The Effect of an Online Plant-Based Dietary Program on Cardiovascular Risk Factors in Persons with Type 2 Diabetes Mellitus: A Randomized Controlled Trial

Recruiting

Conditions: 10018424
10013317
diabetes
diabetes mellitus
10003216

Registration Number: NL-OMON51514

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 140

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A blinded intention-to-treat analysis of the endpoint will be conducted. The<br /><br>primary outcomes of this study are change in HbA1c and change in estimated<br /><br>relative CVD risk (based on change in LDL-c, SBP and HbA1c) after 12 weeks of<br /><br>intervention. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes of will be measures of glycemic control (HOMA2-IR, HOMA2-B%,<br /><br>TyG-index, NAFLD Score), lipoprotein profile (LDL cholesterol, apolipoprotein<br /><br>B, non-HDL cholesterol, HDL cholesterol), inflammation, blood pressure, quality<br /><br>of life, anthropometric measurements (BMI, hip/waist ratio) and adherence to<br /><br>the dietary intervention will be assessed using a dietary index. Lastly, the<br /><br>effect of the adherence and diabetes subtype (e.g. insulin-resistant or insulin<br /><br>deficient) on these outcomes will be quantified and barriers and factors<br /><br>supporting adherence will be identified. </p><br>