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
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|Condition or disease||Intervention/treatment||Phase|
|Pre Diabetes Insulin Resistance||Other: Dietary||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Dietary counseling based on results of CGM analyses.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Be 18 years of age or older;
- Not be pregnant, if female;
- 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.
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
|Contact: Alessandra Celli, PhD||(650) email@example.com|
|Contact: Dalia Perelman, MS, RD, CDEfirstname.lastname@example.org|
|United States, California|
|Stanford, California, United States, 94304|
|Contact: Michael Snyder, PhD|
|Contact: Dalia Perelman, MS, RD, CDE email@example.com|
|Sub-Investigator: Dalia Perelman, MS, RD, CDE|
|Principal Investigator:||Michael P Snyder, PhD||Stanford University|
|Principal Investigator:||Tracey McLaughlin, MD||Stanford University|
|Responsible Party:||Michael Snyder, Chair, Genetics Department, Stanford University|
|Other Study ID Numbers:||
|First Posted:||April 18, 2019 Key Record Dates|
|Last Update Posted:||May 10, 2022|
|Last Verified:||May 2022|
|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|
Glucose Metabolism Disorders
Endocrine System Diseases