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Metformin in Longevity Study (MILES). (MILES)

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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
Enrollment 16

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Metformin First, Then Placebo Placebo First, Then Metformin
Hide Arm/Group Description

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.

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.
Period Title: First Intervention
Started 8 8
Completed 8 7
Not Completed 0 1
Period Title: Washout Period
Started 7 7
Completed 7 7
Not Completed 0 0
Period Title: Second Intervention
Started 7 7
Completed 7 7
Not Completed 0 0
Arm/Group Title Metformin FIRST, Then Placebo Placebo FIRST, Then Metformin Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 16 participants
69  (6.7) 74  (5.4) 71  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
3
  37.5%
3
  37.5%
6
  37.5%
Male
5
  62.5%
5
  62.5%
10
  62.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 16 participants
8
 100.0%
8
 100.0%
16
 100.0%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 8 participants 8 participants 16 participants
28  (3.1) 32  (4.4) 30  (4.3)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 8 participants 8 participants 16 participants
84  (14) 89  (17) 87  (16)
Fasting glucose  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 8 participants 8 participants 16 participants
108  (13) 102  (10) 105  (12)
2-hour glucose  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 8 participants 8 participants 16 participants
153  (13) 171  (24) 162  (21)
Antihypertensive therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
5
  62.5%
6
  75.0%
11
  68.8%
Statin therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
3
  37.5%
3
  37.5%
6
  37.5%
Aspirin therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
2
  25.0%
3
  37.5%
5
  31.3%
1.Primary Outcome
Title Increase in Number of Expressed Genes in Muscle and Adipose Tissue Using RNA Sequencing (RNA-Seq)
Hide Description 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.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Treatment Placebo Treatment
Hide Arm/Group Description:

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

Participants took metformin (1700 mg/day) for 6 weeks, followed by a 2 week washout, concluding with placebo pills (that matched metformin) for 6 weeks.

Participants took placebo that matched metformin for 6 weeks.
Overall Number of Participants Analyzed 14 14
Measure Type: Number
Unit of Measure: genes
genes increased in muscle 245 402
genes increased in adipose 15 132
2.Secondary Outcome
Title Mixed Meal Tolerance. Assessment of Insulin Sensitivity and Insulin Secretion (Using a Modification of the Matsuda Index)
Hide Description Assessment of insulin sensitivity and insulin secretion. Insulin sensitivity will be estimated from insulin and glucose levels obtained following the standard meal challenge, using a modification of the Matsuda index, which has been widely used for non-invasive assessment of insulin sensitivity and shows good correlation (r=0.73) with results obtained from euglycemic hyperinsulinemic clamp studies. A higher Matsuda index indicates better insulin sensitivity. The insulin sensitivity index (ISI (comp) was calculated using the following equation (where g denotes glucose at various time points and i denotes insulin at various time points): ISI (comp)= 10000/ ((g0*i0* ((g0*15+ g30*30+ g60*30+ g90*30+ g120*30+ g180*30+ g240*15)/240))* ((i0*15+ i30*30+ i60*30+ i90*30*+ i120*30+ i180*30+ i240*15)/240))^0.5
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Treatment Placebo Treatment
Hide Arm/Group Description:

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

During metformin treatment, individuals took 1700mg/day metformin in 2 doses for 6 weeks.

During the placebo treatment, individuals took placebo capsules that matched metformin for 6 weeks.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: index
5.6  (3.9) 4.1  (2.1)
Time Frame Adverse event data were collected during the study period of 14 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metformin Placebo
Hide Arm/Group Description

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

Participants took metformin capsules 2 times daily for 6 weeks.

All participants took placebo capsules 2 x daily for 6 weeks.
All-Cause Mortality
Metformin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/15 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Metformin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      0/15 (0.00%)    
Gastrointestinal disorders     
Nausea and vomiting * [1]  1/15 (6.67%)  1 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Hematoma * [2]  1/15 (6.67%)  1 0/15 (0.00%)  0
Renal and urinary disorders     
urinary retention * [3]  1/15 (6.67%)  1 0/15 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Participant developed nausea and vomiting after taking opiate analgesic for hematoma
[2]
Hematoma of thigh after muscle biopsy.
[3]
Participant developed urinary retention during study treatment requiring foley catheter placement.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metformin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      2/15 (13.33%)    
Cardiac disorders     
Chest pain * [1]  0/15 (0.00%)  0 1/15 (6.67%)  1
Skin and subcutaneous tissue disorders     
Shingles * [2]  0/15 (0.00%)  0 1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Participant developed an episode of 4 minutes of chest pain and palpitations during study treatment.
[2]
Participant developed shingles during study

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.

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
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