ClinicalTrials.gov
ClinicalTrials.gov Menu

Metformin in Longevity Study (MILES). (MILES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02432287
Recruitment Status : Completed
First Posted : May 4, 2015
Results First Posted : May 31, 2018
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Erika Brutsaert, Albert Einstein College of Medicine, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Aging
Interventions: Drug: Metformin
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Metformin First, Then Placebo

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

Participants in the metformin first group took 1-2 metformin capsules 2 times daily for 6 weeks, followed by a 2 week washout period, concluding with 6 weeks of 1-2 placebo capsules (which matched metformin capsules) 2 x daily.

Placebo First, Then Metformin Participants in the placebo first group took 1-2 placebo capsules 2 x daily (which matched metformin capsules) for 6 weeks, followed by a 2 week washout period, concluding with 6 weeks of 1-2 metformin capsules 2x daily.

Participant Flow for 3 periods

Period 1:   First Intervention
    Metformin First, Then Placebo   Placebo First, Then Metformin
STARTED   8   8 
COMPLETED   8   7 
NOT COMPLETED   0   1 

Period 2:   Washout Period
    Metformin First, Then Placebo   Placebo First, Then Metformin
STARTED   7   7 
COMPLETED   7   7 
NOT COMPLETED   0   0 

Period 3:   Second Intervention
    Metformin First, Then Placebo   Placebo First, Then Metformin
STARTED   7   7 
COMPLETED   7   7 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Metformin FIRST, Then Placebo

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

In the metformin first group, individuals took 1700mg/day metformin in 2 doses for 6 weeks, followed by 2 weeks of washout, and concluding with placebo capsules that matched the metformin for 6 weeks.

Placebo FIRST, Then Metformin In the placebo first group, individuals took placebo capsules that matched metformin for 6 weeks, followed by 2 weeks of washout, and concluding with metformin 1700mg/day (in 2 doses) for 6 weeks.
Total Total of all reporting groups

Baseline Measures
   Metformin FIRST, Then Placebo   Placebo FIRST, Then Metformin   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   8   16 
Age 
[Units: Years]
Mean (Standard Deviation)
 69  (6.7)   74  (5.4)   71  (6.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  37.5%      3  37.5%      6  37.5% 
Male      5  62.5%      5  62.5%      10  62.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3  37.5%      1  12.5%      4  25.0% 
White      5  62.5%      7  87.5%      12  75.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   8   8   16 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 28  (3.1)   32  (4.4)   30  (4.3) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 84  (14)   89  (17)   87  (16) 
Fasting glucose 
[Units: mg/dL]
Mean (Standard Deviation)
 108  (13)   102  (10)   105  (12) 
2-hour glucose 
[Units: mg/dL]
Mean (Standard Deviation)
 153  (13)   171  (24)   162  (21) 
Antihypertensive therapy 
[Units: Participants]
Count of Participants
 5   6   11 
Statin therapy 
[Units: Participants]
Count of Participants
 3   3   6 
Aspirin therapy 
[Units: Participants]
Count of Participants
 2   3   5 


  Outcome Measures

1.  Primary:   Increase in Number of Expressed Genes in Muscle and Adipose Tissue Using RNA Sequencing (RNA-Seq)   [ Time Frame: 6 weeks ]

2.  Secondary:   Mixed Meal Tolerance. Assessment of Insulin Sensitivity and Insulin Secretion (Using a Modification of the Matsuda Index)   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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.



  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Erika Brutsaert
Organization: Albert Einstein College of Medicine
phone: 7188397961
e-mail: erika.brutsaert@einstein.yu.edu



Responsible Party: Erika Brutsaert, Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier: NCT02432287     History of Changes
Other Study ID Numbers: 2014-3444
First Submitted: February 24, 2015
First Posted: May 4, 2015
Results First Submitted: December 20, 2017
Results First Posted: May 31, 2018
Last Update Posted: May 31, 2018