What side effects are associated with this type of intervention?

Common treatments for prediabetes that target glucose metabolism or insulin sensitivity include metformin, GLP-1 receptor agonists (e.g., liraglutide, semaglutide), and SGLT2 inhibitors (e.g., dapagliflozin). Metformin is generally well-tolerated but can cause gastrointestinal side effects such as nausea, diarrhea, and abdominal discomfort. GLP-1 receptor agonists may lead to gastrointestinal issues like nausea and vomiting, and they require injections, which can be a barrier for some patients. SGLT2 inhibitors can cause urinary tract infections, genital infections, and, in rare cases, diabetic ketoacidosis. These treatments are effective in reducing HbA1c levels but come with their respective side effect profiles.

What prior FDA approvals exist?

The FDA has not approved many drugs specifically for the treatment of prediabetes. Metformin is one of the few medications that has been studied extensively and is often used off-label to improve insulin sensitivity and reduce HbA1c in individuals with prediabetes. Other drugs, such as GLP-1 receptor agonists like liraglutide, have shown potential benefits in glycemic control and weight loss, but they are not specifically approved for prediabetes. Lifestyle interventions remain the primary recommendation for managing prediabetes.

What other types of research exist?

Promising novel alternatives to VPNP for prediabetes patients include DPP-4 inhibitors like gemigliptin and sitagliptin, which have shown efficacy in reducing glycaemic variability and HbA1c. Additionally, GLP-1 receptor agonists and SGLT2 inhibitors are noteworthy due to their benefits in glucose metabolism and potential cardiovascular advantages.

← Back to Search

Dietary Supplement

Precision Nutrition Program for Diabetes

N/A

Waitlist Available

Led By Saadia Alvi, MD

Research Sponsored by Viome

Eligibility Criteria Checklist

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

Must have

Willing and able to use a smartphone and Viome app.

Be older than 18 years old

Must not have

Current (or previous) use of exogenous insulin (such as Tresiba, Lantus, Toujeo, Levemir, Humalog, Novolog, Apidra, Fiasp, etc.)

Significant surgery or medical procedure planned

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if personalized diet advice and supplements can lower blood sugar levels in people with slightly elevated blood sugar. People will follow tailored recommendations for three months, and their health will be checked before and after the trial.

Who is the study for?

This trial is for English-speaking adults aged 18 or older with HbA1c levels between 5.7% and 8.9%. Participants must be able to visit a Quest Diagnostics center, follow the nutrition program, use a smartphone with Viome's app, and not have used certain diabetes medications or been on specific diets recently.

What is being tested?

The trial is testing Viome's Precision Nutrition Program (VPNP) to see if it can lower HbA1c in people with diabetes or prediabetes. It's randomized and placebo-controlled, meaning some people will get VPNP while others won't, decided by chance.

What are the potential side effects?

Since this trial involves a nutrition program rather than medication, side effects may include changes in digestion or potential food allergies related to new diet components within the program.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can use a smartphone and the Viome app.

Exclusion Criteria

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

Select...

I am using or have used insulin injections for my diabetes.

Select...

I have a major surgery or medical procedure coming up.

Select...

I am taking (or have taken) medication that increases insulin.

Select...

I am currently taking diet pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

HbA1c Levels

Insulin Resistance

Secondary study objectives

BMI

Cardiovascular Risk

Cholesterol

+5 more

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: Viome's Precision Nutrition Program (VPNP)Experimental Treatment1 Intervention

Participants with HbA1c levels between 5.7-8.9% (inclusive) are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial.

Group II: PlaceboActive Control1 Intervention

Participants with HbA1c levels between 5.7-8.9% (inclusive) are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial.

0 / 5Eligibility 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, such as metformin, GLP-1 receptor agonists, and SGLT2 inhibitors, primarily target glucose metabolism and insulin sensitivity to reduce HbA1c levels. Metformin works by decreasing hepatic glucose production and improving insulin sensitivity, which helps lower blood glucose levels. GLP-1 receptor agonists enhance insulin secretion in response to meals, slow gastric emptying, and promote satiety, leading to better postprandial glucose control and weight loss. SGLT2 inhibitors reduce glucose reabsorption in the kidneys, leading to increased glucose excretion in the urine. These mechanisms are crucial for prediabetes patients as they help manage blood sugar levels, prevent progression to type 2 diabetes, and reduce associated cardiovascular risks.

Absolute treatment effects for the primary outcome and all-cause mortality in the cardiovascular outcome trials of new antidiabetic drugs: a meta-analysis of digitalized individual patient data.Efficacy and Safety of Novel Dipeptidyl-Peptidase-4 Inhibitor Evogliptin in the Management of Type 2 Diabetes Mellitus: A Meta-Analysis.Sitagliptin on Carotid Intima-Media Thickness in Type 2 Diabetes Mellitus Patients and Anemia: A Subgroup Analysis of the PROLOGUE Study.