Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance

Insomnia Clinical Trial

Official title:

Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156271
• Other study ID #: Pro00013501
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2014
• Last updated: July 9, 2015
• Start date: July 2007

Study information

• Verified date: May 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to help scientist better understand the effect of a 12-week single daily evening dose of ramelteon (Rozerem ©), a drug that has been approved by the U. S. Food and Drug Administration (FDA) for the treatment of insomnia (trouble falling asleep or staying asleep). The study will measure levels of inflammation, fasting insulin and fasting glucose (sugar) in subjects who are taking either ramelteon (8 mg) or placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

At screening visit:

• aged 18-65

• nonsmokers

• for women: oral contraceptive (OC) or hormone replacement therapy (HRT) nonusers

To schedule the baseline PSG (Visit 2), subjects must meet the following inclusion criteria:

• ages 18-65 inclusive;

• PSQI-Component 2 (sleep latency) score of greater than 1;

• non-smoker (e.g., less than 20 cigarettes in the past 5 years);

• habitual bedtime between 8:30 pm and midnight

• For premenopausal women:

• regular menstrual cycles determined by Framingham Study criteria;

• not pregnant and no history of oral contraceptive (OC) usage in last 6-months.

• For postmenopausal women:

• no recent (< 6 months) use of Hormone Replacement Therapy (HRT)

• no surgical menopause

Exclusion Criteria:

• positive urine drug screen

• Potential subjects with hypersensitivity to ramelteon or any components of the formulation will be excluded from participation.

• Given that ramelteon should not be used by individuals with severe hepatic impairment, or in patients in combination with fluvoxamine, individuals who report liver problem or use of fluvox will be excluded.

• use of rifampin (Rifadin ©); ketoconazole (Nizora ©l); or fluconazole (Diflucan ©).

• Ramelteon has not been studied in children or adolescents, and the effects in these populations are unknown, thus only individuals above 18 years will participate.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia
• Insulin Resistance

Intervention

Drug:
• ramelteon

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)	The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects. Sleep latency is defined as the length of time it takes from lying down for the night until sleep onset.	Day 89-90	No
Primary	Mean Latency to Persistent Sleep (LPS) Via Polysomnography	Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured.	Day 89-90	No
Primary	Change in Metabolic Syndrome (MetSyn)		Baseline, Day 30, Day 60, Day 89-90	No
Primary	Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)	Subjects completed component 2 of the PSQI questionnaire. Component 2 asks questions about sleep latency and is scored on a scale from 0 (better) to 3 (worse).	baseline	No
Primary	Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)	Subjects completed component 2 of the PSQI questionnaire. Component 2 asks questions about sleep latency and is scored on a scale from 0 (better) to 3 (worse).	day 89 - 90	No
Primary	Mean Latency to Persistent Sleep (LPS) Via Polysomnography	Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured.	Baseline	No
Primary	Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)	The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects.	Baseline	No
Secondary	Change in Total Sleep Time	Change in sleep time will be determined by PSG.	Day -1-0, Day 89-90	No
Secondary	Inflammatory Biomarkers C-reactive Protein (CRP)		Day 89-90	No
Secondary	Interleukin 6 (IL-6)		Day 89-90	No
Secondary	Insulin Resistance (IR)	In each subject, an insulin resistance score based on Homeostasis Model Assessment (HOMA-IR) was estimated at day 89-90. Formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).	Day 89-90	No
Secondary	Inflammatory Biomarkers C-reactive Protein (CRP)		Baseline	No
Secondary	Insulin Resistance (IR)	In each subject, an insulin resistance score based on Homeostasis Model Assessment (HOMA-IR) was estimated at baseline. Formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).	Baseline	No
Secondary	Interleukin 6 (IL-6)		Baseline	No