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Persons with Type 2 Diabetes (T2D) are at an increased risk of cardiovascular disease (CVD) and mortality. Dietary changes are recommended by guidelines to treat T2D and reduce risk of CVD. Plant-based diets eliminate certain (i.e. vegetarian diet) or eliminate all animal based products (i.e. vegan diet). Clinical trials with plant-based diets have not looked at incidence of CVD as a (primary) outcome, but at intermediate outcomes of cardiovascular risk. A meta-analysis of 8 trials including 369 persons with T2D found an effect of a plant-based diet on glycated hemoglobin (HbA1c) of -0.29% [95% CI: -0.45, -0.12%] relative to mostly (omnivorous) low-fat diets or usual diet. The 95%CI ranged from what the authors had defined as clinically trivial to clinically relevant. For lipids, a network meta-analysis in persons with T2D compared the effect of a plant-based diet to a (omnivorous) low fat diet (274 patients allocated to a plant-based diet vs 2047 patients allocated to low fat diets). Compared to omnivorous low fat diets, the mean effect of plant-based diets on LDL-Cholesterol was -0.33 mmol/L [95%CI:- 0.55, - 0.12]. However, the quality of the evidence for this estimate was graded as low, mainly due to imprecision and within-study-bias. Furthermore, plant-based diets might reduce blood pressure (BP). However, while vegetarian diets reduce BP in patients with and without hypertension, for vegan diets the effect was only significant in patients with a systolic BP>130mmHgz (see section 1.4.3). Additionally, the effect of plant-based diets on inflammation, which might also be causally related to CVD risk in persons with T2D, has not been reported in trials with persons with T2D. Furthermore, most clinical trials of plant-based diets in persons with T2D have used resource intensive interventions, like weekly group meetings and cooking sessions. The effect of an online plant-based dietary intervention, which is more scalable, has not been reported in clinical trials. Lastly, factors influencing adherence in these trials have not been reported.
In summary, plant-based diets likely lower CVD risk by lowering HbA1c, LDL cholesterol and potentially blood pressure in persons with T2D. However, estimated effect sizes are imprecise and the effect on inflammation is still unknown. Furthermore, trials to date have used resource intensive interventions. Thus, the present trial aims to study the effect of a primarily online plant-based dietary program on (cardio)vascular risk factors in persons with T2D. Additionally, adherence and factors influencing adherence will be investigated. Participants will be randomized to the intervention or control group. The intervention group will be guided to transition to a plant-based dietary pattern using an online platform and online sessions. Researchers will compare the intervention group to the control group, that continues with usual diet, to see if the cardiovascular risk profile of the intervention group improves.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| An online 12 week plant-based dietary program | Experimental |
| |
| Usual Diet | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12-week plant-based dietary program | Behavioral | a 12-week plant-based dietary program consisting of information via an online platform, online guidance by dieticians and in online peer support groups. Patients will aim to maximize their intake of plant-based products while reducing their of animal products as much as possible. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (mmol/mol) | Week 12 | |
| Composite of Estimated relative CVD risk (based on change in LDL-c , SBP and HbA1c) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Calculated absolute CVD risk reduction (%) | Using baseline parameters (e.g. baseline LDL-C, BP, HbA1c, manifest CVD, duration of diabetes) and the risk prediction model DIAL2/SCORE-2(OP), the absolute CVD risk at baseline is calculated. The expected absolute risk reduction is calculated using changes in CVD risk profile after 12 and 24 weeks | Week 12, 24 and 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Subgroup analysis | Subgroups will be made on the basis of baseline characteristics (e.g. age, level of education, gender, presence of hypertension, duration of T2D, use of insulin, BMI, HbA1c) | Week 12 and 24 |
| Effect modification by diabetes subtype and adherence to the plant-based diet |
Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| F.L.J. Visseren, MD PhD | Contact | +31 88 7555555 | f.l.j.visseren@umcutrecht.nl | |
| Lukas Hoes, MD | Contact | l.l.f.hoes-4@umcutrecht.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Vascular Medicine UMC Utrecht | Recruiting | Utrecht | 3584 CX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41935557 | Derived | Hoes LLF, Geleijnse JM, Bemelmans RHH, Muller AF, de Ranitz-Greven WL, van Sloten T, Visseren FLJ, Koopal C. An online, predominantly plant-based, dietary intervention for improving cardiovascular risk: A randomized controlled trial in people with type 2 diabetes. Am Heart J. 2026 Aug;298:107436. doi: 10.1016/j.ahj.2026.107436. Epub 2026 Apr 2. |
| Label | URL |
|---|---|
| Plate-DM UMC Utrecht | View source |
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Request for IPD should be directed to the PI. The PI will judge whether request are appropriate and can be granted within the existing rules and regulations.
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An investigator and outcome assessor blinded design is chosen to reduce bias. All investigators collecting data by physical examination will be blinded to the allocation of the patients. Similarly, lab technicians performing the blood measurements will be blinded to the patient allocation. Lastly, the statistical analyses will be performed blinded to the allocation of patient groups.
|
| Usual Diet | Behavioral | Patients in the control group continue with their usual diet and/or usual dietary care. Patients in the control group will be offered access to the online platform at 24 weeks. |
|
| HbA1c and estimated change in absolute and relative CVD risk (based on change in LDL-c, SBP and HbA1c) | Per-protocol analysis | Week 12, 24 and 36 |
| Glycemic control (HOMA2-IR, HOMA2-B%, TyG-index, NAFLD Score) | Week 12 and 24 |
| Lipids and lipoprotein profile | Composition and concentration of lipoproteins and lipids, including total cholesterol, HDL-cholesterol, apolipoprotein-B, LDL-C and triglycerides | Week 12 and 24 |
| Blood pressure (systolic and diastolic) | Week 12 and 24 |
| Inflammatory profile (CRP, neutrophil and lymphocyte count) | Week 12 and 24 |
| Quality of life(EQ-5D, self-perceived stress,and DDRQOL-R(-9), medication use) | Week 12 and 24 |
| Anthropometric measurements (BMI, hip/waist ratio) | Week 12, 24 and 36 |
| Adherence (dietary index) | Week 12, 24 and 36 |
| Rate of Vitamin B12 and ferritin deficiency | Week 12 and 24 |
| Week 12 and 24 |
| Determinants of adherence | Patient characteristics | Week 12 and 24 |
| Determinants of adherence | Based on outcome of the Food Choice questionnaire | Week 12 and 24 |
| Determinants of adherence | Based on outcome of the Self-Efficacy questionnaire | Week 12 and 24 |
| Determinants of adherence | Based on outcome of the in-group identification questionnaire | Week 12 and 24 |
| Effect of the 12-week online dietary program on the CVD risk profile in the control group | Week 36 |
| Incident Hypoglycemia | Incidence of mild and severe hypoglycemia | Week 12 and 24 |
| Physical Activity (Metabolic Equivalent Tasks) | Measured using the SQUASH questionnaire | Week 12 and 24 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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