Study of Acarbose in Longevity (SAIL)

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 2

Conditions: Aging

Treatments: Drug: Acarbose; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02953093

2016-6933

Details and patient eligibility

About

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

Full description

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.

Enrollment: 10 patients

Sex: Male

Ages: 60 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups

Acarbose first

Other group

Description:

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).

Treatment:

Other: Placebo

Drug: Acarbose

Placebo first

Other group

Description:

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).

Treatment:

Other: Placebo

Drug: Acarbose