Metformin for Preventing Frailty in High-risk Older Adults
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|ClinicalTrials.gov Identifier: NCT02570672|
Recruitment Status : Recruiting
First Posted : October 7, 2015
Last Update Posted : December 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Frailty||Drug: Metformin Drug: Placebo||Phase 2|
Physical frailty is a geriatric syndrome that leads to poor health outcomes such as falls, disability, institutionalization, and death. The prevalence of frailty is estimated to be 7-15% among community-dwelling older U.S. adults. The associated costs of frailty were estimated to be more than $18 billion in 2000 and these will continue to increase over the next two decades. Thus, an increasingly frail older population will have major implications for the demand for health care services, including hospital usage, home care, and long-term care.
Data from several studies have suggested strong roles for diabetes and insulin resistance, which are associated with increased inflammation, in the physiological basis of frailty. The investigators' recent epidemiological research with a community-based population of older adults showed that diabetes was the most significant predictor of frailty onset and worsening over time. While the importance of frailty and its impact on an aging U.S. society have been widely recognized, to date there are no effective interventions to prevent or treat frailty. Therefore, the major goal of this study is to test a drug with insulin-sensitizing and anti-inflammatory properties, such as metformin, as a novel intervention for frailty prevention.
The investigators hypothesize that metformin will lead to reduced inflammation and insulin resistance present in older glucose-intolerant subjects and that these changes will consequently prevent the onset and/or progression of frailty in this sub-population of older adults. Subjects with impaired glucose intolerance will be enrolled in this study because this group encompasses approximately 1/3rd of the older population, this group is at increased risk for developing diabetes and frailty, and is the most likely to benefit from a potential anti-inflammatory and insulin-sensitizing intervention.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Actual Study Start Date :||April 2016|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Subjects will be randomized to metformin (titrated up to 1000 mg twice daily, as tolerated)
Subjects will be randomized to metformin titrated to 1000mg twice daily as tolerated.
Placebo Comparator: Placebo
Subjects will be randomized to metformin (titrated up to 1000 mg twice daily, as tolerated) vs. placebo.
Subjects will randomized to placebo will receive placebo
- Frailty composite measure [ Time Frame: 2 years ]Frailty will be defined using validated standardized criteria (Fried et al., J Geron. 2001 Mar;56(3):M146-56). The frailty score will be measured every 6 months as 0 through 5 of the following 5 frailty characteristics: 1) unintentional weight loss (>= 10 pounds) in last year; 2) self reported exhaustion based on the Geriatric Depression Scale item, "Do you feel full of energy?;" 3) muscle weakness based on hand grip strength measurement (standardized cut points are published); 4) slow gait speed based on 10-foot walk (standardized cut points are published); and 5) low physical activity measured in kilocalories/week based on the Minnesota Leisure Time Questionnaire (standardized cutpoints are published).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570672
|Contact: Alicia Conde, M.A.||210-617-5197|
|United States, Texas|
|University of Texas Health Science Center at San Antonio||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Alicia Conde 210-617-5197|
|Principal Investigator:||Sara E Espinoza, M.D.||Associate Professor|