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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-19-1-0558 | Other Grant/Funding Number | Department of Defense |
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The purpose of this study is to test whether eating earlier in the day and/or timed light therapy can improve blood sugar in people with type 2 diabetes. This study will also test whether these treatments improve other aspects of health, including the circadian (biological) clock, sleep, weight, body composition, cardiovascular health, quality of life, and mood.
The circadian system is strongly linked to type 2 diabetes. Adults with type 2 diabetes have circadian rhythms that are both weakened and mistimed. Weak rhythms may be due to insufficient bright light exposure during the daytime, irregular meal timing, or grazing on food throughout the day. Mistiming may be due to ill-timed food intake or light exposure-such as eating later in the day or light exposure at night-which causes central and peripheral circadian clocks within the body to become out of sync (circadian misalignment). This circadian misalignment impairs glucose metabolism: data now show that eating late in the day and light exposure at night rapidly elevate glucose (blood sugar) and insulin levels in humans within days. Conversely, well-timed food intake and light exposure appear to improve glycemic (blood sugar) control, circadian rhythms, and several other aspects of health.
This study will test the health effects of eating early in the daytime (early time-restricted feeding; early TRF) and timed light therapy in adults with type 2 diabetes. The study will test the following aims:
Approximately 344 veterans and civilians aged 30-80 with insulin-independent type 2 diabetes will be randomized to the following 2 x 2 study design:
Participants will be asked to follow their assigned treatment for 16 weeks and then be followed up for an additional eight months (1 year in total). Baseline and post-intervention testing will be conducted during a 38-hour inpatient (hospital) stay. Testing will involve three 3-hour meal tolerance tests to determine insulin sensitivity and secretion; 24-hour measurement of glucose, insulin, and C-peptide levels; 24-hour measurement of cortisol and melatonin to measure the phase and amplitude of the central clock; and a constant glucose infusion to determine the phase and amplitude of the effective glycemic ("peripheral") circadian clock. Sleep, weight loss, body composition, and cardiovascular risk factors will also be measured, and questionnaires and an interview will be administered to determine improvements in quality of life and psychological health.
Note: Pre-registered primary and secondary outcomes are listed below. Pre-registered tertiary outcomes appear in the study protocol, which will be uploaded to this website.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No change in eating or light exposure habits | Active Comparator |
| |
| Early Time-Restricted Feeding | Experimental |
| |
| Timed Light Therapy | Experimental |
| |
| Early Time-Restricted Feeding and Timed Light Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No change in meal timing | Behavioral | Participants will eat within an ≥11-hour daily period (no change in meal timing habits). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour glucose levels | Time-weighted mean, fasting, peak, standard deviation, and excursion (maximum - minimum) values (mg/dl) | 16 weeks |
| 24-hour insulin levels | Time-weighted mean, fasting, peak, standard deviation, and excursion values (mU/l) | 16 weeks |
| 24-hour C-peptide levels | Time-weighted mean, fasting, peak, standard deviation, and excursion values (pmol/l). This is also a proxy for total 24-hour insulin secretion. | 16 weeks |
| Hemoglobin A1C | % | 16 weeks |
| Insulin sensitivity | Insulin sensitivity (dl/kg/min/μU/ml) during three identical meal tolerance tests, as measured by the Oral Minimal Model. The individual, mean, and excursion values, and time of the peak value will also be calculated. | 16 weeks |
| Beta-cell responsivity index (a measure of beta-cell function) | Beta-cell responsivity during three identical meal tolerance tests, as measured by the Oral Minimal Model. The individual, mean, and excursion values, and time of the peak value will also be calculated. | 16 weeks |
| Insulin secretion | Insulin secretion (mU) across three identical meal tolerance tests, as measured by the Oral Minimal Model. The individual, mean, and excursion values, and time of the peak value will also be calculated. |
| Measure | Description | Time Frame |
|---|---|---|
| Melatonin Amplitude | Peak value (pg/mL) | 16 weeks |
| Cortisol Amplitude | Amplitude (μg/dl) | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Courtney Peterson, Ph.D. | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham; Birmingham Veterans Affairs Medical Center | Birmingham | Alabama | 35294 | United States |
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The study statistician will be blinded. To the degree possible for each task, other study staff will be blinded during outcome assessments and analysis.
| No change in light exposure | Behavioral | Participants will not change their light exposure habits. |
|
| Early Time-Restricted Feeding | Behavioral | Participants will eat within an 8-hour daily period early in the day, starting within 2 hours of waking up. |
|
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| Timed Light Therapy | Behavioral | Participants will use bright light therapy for 60 minutes between 6 am - 3 pm, blue light-blocking glasses for one hour before bedtime, and blackout curtains at night. |
|
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| 16 weeks |
| Melatonin Phase | Clock time of dim light melatonin onset (DLMO) | 16 weeks |
| Cortisol Phase | Clock time of cortisol phase | 16 weeks |
| Glycemic ("Peripheral") Rhythm Amplitude | Amplitude or diurnal variation in glucose levels (mg/dl) during a constant glucose infusion procedure | 16 weeks |
| Glycemic ("Peripheral") Rhythm Phase | Time of day that glucose levels experience a nadir during a constant glucose infusion procedure | 16 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D014467 | Ultraviolet Therapy |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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