Study of Acarbose in Longevity

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

Detailed Description
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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.

Official Title
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Study of Changes in Muscle and Fat Gene Transcription With Acarbose Treatment: a Crossover Study

Conditions
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Aging

Intervention / Treatment
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* Drug: Acarbose
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Acarbose first<br>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). | Drug: Acarbose<br>* see arm description<br>* Other names: Precose;Other: Placebo<br>* See arm description<br>|
| Other: Placebo first<br>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). | Drug: Acarbose<br>* see arm description<br>* Other names: Precose;Other: Placebo<br>* See arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue gene expression after placebo vs after acarbose. | 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. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum microRNA | Difference in microRNA expression level (with adjusted p <0.05) after 10 weeks of acarbose compared to 10 weeks of placebo. | 10 weeks | 
| Fecal microbiome | Difference in 16s rDNA gene sequence expression level (with adjusted p <0.05) after 10 weeks of acarbose compared to 10 weeks of placebo. | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acarbose, aging