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Clozapine Induced Weight Gain

NCT03996356 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2019-06-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Cwm Taf University Health Board (NHS)

    lead OTHER_GOV

Principal Investigators

  • Brian P Tennant, PhD · Cwm Taf Morgannwg UHB

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2021-03-31
Completion
2021-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03996356 on ClinicalTrials.gov