NCT00895570

The Effects of Modafinil to Counteract the Adverse Metabolic Consequences of Sleep Restriction

Sleep Restriction, Impaired Glucose Metabolism, and Performance: The Effects of Modafinil to Counteract the Adverse Metabolic Consequences of Sleep Restriction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Male
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to examine the effects of sleep and modafinil on how the body processes glucose.

Detailed description

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.

Conditions

• Sleep Restriction
• Impaired Glucose Metabolism

Interventions

Type	Name	Description
DRUG	modafinil	During each day of the 7-day sleep restriction phase of the study modafinil was administered (200 mg tablet at 0600, and a second dose of 100 mg tablet at 1300).
DRUG	placebo	During each day of the 7-day sleep restriction phase of the study a sugar pill was administered.

Timeline

• Start date: 2005-01-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2009-05-08
• Last updated: 2009-05-08

Locations

1 site across 1 country: United States