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

Last updated: August 19, 2024
Sponsor: Centre for Addiction and Mental Health
Overall Status: Active - Recruiting

Phase

4

Condition

Obesity

Sjögren-larsson Syndrome

Birth Defects

Treatment

Lifestyle Intervention

Metformin

Placebo

Clinical Study ID

NCT05744479
024/2022
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Stable outpatients

  • Age 18-65 years

  • Diagnosed with IDD

  • On maintenance treatment with an antipsychotic (stable dose for ≥3 months).

  • BMI must be ≥30 kg/m2, or ≥27 kg/m2 with at least one weight-related comorbidity (treated or untreated) such as: hypertension, dyslipidaemia, obstructive sleepapnea, or impaired fasting glucose.

  • Females of child-bearing age must be on one of the following regular contraceptives:

  1. Agree to abstain from sex for the duration of the trial or

  2. A barrier method of a diaphragm with spermicide and/or Latex condom or

  3. An oral contraceptive agent, implantable contraceptive or an injectablecontraceptive for at least six months prior to entering the study and willcontinue its use throughout the study, or

  4. An intrauterine device, or

  5. Partner has had a vasectomy at least 3 months prior to study start

Exclusion

Exclusion Criteria:

  • Females who are nursing, currently pregnant, or have a positive pregnancy test

  • Clinical or laboratory evidence of uncompensated cardiovascular, endocrine,haematological, hepatic, renal, or pulmonary disease

  • Previous treatment and lack of efficacy or tolerability with metformin

  • History or diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (TD2) or fastingblood work, HbA1c > 6.5%

  • History of metabolic acidosis or lactic acidosis

  • Treatment with weight-lowering agents

  • Medications with significant renal impact

  • Major medical or surgical event in the preceding 3 months

  • Acute suicidal risk.

  • Moderate to severe substance use disorder, other than caffein or nicotine usedisorder

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Lifestyle Intervention
Phase: 4
Study Start date:
February 28, 2023
Estimated Completion Date:
December 01, 2026

Connect with a study center

  • Centre for Addiction and Mental Health

    Toronto, Ontario M6J1H3
    Canada

    Active - Recruiting

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