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Optimizing Diet for Glycemic Control for Prediabetes

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Recruiting

Led By Tracey McLaughlin, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three years

Awards & highlights

Study Summary

This trial is investigating the different paths that people take when developing pre-diabetes and diabetes, in order to find a more personalized approach to prevention.

Who is the study for?

This trial is for adults over 18 who are not pregnant and do not have any major organ diseases, uncontrolled high blood pressure, or conditions affecting nutrient absorption like celiac disease. It's also important that participants haven't had significant weight changes recently, aren't heavy alcohol users, don't use weight loss drugs or follow specific diets, and haven't undergone bariatric surgery.Check my eligibility

What is being tested?

The study aims to understand how different people develop pre-diabetes and diabetes by looking at their individual physiological differences. Researchers will try to find biomarkers for early diagnosis and create personalized diet plans to prevent the onset of diabetes more effectively.See study design

What are the potential side effects?

Since this trial involves dietary interventions rather than medication or invasive procedures, side effects may include digestive discomfort depending on the participant's reaction to new diet regimens.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ four years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~four years

This trial's timeline: 3 weeks for screening, Varies for treatment, and four years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in glycemic control as measured by change blood sugar values

Classification of metabolic subphenotype

Secondary outcome measures

Change in area under the curve (AUC) of blood glucose level

Trial Design

1Treatment groups

Experimental Treatment

Group I: Optimizing Diet for Glycemic ControlExperimental Treatment1 Intervention

Phase 1: Metabolic testing will include 3 metabolic tests: The Oral Glucose Tolerance Test. The participant will wear the CGM while undergoing the OGTT + will be asked to repeat the test at home twice. The Insulin Sensitivity Test (Steady State Plasma Glucose). This test is designed to measure how well cells remove glucose from the blood in response to insulin. The Isoglycemic Intravenous Glucose Infusion (IIGI). This test is designed to measure the incretin hormone effect. Phase 2: Participants follow their own diet while using the CGM. 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,255 Total Patients Enrolled

National Human Genome Research Institute (NHGRI)NIH

263 Previous Clinical Trials

284,032 Total Patients Enrolled

Tracey McLaughlin, MDPrincipal InvestigatorStanford University

8 Previous Clinical Trials

429 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate tally of individuals engaging in this research project?

"Affirmative. Clinicaltrials.gov attests to this medical trial's continued recruitment of participants, with the initial post having been published on May 24th 2018 and the most recent update being delivered on May 9th 2022. At present, 100 people need to be enrolled across a single site for completion."

Answered by AI

Is enrollment for this research project still open?

"Affirmative. Clinicaltrials.gov lists this clinical trial as currently recruiting patients, with the original post dating back to May 24th 2018 and an update occurring on May 9th 2022. This research requires 100 people at a single site location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Precision Diets for Diabetes Prevention

Michael Snyder 2018. "Precision Diets for Diabetes Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03919877.

All > Prediabetes > Diabetes Type 2