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Precision Diets for Diabetes Prevention

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ClinicalTrials.gov Identifier: NCT03919877
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
Michael Snyder, Stanford University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pre Diabetes Insulin Resistance Other: Dietary Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Precision Diets for Diabetes Prevention
Actual Study Start Date : May 24, 2018
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023
Arms and Interventions
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Arm Intervention/treatment
Optimizing Diet for Glycemic Control

All individuals will go through all the phases of the study.

Phase 1: Metabolic testing to determine insulin resistance status.

Phase 2: Participants follow their own diet while using the CGM (continuous glucose monitor). 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. Participants use the CGM for another cycle of 2-3 weeks to assess effectiveness of the recommendations. Blood is drawn for analyses before and after this cycle.

 Other: Dietary
Dietary counseling based on results of CGM analyses.


Outcome Measures
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Primary Outcome Measures :
  1. Change in glycemic control as measured by change blood sugar values [ Time Frame: Three years ]
    Change in glycemic control measured from baseline through all phases of study. Glycemic control is derived from continuous glucose monitor (CGM) data and expressed in milligrams/deciliter.


Secondary Outcome Measures :
  1. Area under the curve (AUC) of blood sugar level as a measurement of maximum peak serum glucose. [ Time Frame: Three years ]
    Measured from baseline through all phases of the study.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919877


Contacts
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Contact: Alessandra Celli, PhD (650) 725-8491 alessandra.celli@stanford.edu
Contact: Dalia Perelman, MS, RD, CDE daliap@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94304
Contact: Michael Snyder, PhD         
Contact: Dalia Perelman, MS, RD, CDE       daliap@stanford.edu   
Sub-Investigator: Dalia Perelman, MS, RD, CDE         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Michael P Snyder, PhD Stanford University
Principal Investigator: Tracey McLaughlin, MD Stanford University
More Information
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Responsible Party: Michael Snyder, Chair, Genetics Department, Stanford University
ClinicalTrials.gov Identifier: NCT03919877    
Other Study ID Numbers: 43883
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus
Insulin Resistance
Prediabetic State
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism