Time-Restricted Feeding + Light Therapy for Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Must be taking: Metformin, DPP-IV inhibitors
Must not be taking: Insulin
Disqualifiers: Type 1 diabetes, Severe retinopathy, Cancer, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be on a stable dose of certain diabetes medications like metformin, DPP-IV inhibitors, SGLT2 inhibitors, sulfonylureas, or GLP-1 receptor agonists for at least 6 weeks before joining. If you're on other diabetes medications, you may not be eligible.
What data supports the effectiveness of the treatment Time-Restricted Feeding + Light Therapy for Type 2 Diabetes?
Research shows that time-restricted feeding (TRF) can improve blood glucose control and insulin sensitivity in people with type 2 diabetes. Additionally, TRF has been positively perceived by participants and may help reduce the risk of chronic diseases by aligning eating patterns with natural circadian rhythms.
12345Is time-restricted feeding safe for humans?
Time-restricted feeding (TRE) has been studied in humans and is generally considered safe, with benefits like weight loss and improved blood sugar control. However, more research is needed to fully understand its long-term safety.
23678How is the treatment of Time-Restricted Feeding and Light Therapy unique for type 2 diabetes?
This treatment is unique because it combines time-restricted eating (a form of intermittent fasting) with light therapy to potentially improve blood sugar control and insulin sensitivity in people with type 2 diabetes. Unlike traditional treatments that often involve medication, this approach focuses on lifestyle changes to align eating patterns and light exposure with the body's natural circadian rhythms.
127910Eligibility Criteria
Adults aged 30-80 with type 2 diabetes, HbA1c levels between 7.0 - 10.0%, and waking up between 5-9 am can join this trial if they're on stable diabetes medication or none at all. Excluded are those with severe health issues like unstable heart or liver disease, major psychiatric conditions, outdoor activity over 1.5 hours/day, recent significant weight changes, or travel plans that disrupt time zones during the study.Inclusion Criteria
I am between 30 and 80 years old.
I have been on the same diabetes medication for at least 6 months or am not taking any.
Your HbA1c levels have been steady for the last 6 months (within 0.7%).
+2 more
Exclusion Criteria
I have type 1 diabetes or was diagnosed with diabetes before I turned 18.
I spend over 1.5 hours outside daily.
I haven't changed my chronic medication dose in the last 2 months.
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants follow their assigned treatment of either no change, early TRF, timed light therapy, or both for 16 weeks
16 weeks
Baseline and post-intervention testing during a 38-hour inpatient stay
Follow-up
Participants are monitored for safety and effectiveness after treatment
8 months
Participant Groups
The study is examining if eating earlier in the day combined with timed light therapy can better manage blood sugar in type 2 diabetics compared to no change in meal timing or light exposure. It will also assess effects on sleep, weight, body composition, cardiovascular health, quality of life and mood.
4Treatment groups
Experimental Treatment
Active Control
Group I: Timed Light TherapyExperimental Treatment2 Interventions
Group II: Early Time-Restricted Feeding and Timed Light TherapyExperimental Treatment2 Interventions
Group III: Early Time-Restricted FeedingExperimental Treatment2 Interventions
Group IV: No change in eating or light exposure habitsActive Control2 Interventions
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Alabama at Birmingham; Birmingham Veterans Affairs Medical CenterBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
References
Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes. [2023]To design an appealing time-restricted eating (TRE) intervention by exploring behavioral and social mechanisms to improve TRE adoption and maintenance among people with type 2 diabetes (T2D) and overweight. Time-restricted eating is an intermittent fasting regimen suggested to improve glycemic control and body weight.
Time-restricted feeding improves blood glucose and insulin sensitivity in overweight patients with type 2 diabetes: a randomised controlled trial. [2021]Time-restricted feeding is an emerging dietary intervention that is becoming increasingly popular. There are, however, no randomised clinical trials of time-restricted feeding in overweight patients with type 2 diabetes. Here, we explored the effects of time-restricted feeding on glycaemic regulation and weight changes in overweight patients with type 2 diabetes over 12 weeks.
Early time-restricted carbohydrate consumption vs conventional dieting in type 2 diabetes: a randomised controlled trial. [2023]Early time-restricted carbohydrate consumption (eTRC) is a novel dietary strategy that involves restricting carbohydrate-rich food intake to the morning and early afternoon to align with circadian variations in glucose tolerance. We examined the efficacy, feasibility and safety of eTRC in individuals with type 2 diabetes under free-living conditions.
