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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Hypothesis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Sleepers | Active Comparator | Prediabetes patients with normal sleep duration (7-8 hours/ night) as measured objectively |
|
| Short Sleepers | Experimental | Prediabetes patients with short sleep duration (<6 hours/night) as measured objectively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral glucose tolerance | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| GLP-1 Levels in Response to Oral Glucose Tolerance Test | Prediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Ramathibodi Hospital | Bangkok | Thailand |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Sleepers | Prediabetes patients with normal sleep duration (>=6.5 hours/ night) as measured objectively Oral glucose tolerance |
| FG001 | Short Sleepers | Prediabetes patients with short sleep duration (=<5.75 hours/night) as measured objectively Oral glucose tolerance |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Sleeper | Sleep duration as measured by actigraphy >=6.5 h/night |
| BG001 | Short Sleeper | Sleep duration as measured by actigraphy =<5.75 h/night |
| 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 | GLP-1 Levels in Response to Oral Glucose Tolerance Test | Prediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels | Posted | Median | Inter-Quartile Range | pmol/l.h | 2 weeks |
|
|
18 month
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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 | Normal Sleeper | Sleep duration as measured by actigraphy >=6.5 h/night | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sirimon Reutrakul | Ramathibodii Hospital, Mahidol University | 66922011647 | 708 | sreutrakul@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2014 | Sep 11, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Participants |
|
|
|
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Short Sleeper | Sleep duration as measured by actigraphy =<5.7 h/night | 0 | 27 | 0 | 27 | 0 | 27 |
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| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |