Circadian Rhythm Optimization for High Blood Sugar

(CHRONO Trial)

Overseen By Emily Manoogian, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Salk Institute for Biological Studies

Must be taking: Cardiovascular medications

Must not be taking: Sulfonylurea, Insulin

Disqualifiers: Type 1 diabetes, Insulin-dependent diabetes, Uncontrolled psychiatric disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a personalized lifestyle plan can improve blood sugar levels, as well as physical, cognitive, and immune functions. Participants will receive a tailored plan focusing on diet, exercise, and sleep, aligned with their body's natural rhythms (circadian rhythm optimization). It targets older adults with high blood sugar and a long daily eating window. Ideal candidates have elevated blood sugar levels, eat over a 12-hour period daily, and can attend exercise sessions. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to personalized health improvements.

Will I have to stop taking my current medications?

You can continue taking your current medications if they are for cardiovascular issues and you have been on a stable dose for 6 months. However, you cannot change the dose during the study.

What prior data suggests that this lifestyle plan is safe for older adults with high blood sugar?

Research shows that aligning with your body's natural daily rhythms can boost health. This approach, called Circadian Rhythm Optimization, involves timing meals, sleep, and exercise to match your body's natural schedule. Studies have found that disrupting these rhythms can lead to issues like high blood sugar and other health problems.

While specific studies on the safety of this exact program are lacking, adjusting your daily routine to align with your body's natural clock is generally safe. As a non-invasive method, it avoids medical procedures or drugs, offering a low-risk option for managing blood sugar levels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Circadian Rhythm Optimization for managing high blood sugar because it offers a novel approach by aligning a person’s daily activities with their natural internal clock. Unlike traditional treatments that often focus on medication or diet adjustments, this method emphasizes behavioral changes to optimize the body’s natural rhythms. By tailoring lifestyle habits to the body's biological clock, this technique could potentially improve blood sugar control with fewer side effects and a more personalized approach.

What evidence suggests that circadian rhythm optimization is effective for high blood sugar?

Research has shown that aligning daily activities with the body's natural schedule can help control blood sugar. Studies have found that exercising at times that align with the body's internal clock can significantly improve blood sugar management. This internal clock, known as the circadian system, plays a crucial role in sugar regulation. When this system is out of sync, it can lead to poor sugar management and high blood sugar. Planning meals, exercise, and sleep around these natural rhythms may enhance physical and mental health. This method is particularly beneficial for individuals with type 2 diabetes. Participants in this trial will receive a personalized plan focused on synchronizing their behavior with their endogenous rhythm to optimize blood sugar management. ^{6 7 8 9 10}

Who Is on the Research Team?

Satchidananda Panda, PhD

Principal Investigator

Salk Institute for Biological Studies

Pam Taub, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for older adults who usually eat over a span of 12 hours or more and have high blood sugar levels. It's designed to help with blood sugar control, diabetes, circadian rhythm disorders, aging, and sleep issues by optimizing daily routines.

Inclusion Criteria

I am between 50 and 80 years old.

Fasting glucose ≥ 100 mg/dL or HbA1c > 5.6%

Own a smartphone (Apple iOS or Android OS)

Exclusion Criteria

Uncontrolled psychiatric disorder including prior hospitalization

HbA1C > 9.0%

I have not used sulfonylurea or insulin in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline Assessment

Baseline assessments to develop personalized circadian rhythm optimization plan

2 weeks

Guided Intervention

Participants follow a personalized circadian rhythm optimization plan including diet, exercise, and sleep modifications

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Circadian Rhythm Optimization

Trial Overview Participants will follow a personalized lifestyle plan aimed at enhancing their biological rhythms. This includes tailored advice on diet, exercise, and sleep habits. The impact on blood sugar levels and overall health will be monitored over two months.

How Is the Trial Designed?

Group I: Circadian Rhythm Optimization Experimental Treatment 1 Intervention

Each participant will be provided with a personalized plan centered on synchronizing their behavior with their endogenous rhythm.

Who Is Running the Clinical Trial?

Salk Institute for Biological Studies

Lead Sponsor

Trials

23

Recruited

2,200+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7002226/

Impact of circadian disruption on glucose metabolism In this review, we cover the role of the circadian system and its disruption in glucose metabolism in healthy individuals and individuals with type 2 diabetes ...

2. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2023.1156757/full

The circadian rhythm: an influential soundtrack in ... The aim of this study is to explore the importance of the circadian rhythm in the occurrence of T2DM via reviewing the metabolic pathways involved.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0939475322001880

Effect of exercises according to the circadian rhythm in type ... A cross-controlled study by Menek and Budak [44] shows that training in keeping with the circadian rhythm leads to the greatest improvements in glycemic control ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5995632/

Circadian Regulation of Glucose, Lipid, and Energy ... Studies in humans report circadian rhythms in glucose, insulin, glucose tolerance, lipid levels, energy expenditure, and appetite.

5. nature.com nature.com/articles/s41387-020-0109-6

Chrononutrition in the management of diabetes In some acute trials, both healthy individuals and type 2 diabetics showed significantly higher blood glucose and insulin values after night- ...

6. e-dmj.org e-dmj.org/journal/view.php?number=2879

Artificial Light at Night and Type 2 Diabetes Mellitus Melatonin rhythmicity is considered an indicator of the central circadian rhythms [51], including sleep-wake cycles and metabolism [52].

7. drc.bmj.com drc.bmj.com/content/10/2/e002632

Rest-activity circadian rhythm and impaired glucose ... Circadian disruption is significantly associated with impaired glucose homeostasis in a general population of adults without diabetes.

8. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001388

Role of Circadian Health in Cardiometabolic Health and ... Overall, disruption of the circadian rhythm of BP is associated with elevated BP, hypertension, and CVD risk, but additional research is ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10333930/

The circadian rhythm: an influential soundtrack in the diabetes ... The aim of this study is to explore the importance of the circadian rhythm in the occurrence of T2DM via reviewing the metabolic pathways involved.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT07203196

Circadian Health Regulation and Optimization for ... The purpose of this study is to assess if modifying lifestyle behaviors such as improving nutrition quality while consolidating caloric intake ...