What side effects are associated with this type of intervention?

Common treatments for prediabetes, such as lifestyle interventions involving diet and exercise, can lead to weight loss and improved glycemic control but may also cause mild hypoglycemia. Pharmacologic treatments like metformin are generally well-tolerated but can cause gastrointestinal side effects such as nausea, diarrhea, and abdominal discomfort. GLP-1 receptor agonists like liraglutide may also be used and can cause gastrointestinal issues, including nausea and vomiting, and may require subcutaneous injections. Overall, these treatments are effective but require monitoring for potential side effects.

What prior FDA approvals exist?

The FDA has approved metformin for the prevention of type 2 diabetes in individuals with prediabetes. While other drugs like GLP-1 receptor agonists (e.g., liraglutide) have shown promise in reducing the progression to diabetes, they are not specifically FDA-approved for prediabetes. Lifestyle interventions, such as those promoted by the National Diabetes Prevention Program (NDPP), remain a key strategy for managing prediabetes.

What other types of research exist?

Promising alternatives to NDPP-Flex for prediabetes patients include: 1) GLP-1 receptor agonists, which have demonstrated efficacy in reducing cardiovascular events and improving glycemic control. 2) SGLT2 inhibitors, which also show benefits in glycemic control and cardiovascular outcomes. 3) Intensive lifestyle interventions, similar to the Diabetes Prevention Program, but with personalized and technology-assisted approaches. 4) Metformin, which remains a well-supported pharmacological option for prediabetes management.

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NDPP-Flex for Prediabetes (NDPP-Flex Trial)

N/A

Recruiting

Led By Natalie Ritchie

Research Sponsored by Denver Health and Hospital Authority

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

English- or Spanish-speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

NDPP-Flex Trial Summary

This trial is testing a new diabetes prevention program (NDPP-Flex) to see if it's better than the standard program at improving blood sugar levels, reducing diabetes risk, and helping people lose weight. The study will enroll 200 adults with prediabetes who are normal weight or overweight/obese.

Who is the study for?

This trial is for adults over 18 with prediabetes, indicated by an A1C level of 5.7-6.4%, who are patients at Denver Health and have a BMI ≥20 kg/m2 (or ≥18.5 kg/m2 if Asian). It's not open to those who've done NDPP before, take diabetes medication like metformin, are pregnant, or have been diagnosed with diabetes.Check my eligibility

What is being tested?

The study compares NDPP-Flex—a modified version of the National Diabetes Prevention Program—with the standard program to see which is better at improving blood sugar levels and helping more people reach normal blood sugar levels.See study design

What are the potential side effects?

Since this trial involves lifestyle interventions rather than medications, typical drug side effects aren't expected. However, participants may experience fatigue or muscle soreness from increased physical activity.

NDPP-Flex Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I speak English or Spanish.

NDPP-Flex Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

A1C

Secondary outcome measures

return to normoglycemia

NDPP-Flex Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NDPP-FlexExperimental Treatment1 Intervention

NDPP-Flex. The primary difference between NDPP-Flex and the standard NDPP is the approach to goal setting. In NDPP-Flex, coaches use the latest CDC-published curriculum, but adapted such that participants are encouraged to 1) set attainable, individually-tailored goals for risk-reduction, 2) adjust goals over time as needed, and 3) avoid all-or-nothing assessments of goal attainment. At each session, coaches provide a goal setting worksheet (see excerpt) with a simple, fillable format to better accommodate low literacy (e.g., "I will limit my soda and sugary drinks to __ per day").

Group II: National Diabetes Prevention ProgramActive Control1 Intervention

The Diabetes Prevention Program was a successful clinical trial demonstrating that intensive lifestyle support for weight loss reduced diabetes incidence by 58%. The intervention was translated into the National Diabetes Prevention Program (NDPP) and disseminated by the Centers for Disease Control and Prevention as a yearlong group-based program since 2012.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prediabetes include lifestyle interventions and oral antidiabetic drugs. Lifestyle interventions, such as diet and exercise, aim to achieve weight loss and improve insulin sensitivity. Oral antidiabetic drugs like metformin, thiazolidinediones, and alpha-glucosidase inhibitors work through different mechanisms to enhance glycemic control. Metformin reduces hepatic glucose production and increases insulin sensitivity, thiazolidinediones improve insulin sensitivity by acting on PPAR-gamma receptors, and alpha-glucosidase inhibitors slow carbohydrate absorption to reduce postprandial glucose spikes. These treatments are essential for prediabetes patients as they address insulin resistance and impaired glucose metabolism, helping to prevent the progression to type 2 diabetes.

Oral antidiabetic drugs and regression from prediabetes to normoglycemia: a meta-analysis.Clinical efficacy of new thiazolidinediones and glinides in the treatment of type 2 diabetes mellitus.