Trial Outcomes & Findings for Sleep Loss and Mechanisms of Impaired Glucose Metabolism (NCT NCT00555750)
NCT ID: NCT00555750
Last Updated: 2013-12-10
Results Overview
Difference in glucose tolerance (Kg) in response to insulin-modified intravenous glucose tolerance test. Glucose tolerance was calculated as the slope of the natural log of declining glucose values from minute 5 to minute 19 post-infusion. By convention, this negative slope is multiplied by -1, in other words, expressed as a rate of disposal.
COMPLETED
NA
20 participants
baseline and 2 months post-treatment
2013-12-10
Participant Flow
Participant milestones
| Measure |
Eszopiclone
nightly active medication (eszopiclone, 3 mg tablet) oral administration \~30 min before bed
|
Placebo
nightly placebo (identical tablet to active medication) oral administration \~30 min before bed
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sleep Loss and Mechanisms of Impaired Glucose Metabolism
Baseline characteristics by cohort
| Measure |
Active
n=10 Participants
active medication administration nightly before bed
|
Placebo
n=10 Participants
nightly administration of placebo before bed
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 2 months post-treatmentDifference in glucose tolerance (Kg) in response to insulin-modified intravenous glucose tolerance test. Glucose tolerance was calculated as the slope of the natural log of declining glucose values from minute 5 to minute 19 post-infusion. By convention, this negative slope is multiplied by -1, in other words, expressed as a rate of disposal.
Outcome measures
| Measure |
Active
n=10 Participants
active medication administration nightly before bed
|
Placebo
n=10 Participants
nightly administration of placebo before bed
|
|---|---|---|
|
Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test
|
.33 %/min, slope of natural log glucose
Standard Deviation .94
|
-0.10 %/min, slope of natural log glucose
Standard Deviation .42
|
SECONDARY outcome
Timeframe: baseline and 2 months post-treatmentChange over two months in 1st phase Insulin secretion
Outcome measures
| Measure |
Active
n=10 Participants
active medication administration nightly before bed
|
Placebo
n=10 Participants
nightly administration of placebo before bed
|
|---|---|---|
|
Acute Insulin Response to Glucose (AIRg)
|
94.0 mU*l^-1*min
Standard Deviation 269.0
|
25.1 mU*l^-1*min
Standard Deviation 74.7
|
SECONDARY outcome
Timeframe: baseline and 2 months post-treatmentInsulin sensitivity index (SI) "was defined in quantitative terms as the effect of insulin to catalyse the disappearance of glucose from plasma." \[R. Bergman, Horm Res 2005;64(suppl 3):8-15\]. SI calculated using Bergman's Minimal model analyses (Minmod Millennium 2000; R. Bergman, University of South- ern California, Los Angeles, CA)
Outcome measures
| Measure |
Active
n=10 Participants
active medication administration nightly before bed
|
Placebo
n=10 Participants
nightly administration of placebo before bed
|
|---|---|---|
|
Change in Insulin Sensitivity (SI)
|
-1.19 mU/l)^-1*min^-1
Standard Deviation 2.57
|
0.05 mU/l)^-1*min^-1
Standard Deviation 3.43
|
SECONDARY outcome
Timeframe: baseline and 2 months post-treatmentGlucose effectiveness was defined as "the ability of glucose itself to enhance its own disappearance independent of an increment in insulin." \[R. Bergman, Horm Res 2005;64(suppl 3):8-15\]. SG calculated using Bergman's Minimal model analyses (Minmod Millennium 2000; R. Bergman, University of South- ern California, Los Angeles, CA)
Outcome measures
| Measure |
Active
n=10 Participants
active medication administration nightly before bed
|
Placebo
n=10 Participants
nightly administration of placebo before bed
|
|---|---|---|
|
Change in Glucose Effectiveness (SG)
|
0.001 min^-1
Standard Deviation 0.004
|
0.001 min^-1
Standard Deviation 0.009
|
SECONDARY outcome
Timeframe: baseline and 2 months post-treatmentDifference in HbA1c levels following two months treatment with eszopiclone versus placebo
Outcome measures
| Measure |
Active
n=10 Participants
active medication administration nightly before bed
|
Placebo
n=10 Participants
nightly administration of placebo before bed
|
|---|---|---|
|
Change in HbA1c Levels
|
.03 percentage of glycosylation
Standard Error .11
|
-.09 percentage of glycosylation
Standard Error .06
|
SECONDARY outcome
Timeframe: baselineLeptin Levels prior to two months treatment with eszopiclone or placebo, measure after an overnight fast
Outcome measures
| Measure |
Active
n=10 Participants
active medication administration nightly before bed
|
Placebo
n=10 Participants
nightly administration of placebo before bed
|
|---|---|---|
|
Pre-Treatment Leptin Levels
|
4.99 ng/mL
Standard Deviation 3.63
|
16.53 ng/mL
Standard Deviation 11.37
|
SECONDARY outcome
Timeframe: two months post-treatmentLeptin levels following two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast
Outcome measures
| Measure |
Active
n=9 Participants
active medication administration nightly before bed
|
Placebo
n=10 Participants
nightly administration of placebo before bed
|
|---|---|---|
|
Post-treatment Leptin Levels
|
5.49 ng/mL
Standard Deviation 4.33
|
15.28 ng/mL
Standard Deviation 9.94
|
SECONDARY outcome
Timeframe: baselineGhrelin levels prior to two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast
Outcome measures
| Measure |
Active
n=10 Participants
active medication administration nightly before bed
|
Placebo
n=10 Participants
nightly administration of placebo before bed
|
|---|---|---|
|
Pre-treatment Ghrelin Levels
|
573.14 ng/mL
Standard Deviation 336.50
|
648.41 ng/mL
Standard Deviation 230.95
|
SECONDARY outcome
Timeframe: 2 months post-treatmentGhrelin levels following two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast
Outcome measures
| Measure |
Active
n=9 Participants
active medication administration nightly before bed
|
Placebo
n=10 Participants
nightly administration of placebo before bed
|
|---|---|---|
|
Post-treatment Ghrelin Levels
|
544.95 ng/mL
Standard Deviation 273.65
|
670.94 ng/mL
Standard Deviation 180.36
|
SECONDARY outcome
Timeframe: baseline and 2 months post-treatmentAt visits before and after two months treatment with 3mg eszopiclone or placebo, subjects completed a short test battery including the Karolinska Sleepiness Scale (KSS) every three hours during wake periods. KSS is a single-item scale of sleepiness on a scale from 1 ("very alert") to 9 ("very sleepy, fighting sleep, an effort to keep awake"). Subjective sleepiness was defined as mean deviation from baseline KSS.
Outcome measures
| Measure |
Active
n=10 Participants
active medication administration nightly before bed
|
Placebo
n=10 Participants
nightly administration of placebo before bed
|
|---|---|---|
|
Change in Subjective Sleepiness as Measured on the Karolinska Sleepiness Scale (KSS)
|
0.53 units on a scale
Standard Error 0.42
|
0.38 units on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: baseline and 2 months post-treatmentAt visits before and after two months treatment with 3mg eszopiclone or placebo, subjects completed a short test battery every three hours during wake periods. The battery included the Psychomotor Vigilance Task (PVT). The PVT involved a 10-minute visual reaction time (RT) performance test in which the subject was instructed to maintain the fastest possible RT to a simple visual stimulus. Lapses of attention refer to the number of times the subject failed to respond to the signal within 500ms. Mean lapses per test across 6 tests given a 4 hour intervals during normal waking hours (and not during the IVGTT) during the 30-hr were compared for the post-treatment visit as the absolute deviation from the baseline mean lapses/test.
Outcome measures
| Measure |
Active
n=10 Participants
active medication administration nightly before bed
|
Placebo
n=10 Participants
nightly administration of placebo before bed
|
|---|---|---|
|
Change in Mean Lapses of Attention
|
-0.04 lapses of attention
Standard Error 0.49
|
0.07 lapses of attention
Standard Error 0.29
|
SECONDARY outcome
Timeframe: baseline and 2 months post-treatmentTotal sleep time reported on sleep diaries prior to treatment with 3mg eszopiclone or placebo. Change defined as baseline minus post-treatment).
Outcome measures
| Measure |
Active
n=9 Participants
active medication administration nightly before bed
|
Placebo
n=10 Participants
nightly administration of placebo before bed
|
|---|---|---|
|
Change in Total Sleep Time as Reported in Sleep Diaries
|
.58 hours
Standard Deviation .36
|
.09 hours
Standard Deviation .01
|
SECONDARY outcome
Timeframe: baseline and 2 months post-treatmentChange (baseline minus post-treatment) in total sleep time measured by polysomnography after two months treatment with 3mg eszopiclone or placebo
Outcome measures
| Measure |
Active
n=10 Participants
active medication administration nightly before bed
|
Placebo
n=10 Participants
nightly administration of placebo before bed
|
|---|---|---|
|
Change in Total Sleep Time Measured by PSG
|
2.9 minutes
Standard Deviation 25.5
|
-6.4 minutes
Standard Deviation 30.2
|
Adverse Events
Active
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active
n=10 participants at risk
active medication administration nightly before bed
|
Placebo
n=10 participants at risk
nightly administration of placebo before bed
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
10.0%
1/10 • Number of events 3
|
20.0%
2/10 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Unpleasant Taste
|
40.0%
4/10 • Number of events 5
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Burning at infusion site
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Burning sensation
|
10.0%
1/10 • Number of events 3
|
0.00%
0/10
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10
|
20.0%
2/10 • Number of events 3
|
|
Cardiac disorders
Dizziness
|
30.0%
3/10 • Number of events 3
|
20.0%
2/10 • Number of events 3
|
|
Gastrointestinal disorders
Dry Mouth
|
20.0%
2/10 • Number of events 2
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1
|
30.0%
3/10 • Number of events 4
|
|
Eye disorders
Eye irritation
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Feeling Hot
|
40.0%
4/10 • Number of events 5
|
60.0%
6/10 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
20.0%
2/10 • Number of events 2
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Headache
|
20.0%
2/10 • Number of events 3
|
50.0%
5/10 • Number of events 6
|
|
Injury, poisoning and procedural complications
Injection pressure sensation
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Reproductive system and breast disorders
Menstruation with increased bleeding
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
2/10 • Number of events 2
|
20.0%
2/10 • Number of events 2
|
|
Nervous system disorders
Paraesthesia
|
10.0%
1/10 • Number of events 1
|
30.0%
3/10 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Puncture Site Pain
|
20.0%
2/10 • Number of events 2
|
30.0%
3/10 • Number of events 3
|
|
Psychiatric disorders
Somnolence
|
20.0%
2/10 • Number of events 2
|
20.0%
2/10 • Number of events 3
|
|
Injury, poisoning and procedural complications
Vasovagal reaction
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vasovagal syncope
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Venipuncture site bruising
|
10.0%
1/10 • Number of events 1
|
30.0%
3/10 • Number of events 4
|
Additional Information
Dr. John Winkelman, MD, PhD
Brigham and Women's Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place