The Effect of an Online Plant-Based Dietary Program on Cardiovascular Risk Factors in Persons With Type 2 Diabetes Mellitus: A Randomized Controlled Trial (Plate-DM)
Diabetes Mellitus, Type 2, Diet, Vegetarian, Diet, Vegan
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion criteria Diagnosis of Type 2 Diabetes made by a physician Using oral glucose-lowering medication and/or an insulin regime with a stable dose during at least the last two months before the screening visit; Diagnosis of type 2 diabetes was made more than one year ago Age of 18 years or older on the day of signing the informed consent form. When the patients is also using lipid-lowering and/or blood pressure-lowering medication, than the dose should be stable for at least two months before the screening. Exclusion criteria Insulin-dependent type 2 diabetes in combination with hypoglycemia unawareness. Hypoglycemia unawareness is defined as the onset of hypoglycemia before the appearance of autonomic symptoms or failure to recognize hypoglycemia. Two or more episodes of severe hypoglycemia (glucose < 3 mmol/L) during the last 3 months; Uncontrolled T2D, defined as a HbA1c >86 mmol/mol (>10%); Uncontrolled hypertension, defined as an office systolic blood pressure ≥ 180mmHg; Inability to attend at least 60% of the scheduled meetings; Pregnancy or a wish to get pregnant during the study period; Diagnosis of familial hypercholesterolemia; Being diagnosed with osteoporosis. Known vitamin B12 deficiency, defined as serum vitamin B12 <130 pmol/L or using vitamin B12 supplements prescribed by a physician; Known iron deficiency defined as a serum ferritin < 25µg/L for males or < 20µg/L for females or using iron supplements prescribed by a physician;; The presence of any disease for which the patients uses a specific diet and where transitioning to a plant-based diet might lead to unfavorable effects on this disease as judged by the research team and/or the treating physician. An exception is a salt-restricted diet for hypertension; Current or planned participation in any other interventional study within 30 days of signing the informed consent form; Any medical, social or physiological circumstance which might interfere with the study, based on judgement by the principal investigator.
Sites / Locations
- Department of Vascular Medicine UMC UtrechtRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
An online 12 week plant-based dietary program
Usual Diet