What is the mechanism of action of this treatment?

Common treatments for prediabetes include lifestyle modifications such as dietary changes and increased physical activity. A very low-carbohydrate diet, which is being studied in trials, works by significantly reducing carbohydrate intake, leading to lower blood glucose levels and promoting weight loss. This diet helps to decrease insulin resistance and improve glycemic control by minimizing the glucose spikes that typically follow carbohydrate consumption. For prediabetes patients, these mechanisms are crucial as they can prevent the progression to type 2 diabetes and reduce the risk of associated complications.

What side effects are associated with this type of intervention?

Very low-carbohydrate diets, which are often used to improve blood glucose control and promote weight loss in prediabetes, can have side effects such as nutrient deficiencies, constipation, headache, bad breath, muscle cramps, and fatigue. Pharmacologic treatments like metformin, which is commonly used for prediabetes, may cause gastrointestinal issues such as nausea, diarrhea, and abdominal discomfort. It is important for patients to discuss these potential side effects with their healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has not specifically approved any drugs solely for the treatment of prediabetes. However, lifestyle interventions, including dietary changes such as very low-carbohydrate diets, are commonly recommended to improve blood glucose control and promote weight loss. These dietary approaches aim to reduce carbohydrate intake, which can help lower blood sugar levels and support weight management. While medications like metformin are sometimes used off-label to manage prediabetes, the primary focus remains on lifestyle modifications.

What other types of research exist?

Promising alternatives to a very low-carbohydrate diet for prediabetes patients include: 1) GLP-1 agonists, which are associated with moderate weight loss and improved glycemic control; 2) SGLT2 inhibitors, which also promote weight loss and improve blood glucose levels; 3) DPP-4 inhibitors, which offer sustainable reductions in HbA1c with a low risk of hypoglycemia and no weight gain. These options provide effective glycemic control and additional benefits such as weight management.

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Diabetes Prevention Programs for Prediabetes (LEAP Trial)

N/A

Waitlist Available

Led By Laura Saslow, PhD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Inability to read, write, or speak English

Difficulty chewing or swallowing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two diet programs to see which one better helps people with prediabetes control their blood sugar and lose weight. One program follows a regular diet, while the other focuses on eating very few carbohydrates. Participants will also attend group classes for support and education.

Who is the study for?

The Leap Study is for adults with prediabetes, indicated by an HbA1c level between 5.7% and 6.4%. Participants should be overweight, able to do light exercise like walking, have their doctor's approval, and be willing to attend group sessions and adhere to a diet plan. People using certain medications or with specific health conditions are excluded.

What is being tested?

This study compares two approaches within the Diabetes Prevention Program: a standard method versus a very low-carbohydrate diet in improving blood sugar control and weight loss. Participants will be randomly assigned to one of these diets for a year with support through weekly online classes that later become monthly.

What are the potential side effects?

While not explicitly listed, potential side effects may include changes in digestion due to dietary adjustments (like constipation or bloating), possible nutrient deficiencies if the diet isn't well-balanced, and initial symptoms of carbohydrate withdrawal such as fatigue or irritability.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot read, write, or speak English.

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I have trouble chewing or swallowing.

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I am taking diabetes medication that is not metformin.

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I am taking warfarin.

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I have not been treated for an eating disorder or severe mental health issues like depression with thoughts of suicide, bipolar disorder, or schizophrenia.

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I am not using any anti-obesity drugs or participating in another weight loss program.

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I have a blood condition that affects my HbA1c levels.

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I am taking a water pill (diuretic) equivalent to 20mg or more of furosemide.

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I have a history of diabetes (type 1 or type 2).

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I have had or plan to have weight loss surgery during the study.

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My kidney function is severely reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Body Weight Changes

Change in Inflammation based on C-reactive protein (CRP)

Change in glycemic variability

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Very low-carbohydrate diet (VLCD)Experimental Treatment1 Intervention

VLCD is an adaptation of the standard NDPP curriculum, which preserves all features with the exception of altered dietary advice.

Group II: Standard NDPPActive Control1 Intervention

12-month long, calorie-restricted NDPP

0 / 11Eligibility 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 modifications such as dietary changes and increased physical activity. A very low-carbohydrate diet, which is being studied in trials, works by significantly reducing carbohydrate intake, leading to lower blood glucose levels and promoting weight loss. This diet helps to decrease insulin resistance and improve glycemic control by minimizing the glucose spikes that typically follow carbohydrate consumption. For prediabetes patients, these mechanisms are crucial as they can prevent the progression to type 2 diabetes and reduce the risk of associated complications.

The DAPA-DIET study: Metabolic response to Dapagliflozin combined with dietary carbohydrate restriction in patients with Type 2 Diabetes Mellitus and Obesity-A longitudinal cohort study.Do Cinnamon Supplements Have a Role in Glycemic Control in Type 2 Diabetes? A Narrative Review.Revisiting weight reduction and management in the diabetic patient: Novel therapies provide new strategies.