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Dietary Intervention to Improve Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes (VJBD2)

Primary Purpose

Diabetes Mellitus, Type 2, Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Personalized Dietary Advice
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring dietary guidelines, dietitian, dietary fiber, diabetes type 2, nutrition, randomized controlled trial (RCT), cardiovascular diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wageningen University and ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Usual care group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Body weight (in kilograms)
As measured with a digital scale
Body mass index (kg/m^2)
Weight and height will be combined to report BMI in kg/m^2.
Waist circumference
in centimeters
Blood lipids
Total cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides
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.
Micronutrient status
Micronutrient status as measured with biomarkers in blood and (24-hour) urine samples
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.
HbA1c
As determined in blood samples
Fasting glucose
As determined in blood samples
Fasting insulin
As determined in blood samples
C-peptide
As determined in blood samples
Blood pressure
Systolic and diastolic blood pressure (mmHg) as determined with a digital blood pressure monitor
Estimated Glomerular Filtration Rate (eGFR)
in ml/min/1,73 m2 as determined from blood sample
Urinary albumin levels
in grams per deciliter (g/dL) as determined from urine sample
Liver function
Aspartate transaminase (AST) and Alanine transaminase (ALT) ratio as determined from blood sample
Inflammatory markers
hsCRP in blood samples
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.
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.
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.
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.
Sleep quality score
Sleep quality by means of Pittsburgh Sleep Quality Index (PSQI). A range of 0-21; higher scores indicate worse sleep quality.
Medical consumption
Medical consumption (incl. medication) by means of Institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ)
Productivity
Productivity by means of Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ)
Cardiovascular condition
Heart rate (bpm) 1 minute after 3-minute step test
Leg muscle strength
Measured as time to perform the 5 times sit-to-stand test (sec)
Balance score
Tandem Romberg test score, range 0-4 with higher scores indicating better balance
Flexibility
Measured as distance between finger and toes when performing the chair sit-and-reach test (cm)
Hand grip strength
Hand grip strength (kg) using a hand-held dynamometer
Skeletal muscle fat infiltration
Echo intensity of the skeletal muscle rectus femoris (ultrasound)

Full Information

First Posted
November 17, 2022
Last Updated
December 18, 2022
Sponsor
Wageningen University
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1. Study Identification

Unique Protocol Identification Number
NCT05666843
Brief Title
Dietary Intervention to Improve Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes
Acronym
VJBD2
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wageningen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Cardiovascular Diseases
Keywords
dietary guidelines, dietitian, dietary fiber, diabetes type 2, nutrition, randomized controlled trial (RCT), cardiovascular diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The nature of the intervention does not allow for blinding of the participants or researchers. After data collection, the database will be coded by an independent researcher to ensure that data analysis is conducted in a blinded way.
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Dietary Advice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiometabolic risk profile (DIAL risk score)
Description
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 Outcome Measure Information:
Title
Cardiometabolic risk profile (DIAL risk score)
Description
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
Title
Body weight (in kilograms)
Description
As measured with a digital scale
Time Frame
baseline, 6 months, 12 months
Title
Body mass index (kg/m^2)
Description
Weight and height will be combined to report BMI in kg/m^2.
Time Frame
baseline, 6 months, 12 months
Title
Waist circumference
Description
in centimeters
Time Frame
baseline, 6 months, 12 months
Title
Blood lipids
Description
Total cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides
Time Frame
baseline, 6 months, 12 months
Title
Dietary intake
Description
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
Title
Micronutrient status
Description
Micronutrient status as measured with biomarkers in blood and (24-hour) urine samples
Time Frame
baseline, 6 months, 12 months
Title
Food literacy
Description
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
Title
HbA1c
Description
As determined in blood samples
Time Frame
baseline, 6 months, 12 month
Title
Fasting glucose
Description
As determined in blood samples
Time Frame
baseline, 6 months, 12 month
Title
Fasting insulin
Description
As determined in blood samples
Time Frame
baseline, 6 months, 12 month
Title
C-peptide
Description
As determined in blood samples
Time Frame
baseline, 6 months, 12 month
Title
Blood pressure
Description
Systolic and diastolic blood pressure (mmHg) as determined with a digital blood pressure monitor
Time Frame
baseline, 6 months, 12 months
Title
Estimated Glomerular Filtration Rate (eGFR)
Description
in ml/min/1,73 m2 as determined from blood sample
Time Frame
baseline, 6 months, 12 months
Title
Urinary albumin levels
Description
in grams per deciliter (g/dL) as determined from urine sample
Time Frame
baseline, 6 months, 12 months
Title
Liver function
Description
Aspartate transaminase (AST) and Alanine transaminase (ALT) ratio as determined from blood sample
Time Frame
baseline, 6 months, 12 months
Title
Inflammatory markers
Description
hsCRP in blood samples
Time Frame
baseline, 6 months, 12 months
Title
Quality of life score
Description
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
Title
Health index score
Description
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
Title
Positive health score
Description
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
Title
Self efficacy score
Description
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
Title
Sleep quality score
Description
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
Title
Medical consumption
Description
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
Title
Productivity
Description
Productivity by means of Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ)
Time Frame
baseline, 3 months, 6 months, 12 months
Title
Cardiovascular condition
Description
Heart rate (bpm) 1 minute after 3-minute step test
Time Frame
baseline, 6 months, 12 months
Title
Leg muscle strength
Description
Measured as time to perform the 5 times sit-to-stand test (sec)
Time Frame
baseline, 6 months, 12 months
Title
Balance score
Description
Tandem Romberg test score, range 0-4 with higher scores indicating better balance
Time Frame
baseline, 6 months, 12 months
Title
Flexibility
Description
Measured as distance between finger and toes when performing the chair sit-and-reach test (cm)
Time Frame
baseline, 6 months, 12 months
Title
Hand grip strength
Description
Hand grip strength (kg) using a hand-held dynamometer
Time Frame
baseline, 6 months, 12 months
Title
Skeletal muscle fat infiltration
Description
Echo intensity of the skeletal muscle rectus femoris (ultrasound)
Time Frame
baseline, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johanna M Geleijnse, Professor
Phone
0031317482574
Email
marianne.geleijnse@wur.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Iris van Damme, MSc
Email
iris.vandamme@wur.nl
Facility Information:
Facility Name
Wageningen University and Research
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6708WE
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iris van Damme, MSc
Phone
0031317486957
Email
iris.vandamme@wur.nl

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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