Clozapine Induced Weight Gain
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|ClinicalTrials.gov Identifier: NCT03996356|
Recruitment Status : Not yet recruiting
First Posted : June 24, 2019
Last Update Posted : June 24, 2019
|Condition or disease||Intervention/treatment|
|Weight Gain Antipsychotic Agents Pharmacogenetics||Other: No study intervention - observational study|
|Study Type :||Observational|
|Estimated Enrollment :||160 participants|
|Official Title:||Clozapine Induced Weight Gain: A Pharmacogenetic Study|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||October 2021|
- Other: No study intervention - observational study
This is an observational study where the comparative groups will be determined by the genetic variants (SNPs) of subjects and not an intervention, per se.
- Body-mass index (BMI) [ Time Frame: 12 months ]BMI will be calculated by weight (kg)/ height^2 (m^2).
- Leptin gene promoter region single nucleotide polymorphisms (SNPs) (rs7799039) [ Time Frame: 12 months ]SNPs will be determined by polymerase chain reaction followed by restriction fragment length polymorphism analysis to determine (c.-2548G or c.-2548A) .
- Serotonin 5-HT 2C receptor gene single nucleotide polymorphisms (SNPs) (rs3813929) [ Time Frame: 12 months ]SNPs will be determined by polymerase chain reaction followed by restriction fragment length polymorphism analysis to determine (c.-759C or c.-759T) .
- Blood haemoglobin A1c concentration [ Time Frame: 6 months ]Haemoglobin A1c concentrations will be determined by ion-exchange HPLC (G8, Tosoh, Amsterdam, Netherlands)
- Waist:hip ratio [ Time Frame: 12 months ]Waist:hip ratio will be calculated by waist circumference (cm)/hips circumference (cm)
- Lipid profile [ Time Frame: 12 months ]Serum lipid profiles will include total cholesterol, HDL cholesterol, LDL cholesterol and triglyceride. These will be measured by enzymatic colorimetric methods on cobas-Roche analysers (Roche, Burges Hill, UK) except LDL cholesterol, which will be calculated using the Friedewald equation ([LDL cholesterol] = [Total cholesterol] - ([Triglyceride] / 2.2) - [HDL cholesterol]
- Clozapine side effects assessment by Clinical Global Impression (CGI) scale [ Time Frame: 12 months ]Clinical Global Impression (CGI) scale is a validated tool to assess clozapine side effects (Ref: Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. 1976. Rockville,MD, U.S. Department of Health, Education, and Welfare)
- Clozapine:nor clozapine ratio [ Time Frame: 12 months ]Clozapine:nor clozapine ratio is calculated by clozapine (ug/L)/ nor clozapine (ug/L) both measured by high-performance liquid chromatography with diode-array detection.
Biospecimen Retention: Samples With DNA
4 blood samples to be taken at 0 and 6 months (2x EDTA plasma/whole blood, 2x serum).
Biochemical markers and status of 2 common single nucleotide polymorphisms will be measured.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996356
|Contact: Brian P Tennant, PhD||(+44)email@example.com|
|Contact: Rhian Beynon, MScfirstname.lastname@example.org|
|Principal Investigator:||Brian P Tennant, PhD||Cwm Taf Morgannwg UHB|