Back to resultsPrecision Diets for Diabetes Prevention
Primary Purpose
Pre Diabetes, Insulin Resistance
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary
Sponsored by
About this trial
This is an interventional prevention trial for Pre Diabetes
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.
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Optimizing Diet for Glycemic Control
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in glycemic control as measured by change blood sugar values
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
Area under the curve (AUC) of blood sugar level as a measurement of maximum peak serum glucose.
Measured from baseline through all phases of the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03919877
Brief Title
Precision Diets for Diabetes Prevention
Official Title
Precision Diets for Diabetes Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2018 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes, Insulin Resistance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Optimizing Diet for Glycemic Control
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dietary
Intervention Description
Dietary counseling based on results of CGM analyses.
Primary Outcome Measure Information:
Title
Change in glycemic control as measured by change blood sugar values
Description
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.
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Area under the curve (AUC) of blood sugar level as a measurement of maximum peak serum glucose.
Description
Measured from baseline through all phases of the study.
Time Frame
Three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandra Celli, PhD
Phone
(650) 725-8491
Email
alessandra.celli@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dalia Perelman, MS, RD, CDE
Email
daliap@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P Snyder, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tracey McLaughlin, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Snyder, PhD
First Name & Middle Initial & Last Name & Degree
Dalia Perelman, MS, RD, CDE
Email
daliap@stanford.edu
First Name & Middle Initial & Last Name & Degree
Dalia Perelman, MS, RD, CDE
12. IPD Sharing Statement
Learn more about this trial
Precision Diets for Diabetes Prevention
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