Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability: A Double-Blind Randomized Control Trial
概览
- 阶段
- 4 期
- 干预措施
- Metformin
- 疾病 / 适应症
- Intellectual Disability
- 发起方
- Centre for Addiction and Mental Health
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Individual's percentage change in body weight
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
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.
研究者
入排标准
入选标准
- •Stable outpatients
- •Age 16-65 years
- •Diagnosed with an 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 sleep apnea, or impaired fasting glucose, OR \>=25 for individuals who have gained \> 5% body weight in association with AP use.
- •Females of child-bearing age must be on one of the following regular contraceptives:
- •Agree to abstain from sex for the duration of the trial or
- •A barrier method of a diaphragm with spermicide and/or Latex condom or
- •An oral contraceptive agent, implantable contraceptive or an injectable contraceptive for at least six months prior to entering the study and will continue its use throughout the study, or
- •An intrauterine device, or
排除标准
- •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 fasting blood 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 use disorder
研究组 & 干预措施
Metformin (Oral)
50 participants will be administered oral metformin titrated to a maximum dose of 2000mg/day for 24 weeks.
干预措施: Metformin
Metformin (Oral)
50 participants will be administered oral metformin titrated to a maximum dose of 2000mg/day for 24 weeks.
干预措施: Lifestyle Intervention
Placebo
50 participants will be administered an identical oral placebo for 24 weeks.
干预措施: Placebo
Placebo
50 participants will be administered an identical oral placebo for 24 weeks.
干预措施: Lifestyle Intervention
结局指标
主要结局
Individual's percentage change in body weight
时间窗: Weeks 0, 4, 8, 12, 16, 10, 24
Percentage change in body weight measured in percentage change of pounds (lbs)
次要结局
- Proportion of participants who achieve body weight reduction ≥5%, and ≥10% in each arm(Week 0 and week 24)
- Between group (metformin vs placebo) absolute change in weight(Week 24)
- Between group absolute change in waist circumference(Week 24)
- Between group absolute change in BMI(Week 24)
- Change in whole body insulin sensitivity calculated with Matsuda Index(Week 0 and Week 24)
- Change in visceral and liver fat content(Week 0 and Week 24)
- Medication Adherence(Week 0 to Week 24)
- Change in beta-cell function, measured using the Insulin Secretion-Sensitivity Index-2 (ISSI-2)(Week 0 and Week 24)
- Proportion in each group converting to impaired glucose tolerance, prediabetes, or type 2 diabetes(Week 0 and Week 24)
- Change in cardiovascular risk factors assessed by change in C-reactive protein(Week 0 and Week 24)
- Change in cardiovascular risk factor assessed by change in fasting lipids profile(Week 0 and Week 24)
- Change in cardiovascular risk factor assessed by change in blood pressure(Week 0 and Week 24)