PMID- 36176003 OWN - NLM STAT- MEDLINE DCOM- 20221003 LR - 20230607 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 23 IP - 1 DP - 2022 Sep 30 TI - Testing a very low-carbohydrate adaption of the Diabetes Prevention Program among adults with prediabetes: study protocol for the Lifestyle Education about prediabetes (LEAP) trial. PG - 827 LID - 10.1186/s13063-022-06770-3 [doi] LID - 827 AB - BACKGROUND: The Center for Disease Control and Prevention's National Diabetes Prevention Program (NDPP) aims to help individuals with prediabetes avoid progression to type 2 diabetes mellitus (T2DM) through weight loss. Specifically, the NDPP teaches individuals to follow a low-fat, calorie-restricted diet and to engage in regular physical activity to achieve >/= 5% body weight loss. Most NDPP participants, however, do not achieve this weight loss goal, and glycemic control remains largely unchanged. One promising opportunity to augment the NDPP's weight loss and glycemic effectiveness may be to teach participants to follow a very low-carbohydrate diet (VLCD), which can directly reduce post-prandial glycemia and facilitate weight loss by reducing circulating insulin and enabling lipolysis. To date, there have been no high-quality, randomized controlled trials to test whether a VLCD can prevent progression to T2DM among individuals with prediabetes. The aim of this study is to test the effectiveness of a VLCD version the NDPP (VLC-NDPP) versus the standard NDPP. We hypothesize the VLC-NDPP will demonstrate greater improvements in weight loss and glycemic control. METHODS: We propose to conduct a 12-month, 1:1, randomized controlled trial that will assign 300 adults with overweight or obesity and prediabetes to either the NDPP or VLC-NDPP. The primary outcome will be glycemic control as measured by change in hemoglobin A1c (HbA1c) from baseline to 12 months. Secondary outcomes will include percent body weight change and changes in glycemic variability, inflammatory markers, lipids, and interim HbA1c. We will evaluate progression to T2DM and initiation of anti-hyperglycemic agents. We will conduct qualitative interviews among a purposive sample of participants to explore barriers to and facilitators of dietary adherence. The principal quantitative analysis will be intent-to-treat using hierarchical linear mixed effects models to assess differences over time. DISCUSSION: The NDPP is the dominant public health strategy for T2DM prevention. Changing the program's dietary advice to include a carbohydrate-restricted eating pattern as an alternative option may enhance the program's effectiveness. If the VLC-NDPP shows promise, this trial would be a precursor to a multi-site trial with incident T2DM as the primary outcome. TRIAL REGISTRATION: NCT05235425. Registered February 11, 2022. CI - (c) 2022. The Author(s). FAU - Griauzde, Dina H AU - Griauzde DH AUID- ORCID: 0000-0002-2260-0299 AD - Department of Internal Medicine, University of Michigan Medical School, 2800 Plymouth Road, Building 16, Room 16-371C, Ann Arbor, MI, 48109-2800, USA. dhafez@med.umich.edu. AD - VA Ann Arbor Healthcare System, Ann Arbor, MI, USA. dhafez@med.umich.edu. AD - University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, USA. dhafez@med.umich.edu. FAU - O'Brien, Alison AU - O'Brien A AD - Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, MI, USA. FAU - Yancy, William S Jr AU - Yancy WS Jr AD - Department of Medicine, Duke University School of Medicine, Durham, NC, USA. FAU - Richardson, Caroline R AU - Richardson CR AD - University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, USA. AD - Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, USA. FAU - Krinock, Jamie AU - Krinock J AD - Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, MI, USA. FAU - DeJonckheere, Melissa AU - DeJonckheere M AD - University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, USA. AD - Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, USA. FAU - Isaman, Deanna J M AU - Isaman DJM AD - Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, MI, USA. FAU - Vanias, Kaitlyn AU - Vanias K AD - University of Wisconsin Hospitals and Clinics, Madison, WI, USA. FAU - Shopinski, Samuel AU - Shopinski S AD - National Kidney Foundation of Michigan, Ann Arbor, MI, USA. FAU - Saslow, Laura R AU - Saslow LR AD - University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, USA. AD - Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, MI, USA. LA - eng SI - ClinicalTrials.gov/NCT05235425 GR - P30 DK092926/DK/NIDDK NIH HHS/United States GR - R01 DK125792/DK/NIDDK NIH HHS/United States GR - P30 DK089503/DK/NIDDK NIH HHS/United States GR - P30 DK020572/DK/NIDDK NIH HHS/United States PT - Clinical Trial Protocol PT - Journal Article DEP - 20220930 PL - England TA - Trials JT - Trials JID - 101263253 RN - 0 (Blood Glucose) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Insulin) RN - 0 (Lipids) RN - 0 (Nitro Compounds) RN - 0 (Propiophenones) RN - 2138-40-1 (4-nitro-3-dimethylaminopropiophenone) SB - IM MH - Adult MH - Blood Glucose MH - *Diabetes Mellitus, Type 2/complications/diagnosis/prevention & control MH - Glycated Hemoglobin MH - Humans MH - Hypoglycemic Agents MH - Insulin MH - Life Style MH - Lipids MH - Nitro Compounds MH - *Prediabetic State/complications/diagnosis/therapy MH - Propiophenones MH - Randomized Controlled Trials as Topic MH - Weight Loss PMC - PMC9524018 OTO - NOTNLM OT - Diabetes Prevention Program OT - Dietary carbohydrate restriction OT - Prediabetes OT - Prevention OT - Type 2 diabetes OT - Very low-carbohydrate diet COIS- Alison O'Brien, William Yancy, Jamie Krinock, Melissa DeJonckheere, Deanna Isaman, Kaitlyn Vanias, Samuel Shopinski, and Laura report no conflicts of interest. Dina Griauzde has received consulting fees from the National Kidney Foundation of Michigan. Caroline Richardson has received funding from Blue Cross Blue Shield of Michigan and Twine Consulting LLC. EDAT- 2022/09/30 06:00 MHDA- 2022/10/04 06:00 PMCR- 2022/09/30 CRDT- 2022/09/29 23:55 PHST- 2022/07/25 00:00 [received] PHST- 2022/09/20 00:00 [accepted] PHST- 2022/09/29 23:55 [entrez] PHST- 2022/09/30 06:00 [pubmed] PHST- 2022/10/04 06:00 [medline] PHST- 2022/09/30 00:00 [pmc-release] AID - 10.1186/s13063-022-06770-3 [pii] AID - 6770 [pii] AID - 10.1186/s13063-022-06770-3 [doi] PST - epublish SO - Trials. 2022 Sep 30;23(1):827. doi: 10.1186/s13063-022-06770-3.