diabetes diabetes mellitus
Conditions
Interventions
a 12-week plant-based dietary program consisting of information via an online
platform, guidance by dieticians and peer support groups. Patients will aim to
maximize their intake of plant-based prod
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of Type 2 Diabetes sinds at least 1 year and using oral glucose-lowering medication 2. If using lipid-lowering and/or blood pressure-lowering medication than on a stable dose for at least 2 months before the screening. 3. Age of 18 years or older on the day of signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Hypoglycemia unawareness 2. 2 or more episodes of severe hypoglycemia during last 3 months 3. uncontrolled hypertension or diabetes 4. vitamin B12 or iron deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A blinded intention-to-treat analysis of the endpoint will be conducted. The primary outcomes of this study are change in HbA1c and change in estimated relative CVD risk (based on change in LDL-c, SBP and HbA1c) after 12 weeks of intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes of will be measures of glycemic control (HOMA2-IR, HOMA2-B%, TyG-index, NAFLD Score), lipoprotein profile (LDL cholesterol, apolipoprotein B, non-HDL cholesterol, HDL cholesterol), inflammation, blood pressure, quality of life, anthropometric measurements (BMI, hip/waist ratio) and adherence to the dietary intervention will be assessed using a dietary index. Lastly, the effect of the adherence and diabetes subtype (e.g. insulin-resistant or insulin deficient) on these outcomes will be quantified and barriers and factors supporting adherence will be identified. | — |
Countries
Netherlands
Outcome results
None listed