Clinical trial NCT03919877: Precision Diets for Diabetes Prevention
Official title: Precision Diets for Diabetes Prevention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pre Diabetes
Insulin Resistance
Diabetes Mellitus, Type 2
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Human Genome Research Institute (NHGRI)
First posted: 2019-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: At present, individuals with prediabetes or diabetes are grouped together as a single entity, but almost certainly they represent a mix of different gene-environment interactions that lead to one of four dominant physiologic mechanisms underlying their dysglycemia. 1- liver insulin resistance, 2- muscle insulin resistance, 3- impaired insulin secretion, 4- impaired incretin hormone secretion. Gaps that we are addressing here are extremely important - first, we will define a composite biomarker to identify different subphenotypes of prediabetes based on the four known physiologic mechanisms that contribute differentially in each individual to glucose elevations, which we hypothesize will also be reflected in their "glucotype". Importantly, because both continuous glucose monitor and administration of standardized meal testing and metabolic tests are not practical in the clinic, the development of a composite biomarker comprised of select multi-omics measures and clinical variables will enable clinicians and possibly patients (without clinician) to easily identify the specific diet that will yield optimal health results.

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.

Primary outcomes:
measure: Change in glycemic control as measured by change blood sugar values
timeFrame: Three years
measure: Classification of metabolic subphenotype
timeFrame: Four years
Secondary outcomes:
measure: Change in area under the curve (AUC) of blood glucose level
timeFrame: Three years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Michael P Snyder, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Tracey McLaughlin, MD
role: PRINCIPAL_INVESTIGATOR
References: