Study of Acarbose in Longevity

Aging Clinical Trial

— SAIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02953093
• Other study ID #: 2016-6933
• Status: Completed
• Phase: Phase 2
• Start date: August 30, 2017
• Est. completion date: December 26, 2019

Study information

• Verified date: August 2021
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 26, 2019
• Est. primary completion date: April 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Drug:
• Acarbose
see arm description

Other:
• Placebo
See arm description

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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