Prediabetes Stratification by Multi-omics Profile After Food Intake

NCT06005051 | Withdrawn

• 1 other identifier: 68475
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

1 in 3 adults have prediabetes in the United States, and many of them will eventually develop diabetes, which has significant public health and economic costs. However, type 2 diabetes (T2D) and prediabetes are heterogeneous groups with different pathological mechanisms, dysfunctions in different processes, and varied disease trajectories. Patient stratifications into subtypes and personalized nutrition interventions are highly needed but not yet available. Metabolic responses (e.g., glucose excursion) after food intake provide a direct observation of personal metabolic control and its association with T2D. The investigators hope to learn how prediabetes and type 2 diabetes evolve, and specifically what food or exercise can do to mitigate blood sugar response.

Conditions

Diabetes Mellitus, Type 2; PreDiabetes

Outcome Measures

Primary Outcomes (2)

• Comparison of blood glucose levels after the different dietary and exercise mitigators

  Blood glucose value is derived from continuous glucose monitor (CGM) data, expressed in milligrams/deciliter, and measured for 10 days. Comparisons will be made between different mitigators (food and exercise) before and after consuming a standard rice meal.

  10 days

• Changes in postprandial metabolites response as measured by micro-sampling

  Dry blood samples will be collected by micro-sampling frequently before and after the standardized meals at 5 time points. Based on those samples, metabolomics (e.g., short-chain fatty acids, amino acids and other polar and nonpolar metabolites) will be extracted and quantified by liquid chromatography mass spectrometry (LC-MS). Both hydrophilic interaction LC and reverse phase LC will be used. Q Exactive will be used for MS. Tandem MS will be collected for annotation. Relative quantification will be used, where the level of metabolites can be compared between samples. Chemical reference will be used for the absolute quantification of targeted metabolites. Comparisons will be made between different mitigators (food and exercise) before and after consuming a standard rice meal.

  10 days

Secondary Outcomes (3)

• Changes in postprandial proteomic responses as measured in micro-sampling by Olink

  10 days

• Changes in personal metabolic states through the day as measured in micro-sampling by targeted and untargeted metabolomics (LC-MS)

  10 days

• Changes in personal metabolic states through the day as measured in micro-sampling by Olink proteomics

  10 days

Study Arms (1)

mitigator

EXPERIMENTAL

Test different foods to see their mitigating effect on blood sugars after a rice meal.

Other: Dietary intervention

Interventions

Dietary intervention OTHER

Using different combination of foods to see if the glucose response to a load of carbohydrates can be mitigated.

mitigator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 years of age or older;
• Not be pregnant;
• Live close to Stanford Campus
• Be generally healthy (with no apparent symptoms at the time of enrollment)
• Patients with prediabetes or diet-controlled or type 2 diabetes or controlled with metformin, will also be allowed to participate.
• Be willing to provide written informed consent for all study procedures.-

You may not qualify if:

• Major organ diseases,
• Pregnant or lactating. If a participant will become pregnant while in the study, she will be removed from the study.
• have malabsorptive disorders like celiac sprue or similar
• report 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 our physician believes would interfere with study participation or evaluation of results.
• Mental incapacity and/or cognitive impairment on the part of the patient that would preclude the adequate understanding of, or cooperation with, the study protocol.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Yue Wu, PhD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Scholar

Model Details: All participants will consume the meals using the cgm and fitbit devices and log their meal intake.

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 22, 2023
• Study Start: February 1, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)