34 Participants Needed

Lifestyle Changes for Prediabetes

LB
MS
LN
Overseen ByLena Navarro
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how stable lifestyle habits can help people with prediabetes manage blood sugar and improve overall health. Participants will either maintain their usual routines or follow a set schedule for eating and sleeping over 12 weeks. The goal is to determine if a regular routine can improve health outcomes. This trial may suit those with prediabetes who sleep at least six hours a night and have irregular bedtimes. As an unphased trial, it offers a unique opportunity to contribute to understanding lifestyle impacts on prediabetes management.

Will I have to stop taking my current medications?

The trial excludes participants who are on medications that affect insulin sensitivity, glucose concentrations, and body weight, so you may need to stop taking such medications to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that lifestyle changes are generally safe and can greatly benefit people with prediabetes. Studies have found that improving diet and increasing exercise can reduce the risk of developing type 2 diabetes by 58%. These changes are not only safe but also effective in managing blood sugar levels.

Other research found that lifestyle changes were 44% more effective than standard care in helping people return to normal blood sugar levels, suggesting that most people can handle these changes well. Additionally, losing just 5% of body weight can lead to better health, achievable through these lifestyle changes.

Overall, changes like maintaining a regular eating and sleeping schedule are safe and can improve health without major risks.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of lifestyle changes on prediabetes, focusing on stabilizing daily routines through a Fixed Schedule. Unlike current treatment options that often rely on medication or dietary changes, this approach emphasizes consistency in lifestyle behaviors like sleep and activity patterns. By potentially reducing blood sugar levels through structured daily habits, this method could offer a non-pharmacological, accessible way to manage prediabetes. The trial aims to find out if maintaining a fixed schedule can significantly improve health outcomes for people at risk of developing type 2 diabetes.

What evidence suggests that this trial's treatments could be effective for prediabetes?

Research has shown that lifestyle changes can significantly lower the risk of developing type 2 diabetes. This trial will compare two approaches: participants in the Fixed Schedule arm will stabilize their lifestyle behaviors for 12 weeks, while those in the Variable Schedule arm will maintain their usual habits. Studies have found that focusing on physical activity, healthy eating, and weight loss can reduce the risk by 58%. Specifically, another study discovered that these lifestyle changes were 44% more effective than standard care in normalizing blood sugar levels. Additionally, these changes can help control blood sugar and improve overall health in people at high risk. This evidence supports the idea that maintaining healthy habits can effectively manage prediabetes.12678

Who Is on the Research Team?

MS

Marie-Pierre St-Onge

Principal Investigator

Columbia University

BL

Blandine Laferrere

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for adults aged 35 or older with prediabetes, defined by specific blood sugar levels (hemoglobin A1c between 5.7-6.4%). Participants should have a BMI of 25-39.9 and sleep at least 6 hours nightly. Excluded are those with cardiovascular disease, certain kidney conditions, sleep apnea, recent weight loss programs, severe lipid problems, shift workers, substance abuse history, uncontrolled high blood pressure or psychiatric disorders.

Inclusion Criteria

Your body mass index (BMI) is between 25 and 39.9.
You sleep for at least 6 hours every night, as measured by a special wrist device for 14 nights.
My A1c levels are between 5.7% and 6.4%, indicating pre-diabetes.
See 2 more

Exclusion Criteria

I have been diagnosed with obstructive sleep apnea.
I have a psychiatric or neurological condition.
I can travel across different time zones.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Baseline Assessment

Participants track their sleep and wear a glucose monitor to measure glucose levels

2 weeks
1 visit (in-person)

Treatment

Participants are randomized to either maintain usual habits or stabilize lifestyle behaviors

12 weeks
2 visits (in-person) at start and end

Follow-up

Participants are monitored for changes in glucose control, body composition, and liver fat

