Document text
Principal Investigator: Laura Saslow
Organization: UNIVERSITY OF MICHIGAN AT ANN ARBOR
Fiscal Year: 2024
Award: $328,977
Funding agency: National Institute of Diabetes and Digestive and Kidney Diseases
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 diabetes as the primary outcome.
Terms: <2 arm RCT><2 arm randomized control trial><2 arm randomized controlled trial><21+ years old><Adult><Adult Human><Adult-Onset Diabetes Mellitus><American><Amputation><Apoplexy><Blindness><Body Weight><Body Weight decreased><Body fat><Brain Vascular Accident><COVID-19 associated death><COVID-19 associated fatality><COVID-19 associated mortality><COVID-19 death><COVID-19 fatality><COVID-19 induced death><COVID-19 induced fatality><COVID-19 induced mortality><COVID-19 mortality><COVID-19 related death><COVID-19 related fatality><COVID-19 related mortality><COVID19 associated death><COVID19 associated fatality><COVID19 associated mortality><COVID19 death><COVID19 fatality><COVID19 induced death><COVID19 induced fatality><COVID19 induced mortality><COVID19 mortality><COVID19 related death><COVID19 related fatality><COVID19 related mortality><Caloric Restriction><Carbohydrates><Cardiac infarction><Centers for Disease Control><Centers for Disease Control and Prevention><Centers for Disease Control and Prevention (U.S.)><Cerebral Stroke><Cerebrovascular Apoplexy><Cerebrovascular Stroke><Clinical Trials><Communities><Country><Curriculum><Diabetes Mellitus><Diabetes prevention><Diet><Dietary Practices><Disease><Disorder><Drugs><Educational Curriculum><Educational process of instructing><Effectiveness><Fats><Fatty acid glycerol esters><Foundations><Glycohemoglobin A><Glycosylated hemoglobin A><Goals><Hb A1><Hb A1a+b><Hb A1c><HbA1><HbA1c><Health><Health Insurance for Aged and Disabled, Title 18><Health Insurance for Disabled Title 18><Hemoglobin A(1)><Hypoglycemic Agents><Hypoglycemic Drugs><Hypoglycemics><Incidence><Individual><Inflammation><Intake><Intervention><Intervention Strategies><Investigators><Ketosis-Resistant Diabetes Mellitus><Kidney><Kidney Urinary System><Lead><Life Style><Lifestyle><Maturity-Onset Diabetes Mellitus><Measures><Medicare><Medication><Methods><Michigan><Mission><Myocardial Infarct><Myocardial Infarction><NIDDK><NIDDM><National Institute of Diabetes and Digestive and Kidney Diseases><Non-Insulin Dependent Diabetes><Non-Insulin-Dependent Diabetes Mellitus><Noninsulin Dependent Diabetes><Noninsulin Dependent Diabetes Mellitus><Nutritional><Outcome><Over weight><Overweight><Participant><Pb element><Persons><Pharmaceutical Preparations><Physical activity><Population><Prediabetes><Prediabetes syndrome><Prediabetic State><Prevalence><Preventative strategy><Prevention strategy><Preventive strategy><Principal Investigator><Public Health><Randomization trial><Randomized><Randomized, Controlled Trials><Recommendation><Research><Research Personnel><Research Resources><Researchers><Resources><Review Committee><Risk><Risk Factors><Risk Reduction><SARS-CoV-2 associated death><SARS-CoV-2 associated fatality><SARS-CoV-2 associated mortality><SARS-CoV-2 death><SARS-CoV-2 fatality><SARS-CoV-2 induced death><SARS-CoV-2 induced fatality><SARS-CoV-2 induced mortality><SARS-CoV-2 mortality><SARS-CoV-2 related death><SARS-CoV-2 related fatality><SARS-CoV-2 related mortality><Site><Slow-Onset Diabetes Mellitus><Stable Diabetes Mellitus><Stroke><T2 DM><T2D><T2DM><Teaching><Testing><Title 18><Type 2 Diabetes Mellitus><Type 2 diabetes><Type II Diabetes Mellitus><Type II diabetes><United States><United States Centers for Disease Control><United States Centers for Disease Control and Prevention><Weight><Weight Loss><Weight Reduction><Work><acceptability and feasibility><adult adiposity><adult obesity><adult