Metformin in Co-morbid Diabetes or Prediabetes and Serious Mental Illness
2018年7月27日 更新者：Margaret Hahn、Centre for Addiction and Mental Health
Schizophrenia is associated with a lifespan shortened by 20 years, due to cardiovascular disease (CVD), with antipsychotic (AP) medications understood to contribute to this risk through associated metabolic side-effects.
Metformin, a medication used to treat prediabetes, and diabetes in the general population, holds promise with regard to reduction of AP-related metabolic problems, but has not been directly tested in early episode patients beyond weight loss, nor specifically in patients with diabetes or prediabetes and psychosis.
We propose to replicate findings that metformin can reduce weight gain, and dysglycemia uniquely focusing on an early episode population diagnosed with prediabetes or diabetes.
To help determine long-term risk/benefit of adjunctive metformin, we propose to look at changes in abdominal and liver fat, two well-established risk factors for CVD.
Given links between dysglycemia, obesity with hippocampal volume loss and cognitive dysfunction, we will explore if improvements in metabolic indices are associated in changes in cognition and brain structure.
研究概览
详细说明
This is a 16 week, double-blind, randomized pilot study, which proposes to recruit 24 patients with schizophrenia, or schizoaffective disorders (DSM 5), who are overweight or obese (BMI >25) and have prediabetes or type 2 diabetes.
Randomization occurs on a 2:1 basis, with 16 patients randomised to metformin, and 8 to placebo.
Metfomin/placebo is dispensed monthly.
The baseline and /or screening visit includes a physical exam (including anthropometric measures), medical history, fasting blood work (glucose, insulin, HbA1c, lipids, electrolytes, thyroid, liver/kidney function), in addition to a urine drug screen.
Women of child-bearing age are given a pregnancy test.
Patients who meet inclusion criteria and consent to the study have an oral glucose tolerance test (OGTT), and a baseline abdominal and brain MRI (to respectively assess visceral adiposity, a key risk factor for CV disease, and hippocampal volumes).
Anthropometric measures and pill counts are repeated bi-weekly.
At week 8, fasting insulin/glucose, HbA1C, and liver function tests are measured.
End of study measures (week 16), include the same panel of bloodwork conducted at baseline, as well as a repeat OGTT, and an abdominal and brain MRI.
Rountine psychopathology scales, including BPRS, CGI, and CDS will be measured at baseline, and week 16.
The Brief Assessment of Cognition in Schizophrenia (BACS) will also be completed at baseline, and study end.
研究类型
介入性
注册 (实际的)
35
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ontario
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Toronto、Ontario、加拿大
- Center for Addiction and Mental Health
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
17年 至 45年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients within 5 years of diagnosis of schizophrenia, schizoaffective disorder , or bipolar disorder(DSM V), or those younger than 40 years old, regardless of duration of illness
- Co-morbid diagnosis of prediabetes or diabetes (Canadian or American Diabetes Association criteria)
Exclusion Criteria:
- Patients with co-morbid axis, other than nicotine dependence, or cannabis abuse
- Patients with liver, or renal dysfunction,
- Patients with a positive drug urine screen (other than cannabis or nicotine)
- Females with a positive pregnancy test will be excluded.
- Prior trial with metformin, and reported lack of tolerability
- Patients with an A1C > 9.5%, or symptomatic hyperglycemia with metabolic decompensation
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Metformin
Metformin/ placebo will be dispensed on a biweekly basis, and pill counts conducted at each visit.
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Metformin will be dispensed on a biweekly basis, and pill counts conducted at each visit.
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安慰剂比较：Placebo
Metformin/ placebo will be dispensed on a biweekly basis, and pill counts conducted at each visit.
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Placebo will be dispensed on a biweekly basis, and pill counts conducted at each visit.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improvement in HbA1C derived from Oral glucose tolerance test (Matsuda, index of insulin sensitivity; area under glucose curve; insulin secretion sensitivity index-2 (ISSI-2))
大体时间：3 years
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HbA1c value assessment
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3 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Decreases in visceral adiposity
大体时间：3 years
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Visceral adiposity assessment via MRI
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3 years
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Decreases in hepatic adiposity
大体时间：3 years
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Hepatic adiposity assessment via MRI
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3 years
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Greater than 5% decrease in body weight
大体时间：3 years
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Body weight assessment
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3 years
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Improvements in cognition
大体时间：3 years
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Cognition assessment
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3 years
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Improvements in hippocampal volume
大体时间：3 years
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Cognition assessment
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3 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Margaret Hahn、Center for Addiction and Mental Health
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年6月1日
初级完成 (实际的)
2018年2月1日
研究完成 (实际的)
2018年3月1日
研究注册日期
首次提交
2014年6月17日
首先提交符合 QC 标准的
2014年6月17日
首次发布 (估计)
2014年6月19日
研究记录更新
最后更新发布 (实际的)
2018年7月30日
上次提交的符合 QC 标准的更新
2018年7月27日
最后验证
2018年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Metformin的临床试验
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Poznan University of Medical SciencesUniversity of California, San Diego未知
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Boehringer IngelheimEli Lilly and Company完全的
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Boehringer IngelheimEli Lilly and Company完全的