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临床试验/NCT05744479
NCT05744479
招募中
4 期

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

Centre for Addiction and Mental Health1 个研究点 分布在 1 个国家目标入组 100 人2023年2月28日

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.

注册库
clinicaltrials.gov
开始日期
2023年2月28日
结束日期
2027年3月1日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

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)

研究点 (1)

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