NCT03996356

Clozapine Induced Weight Gain

Clozapine Induced Weight Gain: A Pharmacogenetic Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: Cwm Taf University Health Board (NHS) · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Clozapine is prescribed to patients with psychosis in whom other treatments have not worked. Research has shown, however, that clozapine may be associated with weight gain and abnormal blood sugar levels in some patients. There is strong evidence to suggest that genetic variation between individuals plays an important role in the development of these side effects in response to the medication. Our research aims to evaluate the effects of two genes and the blood level of clozapine on side-effects such as weight changes and blood sugar levels in patients receiving clozapine treatment. From out-patient clinics in Cwm Taf UHB, the investigators aim to recruit 160 patients who are taking clozapine; collect information/ measurements from recruits relating to size/ weight/ BMI, risk of diabetes and blood samples to measure markers of blood sugar, fat/lipids, clozapine and its breakdown products, blood cells and variants of two specific genes. From this information the investigators will be particularly interested to understand if there is any association between the variation in these two genes with weight gain or changes in blood sugar, in patients taking clozapine.

Conditions

• Weight Gain
• Antipsychotic Agents
• Pharmacogenetics

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-03-01
• Completion: 2021-10-01
• First posted: 2019-06-24
• Last updated: 2019-06-24

Locations

1 site across 1 country: United Kingdom