Using Early Time Restricted Feeding and Timed Light Therapy to Improve Glycemic Control in Adults With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- 24-hour C-peptide levels
研究概览
简要总结
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.
详细描述
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:
- Determine whether early TRF and/or timed light therapy improve glycemic control
- (a) Determine how early TRF and/or timed light therapy affect the central and peripheral circadian clocks and (b) determine which patients benefit the most from circadian-based therapies
- Determine whether early TRF and/or timed light therapy improve sleep, body weight, body composition, cardiovascular risk factors, quality of life, and psychological health.
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:
- No change in eating or light exposure habits
- Early TRF
- Timed light therapy
- Early TRF and timed light therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The study statistician will be blinded. To the degree possible for each task, other study staff will be blinded during outcome assessments and analysis.
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 30-80 years old
- •Have type 2 diabetes
- •HbA1c between 5.7 - 12.0%
- •On a stable dose of metformin, DPP-IV inhibitors, SGLT2 inhibitors, sulfonylureas, and/or GLP-1 receptor agonists for at least 6 weeks, or taking no diabetes medications
- •Wake up at a regular time between 5-9 am
排除标准
- •On insulin or diabetes medication other than metformin, DPP-IV inhibitors, SGLT2 inhibitors, sulfonylureas, and/or GLP-1 receptor agonists
- •Have type 1 diabetes or was diagnosed with diabetes before age 18
- •Moderate or severe retinopathy or other medical condition that may affect the ability to safely receive bright light therapy
- •A history of severe hypoglycemia
- •Change in the dosage of a chronic medication within the past month (need to wait at least 1 month prior to baseline visit)
- •Have a clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
- •Severe gastrointestinal disease, major gastrointestinal surgery, or active gallstone disease
- •Cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that is unstable or may compromise study validity
- •Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years
- •Pregnant or breastfeeding
- •Current diagnosis of a major psychiatric condition that would impair study participation
- •Diagnosed sleep disorder or circadian disorder that is not stabilized (sleep apnea is allowed). Those with narcolepsy will not be included.
- •Major changes in health or medical history in the last 3 months that could affect data validity per judgement of the study physician
- •Spend an average of more than 1.5 hours/day outdoors
- •Perform overnight shift work more than 1 day/week on average
- •Regularly eat within a less than a 10-hour period daily
- •Regularly finish eating dinner before 6:30 pm
- •Lost or gained more than 8 lbs within the last 2 months and weight needs to be stable for a minimum of 4 weeks before baseline testing
- •Traveled more than two times zones away in the two months prior to enrolling in the trial or will travel more than two time zones away during the 16-week study
研究组 & 干预措施
Early Time-Restricted Feeding and Timed Light Therapy
干预措施: Early Time-Restricted Feeding (Behavioral)
Early Time-Restricted Feeding and Timed Light Therapy
干预措施: Timed Light Therapy (Behavioral)
No change in eating or light exposure habits
干预措施: No change in meal timing (Behavioral)
No change in eating or light exposure habits
干预措施: No change in light exposure (Behavioral)
Early Time-Restricted Feeding
干预措施: No change in light exposure (Behavioral)
Early Time-Restricted Feeding
干预措施: Early Time-Restricted Feeding (Behavioral)
Timed Light Therapy
干预措施: No change in meal timing (Behavioral)
Timed Light Therapy
干预措施: Timed Light Therapy (Behavioral)
结局指标
主要结局
24-hour C-peptide levels
时间窗: 16 weeks
Time-weighted mean, fasting, peak, standard deviation, and excursion values (pmol/l). This is also a proxy for total 24-hour insulin secretion.
Hemoglobin A1C
时间窗: 16 weeks
%
Insulin sensitivity
时间窗: 16 weeks
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.
Beta-cell responsivity index (a measure of beta-cell function)
时间窗: 16 weeks
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.
24-hour glucose levels
时间窗: 16 weeks
Time-weighted mean, fasting, peak, standard deviation, and excursion (maximum - minimum) values (mg/dl)
24-hour insulin levels
时间窗: 16 weeks
Time-weighted mean, fasting, peak, standard deviation, and excursion values (mU/l)
24-hour C-peptide levels
时间窗: 16 weeks
Time-weighted mean, fasting, peak, standard deviation, and excursion values (pmol/l). This is also a proxy for total 24-hour insulin secretion.
Hemoglobin A1C
时间窗: 16 weeks
%
Insulin sensitivity
时间窗: 16 weeks
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.
Beta-cell responsivity index (a measure of beta-cell function)
时间窗: 16 weeks
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.
Insulin secretion
时间窗: 16 weeks
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.
次要结局
- Cortisol Phase(16 weeks)
- Glycemic ("Peripheral") Rhythm Phase(16 weeks)
- Cortisol Amplitude(16 weeks)
- Glycemic ("Peripheral") Rhythm Amplitude(16 weeks)
- Melatonin Amplitude(16 weeks)
- Melatonin Phase(16 weeks)
研究者
Courtney M Peterson
Principal Investigator
University of Alabama at Birmingham