Peripheral Arterial Disease Clinical Trial
Official title:
Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study of Metformin for the Assessment of Changes in Functional Capacity, Endothelial Function, and Hemodynamics in Individuals With Peripheral Artery Disease-Related Intermittent Claudication
The purpose of this study is to determine the effects of metformin on functional capacity (pain-free and maximum walking times) in individuals with peripheral artery disease (PAD)-related intermittent claudication.
Background and Rationale:
Metformin has demonstrable efficacy in slowing or reversing the progression of various
insulin-resistant disease states - most notably type 2 diabetes and pre-diabetes. In seeking
to establish proof-of-concept that insulin resistance is a suitable pathophysiological
target in the treatment of PAD-related intermittent claudication (pain in the leg muscles
during walking, which resolves on exercise cessation), this study will determine whether the
known insulin-sensitizing effects of metformin translate to alleviation of the functional
limitations imposed by claudication.
Study Design:
A total of 80 individuals with PAD-related intermittent claudication will be randomised
(1:1) to either metformin or matching placebo for 16-18 weeks (double-blind, parallel group
design). The maximum daily dose of metformin will be 2000mg (up-titrated from half this dose
at 2 weeks if tolerated).
Primary Hypothesis:
Improvement in functional capacity follows metformin therapy in individuals with PAD-related
intermittent claudication. Change in functional capacity will be assessed by the co-primary
endpoints of pain-free and maximum walking times during a standard graded treadmill exercise
test.
Secondary Aims:
Exercise testing for functional performance will be complemented by assessments of perceived
physical functioning / quality of life in the daily life setting (using standard
questionnaires). As previous studies have indicated cardiovascular effects of metformin
incremental to blood glucose-lowering, this study will also investigate potential mechanisms
of efficacy relating to the primary endpoints, including changes in endothelial function,
blood flow responses to various stimuli (including insulin and acute exercise), insulin
sensitivity, and physical activity / sedentary behaviours. Changes in relevant clinical data
(including ankle-brachial index and limb hemodynamics by duplex scanning) will also be
determined.
Outcomes and Significance:
The unmet clinical need of efficacious medical therapies for intermittent claudication is a
growing problem given the increasing prevalence of PAD worldwide. If positive, this study
will identify a new potential treatment that is already widely available. The study will
also inform on novel mechanistic targets with relevance to existing and future therapeutic
strategies.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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