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

Wageningen University124 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

124

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases

Interventions

Personalized Dietary AdviceBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Wageningen University and Research

Wageningen, Gelderland, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: Change from baseline at 6 months

Secondary Outcomes

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.

Time frame: Change from baseline at 12 months

Body weight (in kilograms)

As measured with a digital scale

Time frame: baseline, 6 months, 12 months

Body mass index (kg/m^2)

Weight and height will be combined to report BMI in kg/m\^2.

Time frame: baseline, 6 months, 12 months

Waist circumference

in centimeters

Time frame: baseline, 6 months, 12 months

Blood lipids

Total cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides

Time frame: 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.

Time frame: baseline, 3 months, 6 months, 12 months

Data from ClinicalTrials.gov

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Micronutrient status

Micronutrient status as measured with biomarkers in blood and (24-hour) urine samples

Time frame: 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.

Time frame: baseline, 3 months, 6 months, 12 months

HbA1c

As determined in blood samples

Time frame: baseline, 6 months, 12 month

Fasting glucose

As determined in blood samples

Time frame: baseline, 6 months, 12 month

Fasting insulin

As determined in blood samples

Time frame: baseline, 6 months, 12 month

C-peptide

As determined in blood samples

Time frame: baseline, 6 months, 12 month

Blood pressure

Systolic and diastolic blood pressure (mmHg) as determined with a digital blood pressure monitor

Time frame: baseline, 6 months, 12 months

Estimated Glomerular Filtration Rate (eGFR)

in ml/min/1,73 m2 as determined from blood sample

Time frame: baseline, 6 months, 12 months

Urinary albumin levels

in grams per deciliter (g/dL) as determined from urine sample

Time frame: baseline, 6 months, 12 months

Liver function

Aspartate transaminase (AST) and Alanine transaminase (ALT) ratio as determined from blood sample

Time frame: baseline, 6 months, 12 months

Inflammatory markers

hsCRP in blood samples

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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)

Time frame: baseline, 3 months, 6 months, 12 months

Productivity

Productivity by means of Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ)

Time frame: baseline, 3 months, 6 months, 12 months

Cardiovascular condition

Heart rate (bpm) 1 minute after 3-minute step test

Time frame: baseline, 6 months, 12 months

Leg muscle strength

Measured as time to perform the 5 times sit-to-stand test (sec)

Time frame: baseline, 6 months, 12 months

Balance score

Tandem Romberg test score, range 0-4 with higher scores indicating better balance

Time frame: baseline, 6 months, 12 months

Flexibility

Measured as distance between finger and toes when performing the chair sit-and-reach test (cm)

Time frame: baseline, 6 months, 12 months

Hand grip strength

Hand grip strength (kg) using a hand-held dynamometer

Time frame: baseline, 6 months, 12 months

Skeletal muscle fat infiltration

Echo intensity of the skeletal muscle rectus femoris (ultrasound)

Time frame: baseline, 6 months, 12 months