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

NCT00895570 | Completed

• 1 other identifier: C1538/6032/ES/US
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Restriction; Impaired Glucose Metabolism

Keywords

sleep restriction; glucose metabolism; modafinil; euglycemic clamp; insulin sensitivity; insulin release

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity measured with euglycemic hyperinsulinemic clamp

  Following 3 nights of a continued 'sleep replete' period with 10 hours/night of time in bed and again following 7 days sleep restricted to 5 hrs time in bed/night

Secondary Outcomes (8)

• Insulin release (i.e., pancreatic beta cell function) measured on IVGTT

  Following 3 nights of a continued 'sleep replete' period with 10 hours/night of time in bed and again following 7 days sleep restricted to 5 hrs time in bed/night

• Glucose effectiveness measured using an IVGTT, clamp

  Following 3 nights of a continued 'sleep replete' period with 10 hours/night of time in bed and again following 7 days sleep restricted to 5 hrs time in bed/night

• Biomarkers of Sleep Loss (HbA1c, fructosamine, insulin, glucose, cortisol thyrotropic axis function, lipid metabolism, leptin, ghrelin and cytokine signaling)

  Following 3 nights of a continued 'sleep replete' period with 10 hours/night of time in bed and again following 7 days sleep restricted to 5 hrs time in bed/night

• Subjective measures of sleepiness and alertness

  Every 3 hours while awake during the 12-day inpatient stay

• RMR assessed by indirect calorimetry

  On the morning and late afternoon of day 4 and 11

Study Arms (2)

Modafinil

EXPERIMENTAL

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: modafinil

Placebo

PLACEBO COMPARATOR

During each day of the 7-day sleep restriction phase of the study a sugar pill was administered.

Drug: placebo

Interventions

modafinil DRUG

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).

Also known as: Provigil

Modafinil

placebo DRUG

During each day of the 7-day sleep restriction phase of the study a sugar pill was administered.

Placebo

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must have also demonstrated a full understanding of the requirements and demands of the study.
• Individuals must have been willing to follow a regular sleep-wake schedule.

You may not qualify if:

• Sleep/wake history. During completion of the preliminary telephone and written screening questionnaires, potential volunteers were asked a number of questions about their present, past and desired habitual sleep/wake schedule, including their habitual and desired bedtimes, wake-times, and nap times. Those potential volunteers with a history of night-work in the preceding 3-year period or travel across \>2 time zones in the 3 months prior to the study were excluded.
• Individuals who are unable or unwilling to follow a regular sleep-wake schedule were excluded from the study.
• Drug/Alcohol Use. Volunteers must have been drug-free (including nicotine) and with moderate or no use of caffeine or alcohol for the entire duration of the study. No medications (prescription or over the counter) that significantly affect circadian rhythms, endocrine physiology, or sleep were allowed. They must have had no history of drug or alcohol dependency. No caffeine or alcohol were allowed for one week prior to or during the inpatient portion of the protocol. A comprehensive toxicological analysis of blood and urine for prescription medication, non-prescription medication, drugs of abuse, and caffeine, nicotine and alcohol metabolites was carried out for verification of reported non-use during the initial screening and on the day of admission to the laboratory for verification.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Buxton OM, Pavlova M, Reid EW, Wang W, Simonson DC, Adler GK. Sleep restriction for 1 week reduces insulin sensitivity in healthy men. Diabetes. 2010 Sep;59(9):2126-33. doi: 10.2337/db09-0699. Epub 2010 Jun 28.

  PMID: 20585000 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Orfeu M Buxton, Ph.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 8, 2009
• Study Start: January 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: May 8, 2009

Record last verified: 2009-05

Locations

US (1)