Metformin in Longevity Study (MILES).

NCT02432287 | Completed Phase 4 Results DMC

• 1 other identifier: 2014-3444
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known beneficial effects on glucose metabolism. Evidence from animal models and in vitro studies suggest that in addition to its effects on glucose metabolism, metformin may influence metabolic and cellular processes associated with the development of age-related conditions, such as inflammation, oxidative damage, diminished autophagy, cell senescence and apoptosis. As such, metformin is of particular interest in clinical translational research in aging since it may influence fundamental aging factors that underlie multiple age-related conditions. The investigators therefore propose a pilot study to examine the effect of metformin treatment on the biology of aging in humans. Namely, whether treatment with metformin will restore the gene expression profile of older adults with impaired glucose tolerance (IGT) to that of young healthy subjects.

Conditions

Aging

Keywords

aging; metformin; prediabetes

Outcome Measures

Primary Outcomes (1)

• Increase in Number of Expressed Genes in Muscle and Adipose Tissue Using RNA Sequencing (RNA-Seq)

  The investigators hypothesize that treatment with metformin will result in changes in the transcriptome. The investigators will test this by identifying increases in gene expression in muscle and adipose tissue with RNA Sequencing (RNA-Seq) in metformin and in placebo.

  6 weeks

Secondary Outcomes (1)

• Mixed Meal Tolerance. Assessment of Insulin Sensitivity and Insulin Secretion (Using a Modification of the Matsuda Index)

  6 weeks

Study Arms (2)

Metformin

EXPERIMENTAL

Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known beneficial effects on glucose metabolism.

Drug: Metformin

Placebo

EXPERIMENTAL

Placebo

Drug: Placebo

Interventions

Metformin DRUG

To determine if treatment with metformin (1700 mg/day) will restore the gene expression profile of older, glucose intolerant adults to that of young healthy subjects.

Also known as: Glucophage

Metformin

Placebo DRUG

there is no other name we used for the placebo

Also known as: no others

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women;
• age \>60 years with IGT based on 75g OGTT (fasting plasma glucose \< 126 mg/dl, 2-hr glucose between 140 - 199 mg/dl);
• this definition of IGT will include individuals with combined impaired fasting glucose (IFG) and IGT.

You may not qualify if:

• Serious chronic or acute illness: cancer, clinically significant congestive heart failure, COPD, inflammatory conditions, serum creatinine \> 1.4 mg/dl (female) or \> 1.5 mg/dl (male), active liver disease, history of metabolic acidosis, poorly controlled hypertension, epilepsy, recent (within 3 months) CVD event (MI, PTCA, CABG, stroke); history of bariatric or other gastric surgery, cigarette smoking, binge alcohol use (\>7 drinks in 24 hrs).
• Treatment with drugs known to influence glucose metabolism (other diabetes medications, systemic glucocorticoids, pharmacologic doses of niacin)
• Hypersensitivity to metformin or any component of the formulation

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

Einstein College of Medicine of Yeshiva University

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Limitations and Caveats

Limitations: Crossover design may lead to a carryover effect that was not detected due to small sample size. The sample size was small and certain genes that were differentially expressed may not have been detected.

Results Point of Contact

• Title: Erika Brutsaert
• Organization: Albert Einstein College of Medicine

erika.brutsaert@einstein.yu.edu

7188397961

Study Officials

• Jill Crandall, MD

  Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: May 4, 2015
• Study Start: October 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2017
• Last Updated: May 21, 2021
• Results First Posted: May 31, 2018

Record last verified: 2021-05

Locations

US (1)