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 21, 2021
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 8 participants | 8 participants | 16 participants | |
Female |
3 37.5%
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3 37.5%
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6 37.5%
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Male |
5 62.5%
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5 62.5%
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10 62.5%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 8 participants | 16 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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|
Asian |
0 0.0%
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0 0.0%
|
0 0.0%
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|
Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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|
Black or African American |
3 37.5%
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1 12.5%
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4 25.0%
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White |
5 62.5%
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7 87.5%
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12 75.0%
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|
More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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|
Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 8 participants | 8 participants | 16 participants |
8 100.0%
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8 100.0%
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16 100.0%
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BMI
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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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 |
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Number Analyzed | 8 participants | 8 participants | 16 participants | |
84 (14) | 89 (17) | 87 (16) | ||
Fasting glucose
Mean (Standard Deviation) Unit of measure: mg/dL |
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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 |
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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%
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6 75.0%
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11 68.8%
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Statin therapy
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 8 participants | 16 participants | |
3 37.5%
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3 37.5%
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6 37.5%
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Aspirin therapy
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 8 participants | 16 participants | |
2 25.0%
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3 37.5%
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5 31.3%
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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.
Name/Title: | Erika Brutsaert |
Organization: | Albert Einstein College of Medicine |
Phone: | 7188397961 |
EMail: | erika.brutsaert@einstein.yu.edu |
Responsible Party: | Albert Einstein College of Medicine |
ClinicalTrials.gov Identifier: | NCT02432287 |
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 21, 2021 |