Dietary Strategies for Prediabetes
(iADAPT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine which weight loss program is most effective for individuals at risk of type 2 diabetes. Participants will begin with either a high carbohydrate diet or a reduced carbohydrate diet to assess which aids in weight loss. Those who lose at least 2.5% of their weight in 4 weeks will continue with their initial diet plan. If not, they will either add exercise counseling or try a time-restricted eating plan. This trial suits individuals with prediabetes, a BMI of 27 or higher, and a physical or mobility disability. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance weight loss strategies for those at risk of type 2 diabetes.
Do I need to stop my current medications to join the trial?
The trial requires that your medication type and dosage have been stable for at least 3 months if they affect body weight or appetite. If your medications meet this condition, you likely won't need to stop them.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both high and low carbohydrate diets have been studied for their safety and effectiveness. Studies have found that high carbohydrate diets can aid in weight loss and improve blood sugar and cholesterol levels, though they might not be as effective for long-term control of prediabetes.
In contrast, low carbohydrate diets are linked to better blood sugar control and improved insulin sensitivity. Research indicates that these diets can significantly lower hemoglobin A1c, which measures average blood sugar levels over time, and also promote weight loss. Studies with many participants have shown that low carbohydrate diets are generally well-tolerated and can help manage diabetes more effectively.
Overall, both diet plans are safe when healthcare providers monitor and adjust them. Participants in the study will receive support to help them safely adapt to either diet.12345Why are researchers excited about this trial?
Researchers are excited about these dietary strategies for prediabetes because they offer a personalized approach to managing blood sugar levels. Unlike standard treatments that often rely on medications, these strategies focus on dietary changes, specifically high carbohydrate and reduced carbohydrate diets, to promote weight loss and improve insulin sensitivity. This approach empowers individuals to take control of their health through lifestyle changes, potentially reducing the need for medication. Additionally, both diets are integrated into a group-based behavioral intervention, which can provide support and motivation, making it easier for people to stick to healthy eating habits.
What evidence suggests that this trial's dietary strategies could be effective for prediabetes?
This trial will compare the effects of a High Carbohydrate Diet with a Reduced Carbohydrate Diet for managing prediabetes. Research has shown that dietary changes can help manage prediabetes. For those consuming a high-carbohydrate diet, studies have produced mixed results. Some improvements in blood sugar were observed, but fewer participants reversed their prediabetes, with only about 33% returning to normal blood sugar levels. In contrast, a reduced carbohydrate diet has shown better outcomes. This approach not only aids in significant weight loss but also improves blood sugar control, with a noticeable drop in HbA1c, which measures average blood sugar over time. Overall, a low-carb diet appears more effective for managing prediabetes than a high-carb diet.26789
Who Is on the Research Team?
Christine Ferguson, PhD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for people with prediabetes, obesity, or related conditions who haven't had success with traditional weight loss methods. It's also open to those with disabilities. Participants should be at risk for type 2 diabetes and willing to follow a high or reduced carbohydrate diet.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
Participants are randomized to consume either a high or reduced carbohydrate diet
Adaptive Treatment
Responders continue with initial diet; Non-responders are re-randomized to additional interventions
Follow-up
Participants are monitored for changes in glucose, body weight, and other health metrics
What Are the Treatments Tested in This Trial?
Interventions
- High Carbohydrate Diet
- Reduced Carbohydrate Diet
Trial Overview
The study tests whether a high or reduced carbohydrate diet can help with weight loss in prediabetic individuals. After initial results, non-responders will get extra interventions like exercise counseling or time-restricted eating to see if these improve outcomes.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with reduced carbohydrate diet plan.
Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with high carbohydrate diet plan.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Citations
Effectiveness of Personalized Nutrition on Management ...
Fasting glucose showed no significant change (p = 0.12, 2 studies) in prediabetics, while PPGR improved significantly (–14.85 mg/dLxh, p < 0.01, ...
Long-term effects of dietary protein and carbohydrate ...
We found that a high-protein, lower-carbohydrate, low-GI diet was less effective for long-term prediabetes remission compared with a prudent, ...
The efficacy of dietary interventions for prediabetes ...
Literature suggested that prediabetes may be reversible through dietary interventions. Despite numerous meta-analyses evaluating the efficacies of dietary ...
Twelve-month outcomes of a randomized trial ...
In a 12-month trial, adults with elevated HbA1c and body weight assigned to an LCK diet had greater reductions in HbA1c, lost more weight, and reduced more ...
Remission of pre-diabetes to normal glucose tolerance in ...
(1) The HP diet resulted in 100% remission of pre-diabetes to normal glucose tolerance while the HC diet resulted in only 33% remission. To the ...
Impact of High-Carbohydrate Diet on Metabolic Parameters ...
HC diets are at least as effective as LC diets, leading to significant weight loss and a reduction in plasma glucose, HbA1c and low density lipoprotein- ...
Systematic review and meta-analysis of dietary ...
Conclusions Low to moderate carbohydrate diets have greater effect on glycemic control in type 2 diabetes compared with high-carbohydrate diets ...
Dietary carbohydrate restriction as the first approach in ...
Here we present 12 points of evidence supporting the use of low-carbohydrate diets as the first approach to treating type 2 diabetes and as the most effective ...
9.
diabetesjournals.org
diabetesjournals.org/care/article/42/5/731/40480/Nutrition-Therapy-for-Adults-With-Diabetes-orNutrition Therapy for Adults With Diabetes or Prediabetes
Reducing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia and may be applied ...
Other People Viewed
By Subject
By Trial
Related Searches
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.