Diabetes Prevention for Alzheimer's Disease
(DPPOS-4 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the potential link between pre-diabetes (early-stage diabetes) and type 2 diabetes with memory and thinking problems. Researchers aim to understand the causes of these issues and how to prevent or slow diseases like Alzheimer's. The study tests various strategies, including weight loss, lifestyle changes, physical activities, and the drug Metformin, which controls blood sugar levels. Individuals from a previous diabetes study who remain available might be suitable candidates. Those over 55 who can safely undergo an MRI (a type of brain scan) may join a special brain imaging part of the study.
As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new prevention strategies for Alzheimer's.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that programs focused on changing diet and increasing physical activity are generally safe and can help adults lose weight. Participants in these programs may also experience small improvements in heart health.
Studies have found that metformin is safe and effective for treating type 2 diabetes, even in children as young as 10. Some individuals might experience side effects like stomach or muscle pain. Serious side effects are rare but can include difficulty breathing or extreme tiredness.
Overall, both treatments are well-tolerated. The FDA has approved metformin for type 2 diabetes, indicating its safety for that purpose. Behavioral programs are widely used and have a strong safety record.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the Diabetes Prevention Program Outcomes Study because it explores a combination of interventions, like behavioral weight loss, lifestyle changes, and physical activity, alongside the medication metformin, to prevent diabetes. Unlike standard treatments that often focus solely on medication to manage blood sugar levels, this approach emphasizes comprehensive lifestyle modifications that could offer long-term benefits in reducing diabetes risk. Metformin, well-known for its role in glucose regulation, is now being studied in combination with these lifestyle strategies, aiming to enhance its effectiveness and potentially provide a more holistic approach to diabetes prevention. This trial might pave the way for a new standard where medication and lifestyle are integrated for better health outcomes.
What evidence suggests that this trial's treatments could be effective for cognitive impairment in pre-diabetes and type 2 diabetes?
Research has shown that the treatments studied in this trial yield promising results for similar conditions. Behavioral weight loss programs, which participants in this trial may receive, can lead to a significant 5% weight loss and are more effective when combined with diet and exercise. This method has helped individuals with pre-diabetes and type 2 diabetes manage their weight, which is crucial because these conditions can increase the risk of memory and thinking problems. Metformin, another treatment option in this trial, is a common diabetes medication that has lowered the risk of developing diabetes by 31% and helps reduce blood sugar levels. It also benefits heart health and overall survival. These findings suggest that the treatments may improve brain health in people with pre-diabetes and type 2 diabetes by addressing these underlying issues.13678
Who Is on the Research Team?
Jose Luchsinger
Principal Investigator
Columbia University
David Nathan
Principal Investigator
Massachusetts General Hospital
Marinell Temprosa
Principal Investigator
George Washington University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Comprehensive cognitive assessments and syndrome adjudication, including plasma and brain imaging biomarkers of AD/ADRD
Phenotyping and Data Collection
Two waves of state-of-the-art AD/ADRD phenotyping, including cognitive assessments and biomarker collection
Follow-up
Participants are monitored for cognitive decline, MCI, and dementia through ongoing assessments
What Are the Treatments Tested in This Trial?
Interventions
- Behavioral Weight Loss Intervention
- Lifestyle Intervention
- Metformin
- Physical Activity Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Marinella Temprosa
Lead Sponsor
National Institute on Aging (NIA)
Collaborator
Citations
Behavioral Lifestyle Interventions for Moderate and Severe ...
The results showed that the two groups that underwent behavioral intervention achieved greater percent weight losses than the fluoxetine group at 54 weeks (7.53 ...
Weight Loss in Short-Term Interventions for Physical ...
Short-term multicomponent interventions involving physical activity and nutrition can achieve weight loss for adults with overweight or obesity.
Diet or Exercise Interventions vs Combined Behavioral ...
The results provide good evidence that, on average, combined BWMPs are more beneficial than diet-only or physical activity-only interventions. However, it does ...
Behavioral Lifestyle Interventions for Weight Loss in ...
Our findings suggest that structured BLIs, characterized by frequent feedback and support, can lead to a clinically meaningful 5% weight loss.
Behavioral Counseling Interventions to Promote a Healthy ...
Diet and physical activity behavioral counseling interventions were associated with small, statistically significant reductions in continuous ...
Behavioral Weight Loss Interventions to Prevent Obesity ...
Behavior-based weight loss maintenance trials were designed to maintain weight loss by continuing dietary changes and physical activity.
Behavioral Counseling Interventions to Promote a Healthy ...
The USPSTF concludes with moderate certainty that behavioral counseling interventions have a small net benefit on CVD risk in adults without CVD risk factors.
Behavior‐change lifestyle interventions for the treatment of ...
This scoping review discusses optimal behavior-change lifestyle interventions in the treatment of overweight and obesity in children and adolescents.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.