Dietary Strategies for Prediabetes

(iADAPT Trial)

Overseen By Omer Faruq, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Diabetes, Eating disorders, others

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

Compensation: Varies

Number of Visits: 20

30 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{2 6 7 8 9}

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

My BMI is over 27, or over 22 if I have a spinal cord injury.

I am at risk for type 2 diabetes.

Willing to complete requirements for participation

Exclusion Criteria

Pregnant, planning to become pregnant or breastfeeding

I am currently on medication for weight loss.

Medical history of Type 1 or 2 Diabetes, using exogenous insulin, using prescription or OTC weight loss medications within the past 3 months, current alcohol or drug abuse or dependence, smoker with unstable habits in the past 3 months, pacemaker or other life-threatening medical implant, eating disorder(s)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants are randomized to consume either a high or reduced carbohydrate diet

4 weeks

Baseline visit, Week 4 assessment

Adaptive Treatment

Responders continue with initial diet; Non-responders are re-randomized to additional interventions

12 weeks

Week 16 assessment

Follow-up

Participants are monitored for changes in glucose, body weight, and other health metrics

4 weeks

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?

Group I: Reduced Carbohydrate Diet Experimental Treatment 1 Intervention

Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with reduced carbohydrate diet plan.

Group II: High Carbohydrate Diet Experimental Treatment 1 Intervention

Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with high carbohydrate diet plan.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12350580/

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, ...

2. link.springer.com link.springer.com/article/10.1007/s00125-025-06560-x

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, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1043661825003391

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 ...

4. nature.com nature.com/articles/s41387-017-0006-9

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 ...

5. drc.bmj.com drc.bmj.com/content/4/1/e000258

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5409661/

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- ...

7. drc.bmj.com drc.bmj.com/content/5/1/e000354

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 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0899900714003323

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-or

Nutrition 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 ...