onset diabetes><adulthood><adults with obesity><antihyperglycemic><body weight loss><brain attack><caloric restricted><calorically restricted><calorie restricted><calorie restriction><cardiac infarct><care as usual><cerebral vascular accident><cerebrovascular accident><clinical practice><community partners><community-based partners><coronary attack><coronary infarct><coronary infarction><coronavirus disease 2019 associated death><coronavirus disease 2019 associated fatality><coronavirus disease 2019 associated mortality><coronavirus disease 2019 death><coronavirus disease 2019 fatality><coronavirus disease 2019 induced death><coronavirus disease 2019 induced fatality><coronavirus disease 2019 induced mortality><coronavirus disease 2019 mortality><coronavirus disease 2019 related death><coronavirus disease 2019 related fatality><coronavirus disease 2019 related mortality><coronavirus disease-19 mortality><death due to COVID-19><death due to COVID19><death due to SARS-CoV-2><death due to coronavirus disease 2019><death due to severe acute respiratory syndrome coronavirus 2><death in COVID><death in COVID-19><death in SARS-CoV-2><death in coronavirus disease><death in coronavirus disease 2019><death in severe acute respiratory syndrome coronavirus 2><design><designing><diabetes><diabetes prevention program><diabetes risk><diet adherence><diet restriction><dietary><dietary adherence><dietary pattern><dietary restriction><diets><drug/agent><effectiveness testing><efficacy testing><evidence base><fatality due to COVID-19><fatality due to COVID19><fatality due to SARS-CoV-2><fatality due to coronavirus disease 2019><fatality due to severe acute respiratory syndrome coronavirus 2><follow up assessment><followup assessment><glycemic control><health insurance for disabled><heart attack><heart infarct><heart infarction><heavy metal Pb><heavy metal lead><hemoglobin A1c><high risk><improved><interventional strategy><ketosis resistant diabetes><lesson plans><maturity onset diabetes><mortality due to COVID-19><mortality due to COVID19><mortality due to SARS-CoV-2><mortality due to coronavirus disease 2019><mortality due to severe acute respiratory syndrome coronavirus 2><multi-site trial><multisite trial><nutrition><nutritious><personalized health intervention><personalized intervention><pilot test><pre-diabetes><pre-diabetic><precision interventions><prediabetic><preservation><prevent><preventing><primary outcome><programs><randomisation><randomization><randomized control trial><randomized trial><randomly assigned><reduce risk><reduce risks><reduce that risk><reduce the risk><reduce these risks><reduces risk><reduces the risk><reducing risk><reducing the risk><renal><response><restricted diet><risk-reducing><secondary outcome><severe acute respiratory syndrome coronavirus 2 associated death><severe acute respiratory syndrome coronavirus 2 associated fatality><severe acute respiratory syndrome coronavirus 2 associated mortality><severe acute respiratory syndrome coronavirus 2 death><severe acute respiratory syndrome coronavirus 2 fatality><severe acute respiratory syndrome coronavirus 2 induced death><severe acute respiratory syndrome coronavirus 2 induced fatality><severe acute respiratory syndrome coronavirus 2 induced mortality><severe acute respiratory syndrome coronavirus 2 mortality><severe acute respiratory syndrome coronavirus 2 related death><severe acute respiratory syndrome coronavirus 2 related fatality><severe acute respiratory syndrome coronavirus 2 related mortality><stroked><strokes><tool><treatment as usual><two arm RCT><two arm randomized control trial><two arm randomized controlled trial><type 2 DM><type II DM><type two diabetes><usual care><vision loss><visual loss><weights><wt-loss>