Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Bedtimes and wake-up times vary from person to person. The aim of this research is to examine the associations between sleep habits and metabolism in healthy people. In this study, the investigators will collect information on sleep-wake habits and how the body uses energy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Arm 1 | Active Comparator | Sleep Arm 1 |
|
| Sleep Arm 2 | Active Comparator | Sleep Arm 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sleep | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in insulin sensitivity (SI) | Insulin sensitivity will be derived from minimal model analysis of mixed meal tolerance test. The mixed meal tolerance test is performed at the end of the first 2-week period and at the end of the second 2-week period. For each subject, the change from the first 2-week period in insulin sensitivity will be calculated. | The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. |
| Change from Baseline in total energy expenditure | Total energy expenditure will be derived from doubly labeled water method. For each subject, total energy expenditure will be calculated during each 2-week period and then the change from the first 2-week period in total energy expenditure will be calculated. | The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. |
| Change from Baseline in energy intake | Energy intake will be derived from doubly labeled water method and body composition analysis. For each subject, energy intake will be calculated during each 2-week period and then the change from the first 2-week period in energy intake will be calculated. | The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. |
| Change from Baseline in beta-cell function | Beta cell function will be derived from minimal model analysis of mixed meal tolerance test. The mixed meal tolerance test is performed at the end of the first 2-week period and at the end of the second 2-week period. For each subject, the change from the first 2-week period in beta-cell function will be calculated. | The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. |
| Change from Baseline in disposition index |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in body weight | Weight will be derived from scale weight measurements. For each subject, their change in weight will be calculated during each period and then the change from the first 2-week period in body weight will be calculated. | The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Esra Tasali, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35129580 | Derived | Tasali E, Wroblewski K, Kahn E, Kilkus J, Schoeller DA. Effect of Sleep Extension on Objectively Assessed Energy Intake Among Adults With Overweight in Real-life Settings: A Randomized Clinical Trial. JAMA Intern Med. 2022 Apr 1;182(4):365-374. doi: 10.1001/jamainternmed.2021.8098. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 3, 2022 | |
| Reset | May 19, 2022 | |
| Release | Jun 3, 2022 | |
| Reset | Mar 14, 2023 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 18, 2019 | Jan 8, 2020 | ICF_000.pdf |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 3, 2022 | May 19, 2022 | |||
| Jun 3, 2022 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
| ID | Term |
|---|---|
| D012890 | Sleep |
| ID | Term |
|---|---|
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Disposition index will be derived from minimal model analysis of mixed meal tolerance test. The mixed meal tolerance test is performed at the end of the first 2-week period and at the end of the second 2-week period. For each subject, the change from the first 2-week period in disposition index will be calculated. |
| The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. |
| Mar 14, 2023 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |