# Testing a very low-carbohydrate diet version of the Diabetes Prevention Program to reduce risk factors for type 2 diabetes

> **NIH NIH R01** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2022 · $589,417

## Abstract

ABSTRACT
One-third of U.S. adults have prediabetes and are at high risk of developing type 2 diabetes and its devastating
health consequences. The landmark Diabetes Prevention Program (DPP) trial demonstrated that a resource-
intensive, one-on-one program combining diet and physical activity changes, could reduce the 3-year risk of
type 2 diabetes by 58% compared with usual care. Consequently, the DPP is considered one of the best
examples of how a nutritional program can prevent disease, and the Centers for Disease Control and
Prevention (CDC) and others recommend the DPP as a first-line treatment for adults with prediabetes. The
CDC’s National Diabetes Prevention Program (NDPP) is an adaptation of the DPP trial curriculum, using
group-based delivery. It teaches participants to follow a low-fat, calorie-restricted diet, as this was the
prevailing dietary advice when the DPP trial was designed over 30 years ago. The NDPP is now available at
>1,500 sites throughout the United States and reimbursed by Medicare and other payors. Yet, despite
widespread availability, only 36% of participants achieve the program goal of ≥5% body weight loss and, when
measured, HbA1c reduces on average less than 0.1%. We hypothesize that adapting the NDPP to teach a
different dietary strategy—a very-low-carbohydrate diet (VLCD)—will increase the effectiveness of the NDPP
as a tool for type 2 diabetes risk reduction. Carbohydrate intake is the strongest factor impacting post-prandial
glycemia, and a VLCD—due to its ability to reduce glycemia, weight, and the need for anti-hyperglycemic
medications—is now recommended by the American Diabetes Association for treatment of type 2 diabetes. To
date, there are neither high-quality, randomized controlled trials testing how effective a VLCD is at reducing the
risk of type 2 diabetes among adults with prediabetes, nor randomized trials of VLCD versions of any DPP. To
begin to fill this critical gap, our team has developed and pilot tested a VLCD version of the NDPP (VLC-
NDPP), delivered by our CDC-recognized community partner, the National Kidney Foundation of Michigan.
Our findings demonstrate that a VLC-NDPP is feasible and acceptable. We now propose to conduct a 12-
month, 1:1, randomized trial that will assign 300 overweight or obese adults with prediabetes to either the
standard NDPP or the VLC-NDPP. The primary outcome is glycemic control (measured by HbA1c), with
secondary outcomes including body weight, body fat percentage, glycemic variability, and inflammation. We
will also explore the barriers to and facilitators of glycemic control and dietary adherence using mixed methods.
As the prevalence of type 2 diabetes and the understanding of personalized interventions continue to increase,
there is a critical need to provide additional effective options for population-level type 2 diabetes prevention
strategies. If the VLC-DPP shows promise, this trial would be a precursor to a multi-site trial with incidence of
type 2 dia...

## Key facts

- **NIH application ID:** 10468043
- **Project number:** 5R01DK125792-02
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** Laura Saslow
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $589,417
- **Award type:** 5
- **Project period:** 2021-08-15 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10468043

## Citation

> US National Institutes of Health, RePORTER application 10468043, Testing a very low-carbohydrate diet version of the Diabetes Prevention Program to reduce risk factors for type 2 diabetes (5R01DK125792-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10468043. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*