What side effects are associated with this type of intervention?

Common treatments for prediabetes include lifestyle changes such as diet and exercise, and medications like metformin. Dietary changes generally have minimal side effects but can include gastrointestinal discomfort if fiber intake is increased rapidly. Metformin can cause gastrointestinal issues such as nausea, diarrhea, and abdominal discomfort. Alpha-glucosidase inhibitors (e.g., acarbose) can also cause gastrointestinal side effects, including flatulence and diarrhea. Overall, lifestyle interventions are preferred due to their minimal side effects compared to pharmacological treatments.

What prior FDA approvals exist?

The FDA has not specifically approved any drugs solely for the treatment of prediabetes. However, lifestyle interventions, including personalized diet recommendations, are commonly recommended to manage prediabetes. These interventions focus on dietary changes, weight loss, and increased physical activity to prevent the progression to type 2 diabetes. While medications like metformin are sometimes used off-label for prediabetes, the primary approach remains non-pharmacologic, emphasizing tailored dietary and lifestyle modifications based on individual physiological mechanisms and biomarkers.

What other types of research exist?

Promising novel alternatives to personalized diet recommendations for prediabetes patients in 2024 include: 1) Pharmacological agents such as GLP-1 receptor agonists and SGLT2 inhibitors, which have shown efficacy in improving glycemic control and promoting weight loss. 2) Digital health interventions, including mobile apps and wearable devices, that provide real-time feedback and support for lifestyle changes. 3) Time-restricted eating and intermittent fasting, which have demonstrated benefits in improving insulin sensitivity and reducing body weight. 4) Gut microbiome modulation through probiotics and prebiotics, which may influence glucose metabolism and inflammation. 5) Comprehensive lifestyle intervention programs that combine diet, physical activity, and behavioral therapy tailored to the individual's needs and preferences.

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Optimizing Diet for Glycemic Control for Prediabetes

N/A

Recruiting

Led By Tracey McLaughlin, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three years

Awards & highlights

Study Summary

This trial is investigating the different paths that people take when developing pre-diabetes and diabetes, in order to find a more personalized approach to prevention.

Who is the study for?

This trial is for adults over 18 who are not pregnant and do not have any major organ diseases, uncontrolled high blood pressure, or conditions affecting nutrient absorption like celiac disease. It's also important that participants haven't had significant weight changes recently, aren't heavy alcohol users, don't use weight loss drugs or follow specific diets, and haven't undergone bariatric surgery.Check my eligibility

What is being tested?

The study aims to understand how different people develop pre-diabetes and diabetes by looking at their individual physiological differences. Researchers will try to find biomarkers for early diagnosis and create personalized diet plans to prevent the onset of diabetes more effectively.See study design

What are the potential side effects?

Since this trial involves dietary interventions rather than medication or invasive procedures, side effects may include digestive discomfort depending on the participant's reaction to new diet regimens.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ four years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~four years

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

Treatment Details

Study Objectives

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

Primary outcome measures

Change in glycemic control as measured by change blood sugar values

Classification of metabolic subphenotype

Secondary outcome measures

Change in area under the curve (AUC) of blood glucose level

Trial Design

1Treatment groups

Experimental Treatment

Group I: Optimizing Diet for Glycemic ControlExperimental Treatment1 Intervention

Phase 1: Metabolic testing will include 3 metabolic tests: The Oral Glucose Tolerance Test. The participant will wear the CGM while undergoing the OGTT + will be asked to repeat the test at home twice. The Insulin Sensitivity Test (Steady State Plasma Glucose). This test is designed to measure how well cells remove glucose from the blood in response to insulin. The Isoglycemic Intravenous Glucose Infusion (IIGI). This test is designed to measure the incretin hormone effect. Phase 2: Participants follow their own diet while using the CGM. Participants are provided with 5-10 standardized foods to test during this phase. Phase 3: Participants are provided with additional standardized foods and counseled to continue their own diet during this phase. Phase 4: Participants are counseled on reducing or limiting the foods that caused glucose spikes and they are also counseled on macronutrient composition of their diet based on lipid profile.

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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 often involve dietary interventions aimed at improving insulin sensitivity and reducing blood glucose levels. Personalized diet recommendations, which tailor dietary interventions based on individual physiological mechanisms and biomarkers, are particularly promising. These diets can target specific pathways such as insulin resistance or beta-cell dysfunction. For instance, a Mediterranean diet can enhance insulin sensitivity and reduce inflammation, while low-carbohydrate diets can lower blood glucose levels by reducing carbohydrate intake. Such personalized approaches are crucial for prediabetes patients as they offer a more precise and potentially more effective means of preventing the progression to type 2 diabetes.

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Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,408 Previous Clinical Trials

17,343,352 Total Patients Enrolled

National Human Genome Research Institute (NHGRI)NIH

263 Previous Clinical Trials

284,049 Total Patients Enrolled

Tracey McLaughlin, MDPrincipal InvestigatorStanford University

8 Previous Clinical Trials

429 Total Patients Enrolled

~6 spots leftby Dec 2024

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