Sleep Restriction Clinical Trial
Official title:
Sleep Restriction, Impaired Glucose Metabolism, and Performance: The Effects of Modafinil to Counteract the Adverse Metabolic Consequences of Sleep Restriction
The purpose of the study is to examine the effects of sleep and modafinil on how the body processes glucose.
The occurrence and diagnosis of DM2 and its complications is increasing, leading to rising
treatment costs that represent a considerable portion of the U.S. health care budget.
Although treatment of impaired glucose tolerance (IGT) is not common, an IGT diagnosis
increases the likelihood of progression to DM2. Careful attention to glycemic control is a
primary treatment goal for DM2 patients, as glucose control reduces the severity of
microvascular, macrovascular, and other complications.
Recent research has indicated that sleep loss could be a previously unrecognized risk factor
for DM2. As sleep restriction has become an endemic condition in developed countries, it is
possible that sleep loss contributes to the recent epidemic of DM2. Protecting sleep by
increasing sleep duration and quality in DM2 and IGT patients may provide an inexpensive,
relatively easy to implement intervention to reduce the risk of disease onset or delay
disease progression by improving glucose tolerance. Furthermore, measurement of endocrine,
metabolic, and cardiovascular parameters in the proposed studies may provide insights into
the mechanisms by which sleep extension improves glucose tolerance under pathophysiological
conditions.
The proposed study examines and quantifies in adults the link between insufficient sleep and
increased insulin resistance, impaired insulin secretion, and reduced non-insulin-dependent
glucose utilization by the sleepy brain. The proposed study capitalizes upon the unique
pharmacological characteristics of modafinil to reverse excessive sleepiness to address the
mechanisms by which sleep restriction may impact metabolism via excessive sleepiness. This
study may lead to countermeasures to the adverse health impact of chronic insufficient
sleep, an increasingly common lifestyle that may ultimately contribute to the development of
the Metabolic Syndrome or DM2 via alterations of glucose metabolism and brain glucose
utilization.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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