What side effects are associated with this type of intervention?

Common treatments for diabetes that target glucose metabolism or insulin sensitivity include metformin, GLP-1 receptor agonists, SGLT2 inhibitors, and DPP-4 inhibitors. Metformin is generally well-tolerated but can cause gastrointestinal issues such as diarrhea and nausea. GLP-1 receptor agonists may lead to gastrointestinal side effects like nausea and vomiting, and have been associated with weight loss. SGLT2 inhibitors can cause urinary tract infections and genital infections due to increased glucose in the urine. DPP-4 inhibitors are generally well-tolerated but can cause nasopharyngitis and, in rare cases, pancreatitis. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of type 2 diabetes that target glucose metabolism or insulin sensitivity to reduce HbA1c. These include DPP-4 inhibitors (e.g., sitagliptin), GLP-1 receptor agonists (e.g., liraglutide), and SGLT2 inhibitors (e.g., dapagliflozin). These medications have demonstrated efficacy in lowering HbA1c and improving glycemic control. Some, like GLP-1 receptor agonists and SGLT2 inhibitors, have also shown cardiovascular benefits, making them valuable options for patients with type 2 diabetes.

What other types of research exist?

Promising novel alternatives to VPNP for reducing HbA1c in diabetes patients include: 1) Biphasic Aspart 30 (BiAsp30), which is an effective alternative to premixed human insulin 30/70. 2) Evogliptin, a DPP-4 inhibitor, which has shown efficacy in reducing HbA1c in meta-analyses. 3) GLP-1 receptor agonists, which have demonstrated cardiovascular benefits and glucose-lowering effects. 4) SGLT2 inhibitors, which have shown reductions in cardiovascular events and glucose levels. These alternatives target glucose metabolism and insulin sensitivity effectively.

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Dietary Supplement

Precision Nutrition Program for Diabetes

N/A

Recruiting

Led By Momchilo Vuyisich

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

Significant surgery or medical procedure planned

Current (or previous) use of medications that increase insulin (sulfonylureas, such as glimepiride, glipizide, glyburide, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Summary

This trial tests if tailored nutrition and supplements can help people with moderately high blood sugar. Participants will follow specific diet plans and take special supplements for a few months. The goal is to see if these treatments can improve their blood sugar control.

Who is the study for?

This trial is for individuals with diabetes interested in seeing if a personalized nutrition program can help lower their HbA1c levels, which is an indicator of blood sugar control. Details on specific inclusion and exclusion criteria are not provided.

What is being tested?

The study tests Viome's Precision Nutrition Program (VPNP) to see if it effectively reduces HbA1c levels in diabetic patients. It's a randomized trial where participants will be chosen by chance to receive either the VPNP or a placebo.

What are the potential side effects?

Since this trial involves a nutrition program, side effects may include changes in digestion or dietary reactions. However, specific side effects related to Viome's Precision Nutrition Program are not detailed.

Eligibility Criteria

Inclusion Criteria

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

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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:

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I have a major surgery or medical procedure coming up.

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

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I am currently using or have used insulin injections.

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

Fasting Insulin levels

HbA1c levels

Secondary study objectives

BMI

Cardiovascular Risk

Cholesterol

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

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

Participants with HbA1c levels between 6.5-8.9% (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 6.5-8.9% (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 / 4Eligibility 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 diabetes that target glucose metabolism or insulin sensitivity include DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors. DPP-4 inhibitors increase incretin levels, enhancing insulin secretion and reducing glucagon levels. GLP-1 receptor agonists mimic the incretin hormone GLP-1, boosting insulin secretion, inhibiting glucagon release, and slowing gastric emptying. SGLT2 inhibitors prevent glucose reabsorption in the kidneys, increasing glucose excretion in urine. These mechanisms are vital for diabetes patients as they improve glycemic control, lower HbA1c levels, and reduce the risk of complications.

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.Assessing the impact of a new delivery method of insulin on glycemic control using a novel trial design.

Find a Location

Who is running the clinical trial?

ViomeLead Sponsor

21 Previous Clinical Trials

37,587 Total Patients Enrolled

2 Trials studying Diabetes

2,964 Patients Enrolled for Diabetes

Momchilo VuyisichPrincipal InvestigatorViome

12 Previous Clinical Trials

2,812 Total Patients Enrolled

1 Trials studying Diabetes

52 Patients Enrolled for Diabetes

~18 spots leftby Dec 2024

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