RecruitingPhase 4NCT05744479

Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability

Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability: A Double-Blind Randomized Control Trial


Sponsor

Centre for Addiction and Mental Health

Enrollment

100 participants

Start Date

Feb 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

People with IDD (intellectual and developmental disability) have very high rates of obesity and die prematurely from cardiometabolic disease. While antipsychotics contribute to this problem, their use is necessary and appropriate in a significant subgroup of individuals with IDD. Exercise and diet interventions have limitations and may not be sufficient, requiring effective adjunctive pharmacological approaches to target obesity and related comorbidities in IDD. However, persons with IDD treated with antipsychotics are systematically excluded from clinical trials hindering development of evidence to help guide safe and effective treatment of these comorbidities. Moreover, evidence from other disorders cannot be extrapolated to IDD given inherent biological differences between disorders. This trial will address the identified gaps, which extend beyond cardiovascular morbidity and negatively impact psychosocial outcomes, in a hugely underserviced population.This is the the first RCT (randomized control trial) to examine the efficacy of metformin in overweight or obese adults with IDD who have experienced antipsychotic-induced weight gain. By generating efficacy data for a very accessible and scalable intervention, allows for guideline and implementation strategies to address a recalcitrant health problem.


Eligibility

Min Age: 16 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether metformin — a widely used and safe diabetes medication — can help prevent or reverse weight gain caused by antipsychotic medications in people with intellectual and developmental disabilities (IDD). Antipsychotic medications are commonly prescribed to manage challenging behaviors in people with IDD, but they often cause significant weight gain, which in turn raises the risk of diabetes, heart disease, and other serious health problems. Metformin is known to counter antipsychotic-related weight gain in the general population, but this hasn't been well studied in people with IDD. Eligible participants must be 16 to 65 years old with an IDD diagnosis, be on a stable antipsychotic regimen for at least 3 months, and have obesity or overweight with related health complications. Women of childbearing age must use appropriate contraception. People with diabetes, metabolic acidosis, serious kidney or liver disease, or a history of unsuccessful metformin treatment are excluded. This research is critically important because people with IDD are among the most vulnerable to medication side effects and the least represented in clinical research. They experience high rates of antipsychotic prescribing and disproportionate rates of obesity-related illness. An effective, accessible, and affordable solution like metformin could dramatically reduce the cardiometabolic burden on this population and improve their long-term health outcomes.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetformin

Metformin oral, 2000mg/day, for 24 weeks.

DRUGPlacebo

Oral placebo for 24 weeks

BEHAVIORALLifestyle Intervention

Participants from both groups will meet a dietician and a diabetes educator at the study start to obtain advice regarding healthy diet, portion size, and meal planning to improve physical health. All participants will be invited to monthly group meetings to learn skills which will help them in a variety of wellness areas such as physical exercises and diet. Attendance in these sessions will be encouraged but not mandatory, and attendance will be recorded. Fidelity with these interventions will be captured using diet and physical activity questionnaires at RCT start, midpoint and end, and end of open label phase.


Locations(1)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

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NCT05744479


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