R01NR018916

Personalized Dietary Management in Type 2 Diabetes - Abstract

Hyperglycemia in Type 2 Diabetes (T2D) is associated with a variety of vascular complications of the disease, but clinical trials of medication regimens designed to achieve near-normal HbA1c have been disappointing and may even increase the risk of adverse outcomes due to polypharmacy.

Enhancing behavioral management of postprandial glycemia can further reduce glycemic exposure and downstream effects without the risks of polypharmacy. Postprandial glycemia is largely driven by dietary intake, but research findings regarding the best dietary approach to limit glycemic exposure are mixed and mostly negative. Studies done to date have used one-size-fits-all dietary regimens that do not take into consideration the fact that glycemic response is highly individual.

In this clinical trial of 255 (85/group) individuals with early-stage T2D, participants will be randomized to: (1) a social cognitive theory-based behavioral lifestyle intervention that includes a one-size-fits-all Mediterranean ADA diet (hereafter standardized), (2) standardized plus personalized dietary guidance to minimize postprandial glycemic response to meals (hereafter personalized), or (3) a usual care control plus (hereafter UCC).

We will compare the groups in terms of mean amplitude of glycemic excursion (MAGE). Hypothesis MAGEpersonalized < MAGEstandardized < MAGEUCC at 6 months. At each time point, we will describe between-group differences in HbA1c, β-cell function, and the need to escalate the medication regimen. We also will describe the impact of the interventions on alternative measures of glycemic variability (standard deviation, continuous overall net glycemic action, area under the curve, and frequency of out-of-range and seriously out-of-range glucose values). We will explore the relative contribution of glycemic variability and HbA1c to observed changes in β-cell function.

The proposed study is an integrative scientific undertaking, reflecting the input of experts in nursing, the behavioral sciences, computational biology, microbiome, mHealth technology, endocrinology, and nutrition for the development of personalized behavioral counseling to minimize glycemic exposure and disease progression in those with early-stage T2D.