A Delayed Morning and Earlier Evening Time-Restricted Feeding Protocol for Improving Glycemic Control and Dietary Adherence in Men with Overweight/Obesity: A Randomized Controlled Trial. [2020]We determined the effects of time-restricted feeding (TRF; 8 h/d) versus extended feeding (EXF; 15 h/d) on 24-h and postprandial metabolism and subjective opinions of TRF in men with overweight/obesity. In a randomized crossover design, 11 sedentary males (age 38 ± 5 y; BMI: 32.2 ± 2.0 kg/m2) completed two isoenergetic diet protocols for 5 days, consuming meals at 1000, 1300 and 1700 h (TRF) or 0700, 1400 and 2100 h (EXF). On Day 5, participants remained in the laboratory for 24 h, and blood samples were collected at hourly (0700-2300 h) then 2-hourly (2300-0700 h) intervals for concentrations of glucose, insulin and appetite/incretin hormones. Structured qualitative interviews were conducted following completion of both dietary conditions and investigated thematically. Total 24-h area under the curve (AUCtotal) [glucose] tended to be lower for TRF versus EXF (-5.5 ± 9.0 mmol/L/h, P = 0.09). Nocturnal glucose AUC was lower in TRF (-4.2 ± 5.8 mmol/L/h, P = 0.04), with no difference in waking glucose AUC or AUCtotal for [insulin]. Attitudes towards TRF were positive with improved feelings of well-being. Barriers to TRF were work schedules, family commitments and social events. Compared to extended feeding, short-term TRF improved nocturnal glycemic control and was positively perceived in men with overweight/obesity.
Time-restricted Eating for the Prevention and Management of Metabolic Diseases. [2022]Time-restricted feeding (TRF, animal-based studies) and time-restricted eating (TRE, humans) are an emerging behavioral intervention approach based on the understanding of the role of circadian rhythms in physiology and metabolism. In this approach, all calorie intake is restricted within a consistent interval of less than 12 hours without overtly attempting to reduce calories. This article will summarize the origin of TRF/TRE starting with concept of circadian rhythms and the role of chronic circadian rhythm disruption in increasing the risk for chronic metabolic diseases. Circadian rhythms are usually perceived as the sleep-wake cycle and dependent rhythms arising from the central nervous system. However, the recent discovery of circadian rhythms in peripheral organs and the plasticity of these rhythms in response to changes in nutrition availability raised the possibility that adopting a consistent daily short window of feeding can sustain robust circadian rhythm. Preclinical animal studies have demonstrated proof of concept and identified potential mechanisms driving TRF-related benefits. Pilot human intervention studies have reported promising results in reducing the risk for obesity, diabetes, and cardiovascular diseases. Epidemiological studies have indicated that maintaining a consistent long overnight fast, which is similar to TRE, can significantly reduce risks for chronic diseases. Despite these early successes, more clinical and mechanistic studies are needed to implement TRE alone or as adjuvant lifestyle intervention for the prevention and management of chronic metabolic diseases.
Randomized controlled trial for time-restricted eating in overweight and obese young adults. [2022]Time-restricted eating (TRE) is known to improve metabolic health, whereas very few studies have compared the effects of early and late TRE (eTRE and lTRE) on metabolic health. Overweight and obese young adults were randomized to 6-h eTRE (eating from 7 a.m. to 1 p.m.) (n = 21), 6-h lTRE (eating from 12 p.m. to 6 p.m.) (n = 20), or a control group (ad libitum intake in a day) (n = 19). After 8 weeks, 6-h eTRE and lTRE produced comparable body weight loss compared with controls. Compared with control, 6-h eTRE reduced systolic blood pressure, mean glucose, fasting insulin, insulin resistance, leptin, and thyroid axis activity, whereas lTRE only reduced leptin. These findings shed light on the promise of 6-h eTRE and lTRE for weight loss. Larger studies are needed to assess the promise of eTRE to yield better thyroid axis modulation and overall cardiometabolic health improvement.
Effect of Time-Restricted Eating on Weight Loss in Adults With Type 2 Diabetes: A Randomized Clinical Trial. [2023]Time-restricted eating (TRE) has become increasingly popular, yet longer-term randomized clinical trials have not evaluated its efficacy and safety in patients with type 2 diabetes (T2D).
Time-Restricted Eating: Benefits, Mechanisms, and Challenges in Translation. [2021]Eating out of phase with daily circadian rhythms induces metabolic desynchrony in peripheral metabolic organs and may increase chronic disease risk. Time-restricted eating (TRE) is a dietary approach that consolidates all calorie intake to 6- to 10-h periods during the active phase of the day, without necessarily altering diet quality and quantity. TRE reduces body weight, improves glucose tolerance, protects from hepatosteatosis, increases metabolic flexibility, reduces atherogenic lipids and blood pressure, and improves gut function and cardiometabolic health in preclinical studies. This review discusses the importance of meal timing on the circadian system, the metabolic health benefits of TRE in preclinical models and humans, the possible mechanisms of action, the challenges we face in implementing TRE in humans, and the possible consequences of delaying initiation of TRE.
Time-restricted eating improves measures of daily glycaemic control in people with type 2 diabetes. [2023]Examine the effect of 5 d/wk, 9-h time-restricted eating (TRE) protocol on 24-h glycaemic control in adults with type 2 diabetes (T2D).
Time-restricted eating did not alter insulin sensitivity or β-cell function in adults with obesity: A randomized pilot study. [2023]Decreased insulin sensitivity and impairment of β-cell function predate and predict development of type 2 diabetes mellitus. Time-restricted eating (TRE) might have a benefit for these parameters. The objective of this pilot study was to investigate this possibility.