrome and treatment with antipsychotic drugs
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
name: University of Copenhagen
First posted: 2008-03-03
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Psychiatric University Center Glostrup
state: Glostrup
city: Copenhagen
country: Denmark
facility: Psychiatric University Center Glostrup
state: Glostrup
Study officials:
affiliation: Glostrup University Hospital, Copenhagen
name: Henrik Lublin, MD DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.