New York University

NURSES UNDERSTAND THAT IMPROVING HEALTH AND WELL-BEING MEANS ADDRESSING PEOPLE'S NEEDS IN MULTIPLE SETTINGS, CONTEXTS, AND OVER THE WHOLE LIFE COURSE. SCIENCE SUPPORTED BY THE NATIONAL INSTITUTE OF NURSING RESEARCH (NINR) USES THIS HOLISTIC PERSPECTIVE TO IMPROVE INDIVIDUAL AND POPULATION HEALTH AND ADVANCE HEALTH EQUITY. NINR-SUPPORTED RESEARCH PROMOTES HEALTH AND WELL-BEING BY ADDRESSING NEEDS AT MULTIPLE LEVELS INDIVIDUAL, FAMILY, COMMUNITY, AND SOCIETAL LEVELS AND DEVELOPING TREATMENT AND PREVENTION STRATEGIES THAT ARE RESPONSIVE TO THE REALITY OF PEOPLE'S LIVES. NURSES KNOW PEOPLE, AND PEOPLE TRUST NURSES. PATIENT AND FAMILIES INTERACT WITH NURSES MORE THAN ANY OTHER CLINICIANS. NURSING SCIENCE USES THIS SPECIAL RELATIONSHIP TO BETTER UNDERSTAND PATIENTS, FAMILIES, AND COMMUNITIES AND THE MANY FACTORS THAT INFLUENCE THEIR HEALTH. NURSING SCIENCE SUPPORTED BY NINR USES THIS KNOWLEDGE TO DEVELOP STRATEGIES FOR IMPROVING HEALTH AND WELLNESS ACROSS POPULATIONS, HEALTH CARE SETTINGS, AND THE LIFESPAN, WITH AN EMPHASIS ON ACHIEVING HEALTH EQUITY. NINR-SUPPORTED SCIENTISTS HAVE DEVELOPED INTERVENTIONS FOR: SUPPORTING PARENTS OF PREMATURE INFANTS, PROMOTING HIV PREVENTION IN UNDERSERVED POPULATIONS, IMPROVING TRANSITIONAL CARE LEADING TO BETTER OUTCOMES AND COST-SAVINGS, AND HELPING INNER-CITY CHILDREN MANAGE ASTHMA. NURSING SCIENCE TRANSCENDS THE BOUNDARIES OF DISEASE AND RESEARCH DISCIPLINES TO BETTER UNDERSTAND THE EXPERIENCES OF INDIVIDUALS AND FAMILIES LIVING WITH ILLNESS AND TO DEVELOP PERSONALIZED APPROACHES THAT MAXIMIZE HEALTH AND WELL-BEING FOR INDIVIDUALS AT ALL STAGES OF LIFE, ACROSS DIVERSE POPULATIONS AND SETTINGS. NINR-SUPPORTED SCIENCE USES NURSING SCIENCE'S UNIQUE, PATIENT AND COMMUNITY-FOCUSED PERSPECTIVE AND WIDE REACH ACROSS CLINICAL AND COMMUNITY SETTINGS TO ADVANCE OUR UNDERSTANDING OF THE SOCIAL DETERMINANTS OF HEALTH: THOSE FACTORS THAT ARE AT THE ROOT OF THE INEQUITIES THAT WE SEE, SUCH AS FOOD INSECURITY AND ACCESS TO HEALTHCARE. NINR RESEARCH EFFORTS IN WELLNESS INVESTIGATE THE KEY BIOLOGICAL, BEHAVIORAL, AND SOCIAL FACTORS THAT PROMOTE LONG-TERM HEALTH AND HEALTHY BEHAVIORS AND PREVENT THE DEVELOPMENT OF ILLNESS ACROSS HEALTH CONDITIONS, SETTINGS, AND THE LIFESPAN. RESEARCH IN WELLNESS IS ALSO FOCUSED ON DEVELOPING AND TESTING CULTURALLY APPROPRIATE INTERVENTIONS TO PROMOTE HEALTH AND PREVENT ILLNESS IN MINORITY AND UNDERSERVED GROUPS. NINR ALSO SUPPORTS SCIENCE TO ASSIST INDIVIDUALS, FAMILIES, AND HEALTH CARE PROFESSIONALS IN MANAGING ADVANCED, SERIOUS ILLNESS, AND PLANNING FOR END-OF-LIFE DECISIONS. IN ADDITION, NINR PROMOTES TECHNOLOGICAL ADVANCEMENTS THAT ADDRESS A RANGE OF HEALTH CARE CHALLENGES AND FACILITATE THE DELIVERY OF REAL-TIME PERSONALIZED INFORMATION TO INDIVIDUALS AND FAMILIES, HEALTH CARE PROVIDERS, AND COMMUNITIES. FINALLY, NINR HAS A LONGSTANDING AND CONTINUING COMMITMENT TO DEVELOPING THE NEXT GENERATION OF NURSE SCIENTISTS: THOSE INDIVIDUALS AND TEAM MEMBERS WHO WILL CARRY THE FIELD OF NURSING SCIENCE INTO THE FUTURE. IN ORDER TO PREPARE AN INNOVATIVE, DIVERSE, AND TALENTED NEXT GENERATION OF NURSE SCIENTISTS, NINR SUPPORTS A VARIETY OF TRAINING OPPORTUNITIES FOR SCIENTISTS AND TRAINEES AT ALL CAREER LEVELS, PARTICULARLY THOSE AT AN EARLY CAREER STAGE WHO ARE SO CRITICAL TO SUSTAINING THE FUTURE OF INNOVATIVE RESEARCH AND HIGH QUALITY HEALTH CARE.

93.361 - Nursing Research

National Institute of Nursing Research (NINR) [HHS - NIH]

New York, New York 100165267 United States

Single Zip Code

Research Project Grant (Parent R01 Clinical Trial Required) (PA-19-055)

Amendment Since initial award the total obligations have increased 365% from $743,162 to $3,459,318.