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The investigators propose a pilot study to test the novel hypothesis that Exenatide treatment in patients with type 2 diabetes results in improved sleep duration and quality and to explore the relationship between improvements in sleep and measures of metabolic and circadian function. This project would be the first to probe the relationship between incretin hormone regulation, duration and intensity of sleep, glucose tolerance and circadian dysfunction in diabetic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual T2 DM med regimen | Placebo Comparator | Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks. |
|
| Usual T2 DM med regimen plus Exenatide | Experimental | Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide | Drug | Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-REM Slow Wave Sleep | Total minutes of non-REM sleep was measured | baseline and after 6 weeks of treatment |
| Total Amount of Slow Wave Activity | Total amount of slow wave activity during sleep derived from laboratory polysomnogram was measured | baseline and after 6 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency During Polysomnographic Recording | Sleep efficiency will be calculated as total sleep time over total recording time. | baseline and after 6 weeks of treatment |
| Minutes of Wake After Sleep Onset During Sleep Recording |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eve Van Cauter, PhD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States | ||
| University of Chicago |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual T2 DM Med Regimen | Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks. Placebo: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks |
| FG001 | Usual T2 DM Med Regimen Plus Exenatide | Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide. Exenatide: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual T2 DM Med Regimen | Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks. Placebo: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Non-REM Slow Wave Sleep | Total minutes of non-REM sleep was measured | The Electronic Sleep Recordings for one participant in Usual T2 DM med regimen were corrupted and could not be analyzed. One participant in Usual T2 DM med regimen plus Exenatide had a very short sleep periods during the study and his data could not be interpreted, therefore this patient was excluded from the analysis. | Posted | Mean | Standard Deviation | minutes | baseline and after 6 weeks of treatment |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual T2 DM Med Regimen | Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks. Placebo: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks |
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When the investigators were unblinded in August 2016, a randomization error originating from the industry sponsor was identified, where only 8 participants were randomized to exenatide while 10 were randomized to placebo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eve Van Cauter, PhD | The University of Chicago | 773-834-4001 | evcauter@bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| Placebo | Drug | Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks |
|
total amount of time spent awake after sleep onset and before morning awakening will be calculated
| baseline and after 6 weeks of treatment |
| Severity of Obstructive Sleep Apnea | The apnea-hypopnea index (AHI) will be calculated from polysomnographic recordings. The minimum score for AHI is 0 (zero), corresponding to total absence of apnea or hypopnea. There is no theoretical maximum score although scores above 100 are very rarely observed. The lower the AHI value, the better. Higher AHI values correspond to greater severity of sleep apnea, a worse outcome. There are no subscales. We use continuous AHI values to measure severity of obstructive sleep apnea. | baseline and after 6 weeks of treatment |
| Mean 24-h Blood Glucose Levels | Mean plasma levels of glucose will be calculated from samples collected across the 24-h cycle. | baseline and after 6 weeks of treatment |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Usual T2 DM Med Regimen Plus Exenatide |
Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide. Exenatide: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 |
| Usual T2 DM Med Regimen Plus Exenatide |
Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide. Exenatide: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks |
|
|
| Primary | Total Amount of Slow Wave Activity | Total amount of slow wave activity during sleep derived from laboratory polysomnogram was measured | The second primary outcome measure, slow-wave activity (SWA) was not collected. | Posted | baseline and after 6 weeks of treatment |
|
|
| Secondary | Sleep Efficiency During Polysomnographic Recording | Sleep efficiency will be calculated as total sleep time over total recording time. | The Electronic Sleep Recordings for one participant in Usual T2 DM med regimen were corrupted and could not be analyzed. One participant in Usual T2 DM med regimen plus Exenatide had a very short sleep periods during the study and his data could not be interpreted, therefore this patient was excluded from the analysis. | Posted | Mean | Standard Deviation | percentage of total recording time | baseline and after 6 weeks of treatment |
|
|
|
| Secondary | Minutes of Wake After Sleep Onset During Sleep Recording | total amount of time spent awake after sleep onset and before morning awakening will be calculated | The Electronic Sleep Recordings for one participant in Usual T2 DM med regimen were corrupted and could not be analyzed. One participant in Usual T2 DM med regimen plus Exenatide had a very short sleep periods during the study and his data could not be interpreted, therefore this patient was excluded from the analysis. | Posted | Mean | Standard Deviation | minutes | baseline and after 6 weeks of treatment |
|
|
|
| Secondary | Severity of Obstructive Sleep Apnea | The apnea-hypopnea index (AHI) will be calculated from polysomnographic recordings. The minimum score for AHI is 0 (zero), corresponding to total absence of apnea or hypopnea. There is no theoretical maximum score although scores above 100 are very rarely observed. The lower the AHI value, the better. Higher AHI values correspond to greater severity of sleep apnea, a worse outcome. There are no subscales. We use continuous AHI values to measure severity of obstructive sleep apnea. | The Electronic Sleep Recordings for one participant in Usual T2 DM med regimen were corrupted and could not be analyzed. One participant in Usual T2 DM med regimen plus Exenatide had a very short sleep periods during the study and his data could not be interpreted, therefore this patient was excluded from the analysis. | Posted | Mean | Standard Deviation | units on a scale | baseline and after 6 weeks of treatment |
|
|
|
| Secondary | Mean 24-h Blood Glucose Levels | Mean plasma levels of glucose will be calculated from samples collected across the 24-h cycle. | Posted | Mean | Standard Deviation | mg/dl | baseline and after 6 weeks of treatment |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Usual T2 DM Med Regimen Plus Exenatide | Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide. Exenatide: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks | 0 | 8 | 0 | 8 |
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| D004700 | Endocrine System Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |