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Study of Acarbose in Longevity

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Montefiore Medical Center

关键词

抽象

The investigators are studying the effects of acarbose on muscle and adipose gene transcription in older adults.

描述

Acarbose, an FDA approved drug for the treatment of type 2 diabetes, has known effects on glucose metabolism. Evidence from mice indicates that acarbose may prolong lifespan. In humans, acarbose improves inflammatory markers and reduces cardiovascular events. Consequently, acarbose is of interest in clinical translational aging research since it may influence fundamental processes that contribute to age-related diseases. The study described herein is an exploratory study to examine the effect of acarbose treatment on the biology of aging in humans. Specifically, the investigators plan to study whether treatment with a 10 week course of acarbose will alter the gene expression profile in adipose tissue and muscle in older adults in pathways that are known to be affected by human aging, in a placebo-controlled crossover study.

日期

最后验证: 06/30/2020
首次提交: 09/08/2016
提交的预估入学人数: 10/30/2016
首次发布: 11/01/2016
上次提交的更新: 07/12/2020
最近更新发布: 07/14/2020
实际学习开始日期: 11/21/2016
预计主要完成日期: 12/25/2019
预计完成日期: 12/25/2019

状况或疾病

Aging

干预/治疗

Drug: Acarbose

Other: Placebo

相 2

手臂组

干预/治疗
Other: Acarbose first
Participants will take acarbose three times daily for 10 weeks (titration over 4 weeks, maintenance 6 weeks). After a two week washout, participants will take placebo three times daily for a total of 10 weeks (titration over 4 weeks, maintenance 6 weeks).
Other: Placebo first
Participants will take placebo three times daily for 10 weeks (titration over 4 weeks, maintenance 6 weeks). After a two week washout, participants will take acarbose three times daily for a total of 10 weeks (titration over 4 weeks, maintenance 6 weeks).

资格标准

有资格学习的年龄 60 Years 至 60 Years
有资格学习的性别Male
接受健康志愿者
标准

Inclusion Criteria:

- Male

- age >60 years

- impaired fasting glucose (IFG) or impaired glucose tolerance (IGT)

Exclusion Criteria:

- cancer

- heart failure

- COPD

- inflammatory conditions

- eGFR<45

- active liver disease

- poorly controlled hypertension

- epilepsy

- recent cardiovascular disease event (last 6 months)

- inflammatory bowel disease

- history of bariatric or other gastric surgery

- cigarette smoking

- serious substance abuse.

- Treatment with drugs known to influence glucose metabolism

- Hypersensitivity to acarbose or any component of the formulation.

- Treatment with anti-coagulant medications or anti-platelet drugs

结果

主要结果指标

1. Tissue gene expression after placebo vs after acarbose. [10 weeks]

Difference in gene expression in muscle and abdominal adipose tissue (with adjusted p-value less than 0.05, and a fold change greater than 2) using RNA-seq analysis after 10 weeks of acarbose compared to 10 weeks of placebo.

次要成果指标

1. Serum microRNA [10 weeks]

Difference in microRNA expression level (with adjusted p <0.05) after 10 weeks of acarbose compared to 10 weeks of placebo.

2. Fecal microbiome [10 weeks]

Difference in 16s rDNA gene sequence expression level (with adjusted p <0.05) after 10 weeks of acarbose compared to 10 weeks of placebo.

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