Lifestyle Changes for Prediabetes
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.12345Why 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?
Marie-Pierre St-Onge
Principal Investigator
Columbia University
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants track their sleep and wear a glucose monitor to measure glucose levels
Treatment
Participants are randomized to either maintain usual habits or stabilize lifestyle behaviors
Follow-up
Participants are monitored for changes in glucose control, body composition, and liver fat
What Are the Treatments Tested in This Trial?
Interventions
- Fixed Schedule
- Fixed Sleep
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Department of Health and Human Services
Collaborator