Dietary Intervention to Improve Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial to examine whether personalized guidance to increase the consumption of fiber rich food items according to the Dutch dietary guidelines, compared to usual care, improves health of individuals with type 2 diabetes.

Detailed Description
-----------------
Previous interventions with fibre supplements show promising results among individuals with type 2 diabetes, but wether these effects are similar when higher fiber intake is achieved through diet and not through supplements remains unclear. The primary objective of this study is to investigate the effects of personalized dietary guidance to increase the intake of fibre-rich foods, as recommended in the Dutch dietary guidelines, on cardiometabolic risk profile in individuals who have type 2 diabetes, compared to usual care after six months. The study is a parallel randomized trial over a period of twelve months, including an intervention period of six months and a follow up period of six months. The study population consists of adults with non-insulin-dependent type 2 diabetes, diagnosed by a medical doctor at least 6 months prior to study enrolment.

Official Title
-----------------
The Effects of Personalized Dietary Guidance to Increase the Intake of Fibre-rich Foods on Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes. (in Dutch: Voed je Beter Met Diabetes Type 2)

Conditions
-----------------
Diabetes Mellitus, Type 2, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Behavioral: Personalized Dietary Advice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of type 2 diabetes made by a medical doctor at least 6 months prior to study enrolment Adult Willing and able to follow dietary intervention Willing to participate in both intervention and control group Living at a reasonable distance from the research center at Wageningen University & Research (WUR) (i.e.maximum of ± 1 hour away) Exclusion Criteria: Currently treated with insulin therapy Recently (< 6 months) or currently being under supervision of a dietician Pregnant or breast-feeding History of bariatric surgery, including gastric banding Current participation in a study with an investigational drug or dietary intervention Excessive alcohol consumption (more than 14 units for males/7 units for females per week) or drug use Clinical disorders that could interfere with the intervention (e.g. gastro-intestinal disorders, auto-immune diseases, psychiatric disorders, uncontrolled heart diseases, serious neurological disorders, renal failure or cancer) Not able to speak and understand the Dutch language No general practitioner Working at the department of Human Nutrition and Health at Wageningen University & Research

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Personalized dietary guidance to increase the intake of fibre-rich foods on top of usual care. The dietary guidance is implemented by dieticians and is personalized based on current adherence to the dietary guidelines, usual dietary intake, gender and personal goals and preferences. | Behavioral: Personalized Dietary Advice<br>* Personalized dietary guidance to increase the intake of fibre-rich foods on top of usual care.The dietary guidance is implemented by dieticians and is personalized based on current adherence to the dietary guidelines, usual dietary intake, gender and personal goals and preferences.<br>|
| No Intervention: Usual care group<br>Participants in the control group receive usual health care as provided by general practitioners and nurse practitioners or other health care professionals involved in diabetes care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiometabolic risk profile (DIAL risk score) | The change in cardiovascular risk based on observed changes in HbA1c, LDL-cholesterol and systolic blood pressure. DIAL risk score ranges from 0 to 100%, with higher scores indicating a higher risk. | Change from baseline at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiometabolic risk profile (DIAL risk score) | The change in cardiovascular risk based on observed changes in HbA1c, LDL-cholesterol and systolic blood pressure. DIAL risk score ranges from 0 to 100%, with higher scores indicating a higher risk. | Change from baseline at 12 months | 
| Body weight (in kilograms) | As measured with a digital scale | baseline, 6 months, 12 months | 
| Body mass index (kg/m^2) | Weight and height will be combined to report BMI in kg/m^2. | baseline, 6 months, 12 months | 
| Waist circumference | in centimeters | baseline, 6 months, 12 months | 
| Blood lipids | Total cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides | baseline, 6 months, 12 months | 
| Dietary intake | Nutrient intake and diet quality score for the level of adherence to the Dutch dietary guidelines. Diet quality score (Dutch Healthy Diet index) ranges from 0-160, with higher scores indicating better diet quality. | baseline, 3 months, 6 months, 12 months | 
| Micronutrient status | Micronutrient status as measured with biomarkers in blood and (24-hour) urine samples | baseline, 6 months, 12 months | 
| Food literacy | Food literacy level by means of the 29-item Self Perceived Food Literacy Scale (SPFL-29). Scores range from 29-145, with higher scores indicating a higher level food literacy. | baseline, 3 months, 6 months, 12 months | 
| HbA1c | As determined in blood samples | baseline, 6 months, 12 month | 
| Fasting glucose | As determined in blood samples | baseline, 6 months, 12 month | 
| Fasting insulin | As determined in blood samples | baseline, 6 months, 12 month | 
| C-peptide | As determined in blood samples | baseline, 6 months, 12 month | 
| Blood pressure | Systolic and diastolic blood pressure (mmHg) as determined with a digital blood pressure monitor | baseline, 6 months, 12 months | 
| Estimated Glomerular Filtration Rate (eGFR) | in ml/min/1,73 m2 as determined from blood sample | baseline, 6 months, 12 months | 
| Urinary albumin levels | in grams per deciliter (g/dL) as determined from urine sample | baseline, 6 months, 12 months | 
| Liver function | Aspartate transaminase (AST) and Alanine transaminase (ALT) ratio as determined from blood sample | baseline, 6 months, 12 months | 
| Inflammatory markers | hsCRP in blood samples | baseline, 6 months, 12 months | 
| Quality of life score | Health related quality of life assessed with the 36-Item Short Form Survey (SF-36). Scores range from 0-100, with higher scores indicating higher quality of life. | baseline, 3 months, 6 months, 12 months | 
| Health index score | 5-level EuroQol-5D version (EQ-5D). The maximum score of 1 indicates the best health state. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health status. | baseline, 3 months, 6 months, 12 months | 
| Positive health score | Positive health is assessed with the 17-item Positive Health measurement scale. scores range from 0-170 with higher scores indicating higher positive health. | baseline, 3 months, 6 months, 12 months | 
| Self efficacy score | Self-efficacy as assessed with the Dutch General Self-Efficacy scale (DGSES). The total score ranges between 10 and 40, with a higher score indicating more self-efficacy. | baseline, 3 months, 6 months, 12 months | 
| Sleep quality score | Sleep quality by means of Pittsburgh Sleep Quality Index (PSQI). A range of 0-21; higher scores indicate worse sleep quality. | baseline, 3 months, 6 months, 12 months | 
| Medical consumption | Medical consumption (incl. medication) by means of Institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ) | baseline, 3 months, 6 months, 12 months | 
| Productivity | Productivity by means of Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ) | baseline, 3 months, 6 months, 12 months | 
| Cardiovascular condition | Heart rate (bpm) 1 minute after 3-minute step test | baseline, 6 months, 12 months | 
| Leg muscle strength | Measured as time to perform the 5 times sit-to-stand test (sec) | baseline, 6 months, 12 months | 
| Balance score | Tandem Romberg test score, range 0-4 with higher scores indicating better balance | baseline, 6 months, 12 months | 
| Flexibility | Measured as distance between finger and toes when performing the chair sit-and-reach test (cm) | baseline, 6 months, 12 months | 
| Hand grip strength | Hand grip strength (kg) using a hand-held dynamometer | baseline, 6 months, 12 months | 
| Skeletal muscle fat infiltration | Echo intensity of the skeletal muscle rectus femoris (ultrasound) | baseline, 6 months, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dietary guidelines, dietitian, dietary fiber, diabetes type 2, nutrition, randomized controlled trial (RCT), cardiovascular diseases