Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability
- Conditions
- Intellectual DisabilityDevelopmental DisabilityObesity
- Registration Number
- NCT05744479
- Lead Sponsor
- Centre for Addiction and Mental Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Stable outpatients<br><br> - Age 18-65 years<br><br> - Diagnosed with IDD<br><br> - On maintenance treatment with an antipsychotic (stable dose for =3 months).<br><br> - BMI must be =30 kg/m2, or =27 kg/m2 with at least one weight-related comorbidity<br> (treated or untreated) such as: hypertension, dyslipidaemia, obstructive sleep<br> apnea, or impaired fasting glucose.<br><br> - Females of child-bearing age must be on one of the following regular contraceptives:<br><br> 1. Agree to abstain from sex for the duration of the trial or<br><br> 2. A barrier method of a diaphragm with spermicide and/or Latex condom or<br><br> 3. An oral contraceptive agent, implantable contraceptive or an injectable<br> contraceptive for at least six months prior to entering the study and will<br> continue its use throughout the study, or<br><br> 4. An intrauterine device, or<br><br> 5. Partner has had a vasectomy at least 3 months prior to study start<br><br>Exclusion Criteria:<br><br> - Females who are nursing, currently pregnant, or have a positive pregnancy test<br><br> - Clinical or laboratory evidence of uncompensated cardiovascular, endocrine,<br> haematological, hepatic, renal, or pulmonary disease<br><br> - Previous treatment and lack of efficacy or tolerability with metformin<br><br> - History or diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (TD2) or fasting<br> blood work, HbA1c > 6.5%<br><br> - History of metabolic acidosis or lactic acidosis<br><br> - Treatment with weight-lowering agents<br><br> - Medications with significant renal impact<br><br> - Major medical or surgical event in the preceding 3 months<br><br> - Acute suicidal risk.<br><br> - Moderate to severe substance use disorder, other than caffein or nicotine use<br> disorder
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Individual's percentage change in body weight
- Secondary Outcome Measures
Name Time Method Proportion of participants who achieve body weight reduction =5%, and =10% in each arm;Between group (metformin vs placebo) absolute change in weight;Between group absolute change in waist circumference;Between group absolute change in BMI;Change in whole body insulin sensitivity calculated with Matsuda Index;Change in beta-cell function, measured using the Insulin Secretion-Sensitivity Index-2 (ISSI-2);Proportion in each group converting to impaired glucose tolerance, prediabetes, or type 2 diabetes;Change in cardiovascular risk factors assessed by change in C-reactive protein;Change in cardiovascular risk factor assessed by change in fasting lipids profile;Change in cardiovascular risk factor assessed by change in blood pressure;Change in visceral and liver fat content;Medication Adherence