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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Precision Diets for Diabetes Prevention

Clinicaltrials.gov identifier NCT03919877

Recruitment Status Recruiting

First Posted April 18, 2019

Last update posted October 29, 2019

Study Description

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:Pre Diabetes
    Insulin Resistance
  • Intervention/Treatment: Other: Dietary
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Prevention
  • Official Title: Precision Diets for Diabetes Prevention
  • Actual Study Start Date: May 2018
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: May 2021
Arms and interventions
Arm Intervention/treatment
Other: 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
  • 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
  • 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
Contacts

Contact: Michael Snyder, PhD (650) 723-4668 mpsnyder@stanford.edu

Contact: Dalia Perelman, MS, RD, CDE daliap@stanford.edu

Locations

United States, California
Stanford University
Stanford

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Michael P Snyder, PhD Stanford University

More Information
  • Responsible Party: Stanford University
  • ClinicalTrials.gov Identifier: NCT03919877 History of Changes
  • Other Study ID Numbers: 43883
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: October 29, 2019
  • Last Verified: September 2019
  • 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: Diabetes Mellitus
    Insulin Resistance
    Prediabetic State