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Dietary Interventions for Diabetes Prevention

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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
No Placebo-Only Group

Summary

This trial aims to prevent diabetes by creating personalized diet plans based on individual differences in how people develop the disease. It focuses on people with pre-diabetes or diabetes and uses biomarkers to diagnose and tailor diets early.

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in glycemic control as measured by change blood sugar values
Classification of metabolic subphenotype
Secondary study objectives
Change in area under the curve (AUC) of blood glucose level

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Optimizing Diet for Glycemic ControlExperimental Treatment1 Intervention
Phase 1: Metabolic testing will include 3 metabolic tests: 1. 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. 2. 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. 3. 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.

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.
Ileoanal pull-through: a new surgical alternative to ileostomy and a new challenge in diet therapy.Preventive Role of Diet Interventions and Dietary Factors in Type 2 Diabetes Mellitus: An Umbrella Review.The immunologic Warburg effect: Evidence and therapeutic opportunities in autoimmunity.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,487 Previous Clinical Trials
17,516,643 Total Patients Enrolled
30 Trials studying Insulin Resistance
2,486 Patients Enrolled for Insulin Resistance
National Human Genome Research Institute (NHGRI)NIH
270 Previous Clinical Trials
293,969 Total Patients Enrolled
Tracey McLaughlin, MDPrincipal InvestigatorStanford University
10 Previous Clinical Trials
684 Total Patients Enrolled
5 Trials studying Insulin Resistance
293 Patients Enrolled for Insulin Resistance
Michael P Snyder, PhDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
812 Total Patients Enrolled
~12 spots leftby Dec 2025