Primary Objective:• To evaluate the effect of an online 12 week plant-based dietary program compared to usual diet on change in glycated hemoglobin and estimated relative CVD risk in persons with type 2 diabetes. Secondary Objective(s): • To…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Lipid metabolism disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
References are indicated with a number. The relevant source can be found in the
reference list of the protocol
Persons with Type 2 Diabetes (T2D) are at an increased risk of cardiovascular
disease (CVD) and mortality1. Dietary changes are recommended by guidelines to
treat T2D and reduce risk of CVD2-4. Plant-based diets eliminate certain (i.e.
vegetarian diet) or eliminate all animal based products (i.e. vegan diet)5.
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%]6 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-bias7. Furthermore, plant-based diets might reduce blood
pressure (BP). However, while vegetarian diets reduce BP in patients with and
without hypertension8, 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
related9 to CVD risk in persons with T2D10,11, 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 meetings12-14 and cooking sessions13. 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
reported15.
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.
Study objective
Primary Objective:
• To evaluate the effect of an online 12 week plant-based dietary program
compared to usual diet on change in glycated hemoglobin and estimated relative
CVD risk in persons with type 2 diabetes.
Secondary Objective(s):
• To evaluate the effect of an online 12 week plant-based dietary program
compared to usual diet in persons with type 2 diabetes on
o estimated absolute CVD risk reduction;
o glycemic control, lipid profile, blood pressure and inflammation;
o medication use, quality of life and stress in persons;
o incidence of hypoglycemia or other adverse events;
o body weight, BMI and waist circumference.
• To evaluate to which extent the effect of an online 12 week online
plant-based dietary program on glycemic control, lipid profile, chronic
inflammation and blood pressure is modified by
o adherence to the plant-based diet.;
o T2D subtype;
o change in body weight.
• To evaluate the effect of an online 12 week plant-based dietary platform
without arranged support groups in the control group on estimated relative CVD
risk reduction in persons with type 2 diabetes.
• To identify barriers to and factors supporting adherence to a plant-based
diet in patient with type 2 diabetes.
• To identify the effect of providing access to an online learning environment
(without support groups and with self-arranged care from a dietician) on
glycemic control, lipid profile, blood pressure and medication usage in persons
with type 2 diabetes.
Study design
a single center, randomized, investigator blinded, parallel, 12-week controlled
trial. One group will receive the online plant-based dietary program, the other
group will receive (dietary) care as usual. The trials starts with a one week
run-in period, after which baseline measures are collected. The measurements of
primary end-point are collected in week 12 and additional follow-up
measurements are collected in week 24.
Intervention
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 products while reducing their of animal
products as much as possible. The control group will be offered access to the
online platform at the end of the study.
Study burden and risks
The hypothesized beneficial insulin sensitizing effect of the dietary
intervention may increase the risk of occurrence of mild hypoglycemia and may
lead to a reduced need of glucose-lowering drugs and insulin13,14,16-21. In the
present trial multiple measures have been taken to ensure that patients receive
standard of care during the trial (see section 5.2). Thus, while some episodes
of mild hypoglycemia may occur, given the measures in place, the risk of severe
hypoglycemia is deemed small. Another potential risk of a strictly plant based
diet are deficiencies in vitamin B12. For this reason, patients in the
intervention group will take a vitamin B12 supplement. The burden for patients
consists of 4 visits to the hospital for measurements for the intervention
group and 5 for the control group. During the visits, patients need to be
fasted, will have their blood drawn and a physical exam will be performed.
Patients will also fill-out seven questionnaires and a dietary record. The
burden of the intervention made up of the online program, sessions with the
dietician and the group sessions. Completing all sessions is expected to take
about 40 hours.
Expected benefits of the intervention for patients are weight loss, improved
glycemic control and improved cardiovascular risk profile. Whether these
effects last, is probably largely dependent on long term adherence
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCTnummervolgt |
| CCMO | NL80378.041.22 |