N/A
N=115
Precision Diets for Diabetes Prevention
Pre Diabetes · Insulin Resistance · Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT03919877 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Change in Glycemic Control as Measured by Change Blood Sugar Values — 88.9; 95.4; 90.8; 96.7 mg/dL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dietary (Other); Oral Food Challege (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycemic Control as Measured by Change Blood Sugar Values |
88.9; 95.4; 90.8; 96.7; 74.5; 41.7 | <0.001 sig |
| PRIMARY Area Under the Receiver Operating Characteristic (ROC) Curve - Classification of Metabolic Subphenotype |
0.951; 0.875; 0.877 | — |
| SECONDARY Change in Area Under the Curve (AUC) of Blood Glucose Level |
5175; 3000; 4076; 2379 | 0.01 sig |
Summary
With this study the investigators want to understand the physiological differences for people developing pre-diabetes and diabetes. The investigators hypothesize that different individuals go through different paths in the development of the disease. By understanding the personal mechanism for developing disease, the investigators will find a personalized approach to prevent that development. The investigators are also hoping to be able to find a biomarker that will pinpoint to the particular defect and thus, diagnose the problem at an earlier stage and have the information to give personalized diet recommendations to prevent the development of diabetes more effectively.
Eligibility Criteria
Inclusion Criteria
- Be 18 years of age or older;
- Not be pregnant, if female;
Exclusion Criteria
- Have major organ disease, hypertension defined as >160/100, pregnant/lactating, diabetogenic medications, malabsorptive disorders like celiac sprue, others, heavy alcohol use, use of weight loss medications or specific diets, weight change > 2 kg in the last three weeks, history of bariatric surgery.
- Any medical condition that physicians believe would interfere with study participation or evaluation of results.
- Mental incapacity a nd/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol.
Data sourced from ClinicalTrials.gov (NCT03919877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.