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Fixed Schedule
  • Fixed Sleep
Trial Overview The study tests whether having a fixed schedule for daily activities can improve blood sugar control and body composition in people with prediabetes. It aims to see if stable lifestyle patterns reduce liver fat and help manage glucose levels better than variable lifestyles.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Fixed ScheduleExperimental Treatment1 Intervention
Group II: Variable ScheduleActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Department of Health and Human Services

Collaborator

Trials
240
Recruited
944,000+

Published Research Related to This Trial

Collaboration between sleep/circadian researchers and metabolism/diabetes experts is essential to translate basic research findings into practical strategies for improving metabolic health, particularly in the context of sleep disruption.
There is a significant opportunity to explore the effects of CPAP treatment for obstructive sleep apnea on pre-diabetes and the impact of temporal restricted feeding on obesity, which could lead to new preventative measures against diabetes.
Impact of Sleep and Circadian Disruption on Energy Balance and Diabetes: A Summary of Workshop Discussions.Arble, DM., Bass, J., Behn, CD., et al.[2022]
In a study of 1,510 participants with prediabetes, those with both impaired fasting glucose and impaired glucose tolerance (IFG+IGT) experienced greater sustained weight loss (3.5%) after a 3-year lifestyle intervention compared to those with isolated impaired fasting glucose (iIFG), who lost 2.5%.
Participants with normal hemoglobin A1c (HbA1c) showed more significant improvements in fasting glucose and triglycerides compared to those with intermediate HbA1c, indicating that baseline HbA1c levels may influence the effectiveness of lifestyle interventions on cardiometabolic health.
Does the Effect of a 3-Year Lifestyle Intervention on Body Weight and Cardiometabolic Health Differ by Prediabetes Metabolic Phenotype? A Post Hoc Analysis of the PREVIEW Study.Zhu, R., Jalo, E., Silvestre, MP., et al.[2022]
In a study of 522 overweight individuals with impaired glucose tolerance, long sleep duration (9-10 hours or more) was linked to a higher risk of developing type 2 diabetes, particularly in those who did not receive lifestyle intervention.
However, participants who underwent lifestyle interventions, including diet and exercise, did not show an increased diabetes risk associated with long sleep duration, suggesting that such interventions can mitigate the negative effects of excessive sleep on diabetes risk.
Sleep duration, lifestyle intervention, and incidence of type 2 diabetes in impaired glucose tolerance: The Finnish Diabetes Prevention Study.Tuomilehto, H., Peltonen, M., Partinen, M., et al.[2022]

Citations

Lifestyle and the Prevention of Type 2 Diabetes: A Status ...Randomized controlled trials have shown that lifestyle interventions focused on physical activity, healthy diets, and weight loss can reduce diabetes risk by 58 ...
Clinically Practical and Affordable Lifestyle Modification to ...A significantly higher percentage of patients in the intervention group achieved target levels for plasma glucose, blood pressure, BMI, and ...
Effectiveness of a community intervention program on ...The study found that a community-based lifestyle modification program significantly improved Health-Related Quality of Life (HRQoL) for individuals at high risk ...
Effects of lifestyle interventions on the prevention of type 2 ...We found lifestyle intervention was 44 % more effective than usual care in the reversion to normoglycemia, in line with the finding of Galaviz et al., reporting ...
The effectiveness of lifestyle interventions on type 2 ...Lifestyle interventions decreased the incidence risk ratio of type 2 diabetes by 25% (0·75 [95% CI 0·61 to 0·91]), and reduced the levels of ...
5. Facilitating Positive Health Behaviors and Well-being to ...For many individuals with overweight or obesity alongside type 2 diabetes, at least 5% weight loss is needed to achieve beneficial outcomes in ...
Diabetes Self-Management: Facilitating Lifestyle ChangeCurrent guidelines recommend long-term weight loss of 5% to 7% of body weight and 150 minutes of at least moderate-intensity physical activity per week.
Outcome of lifestyle intervention in relation to duration ...Compared with control, LI participants showed decrease in glucose, weight, and body fat; 42.8% reverted to NGR, 50% had persistent pre-diabetes, ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security