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

Diabetes Mellitus, Type 2 Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05666843
• Other study ID #: NL80697.091.22
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 124
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Personalized Dietary Advice
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.

Locations

Country	Name	City	State
Netherlands	Wageningen University and Research	Wageningen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Body weight (in kilograms)	As measured with a digital scale	baseline, 6 months, 12 months
Secondary	Body mass index (kg/m^2)	Weight and height will be combined to report BMI in kg/m^2.	baseline, 6 months, 12 months
Secondary	Waist circumference	in centimeters	baseline, 6 months, 12 months
Secondary	Blood lipids	Total cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides	baseline, 6 months, 12 months
Secondary	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
Secondary	Micronutrient status	Micronutrient status as measured with biomarkers in blood and (24-hour) urine samples	baseline, 6 months, 12 months
Secondary	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
Secondary	HbA1c	As determined in blood samples	baseline, 6 months, 12 month
Secondary	Fasting glucose	As determined in blood samples	baseline, 6 months, 12 month
Secondary	Fasting insulin	As determined in blood samples	baseline, 6 months, 12 month
Secondary	C-peptide	As determined in blood samples	baseline, 6 months, 12 month
Secondary	Blood pressure	Systolic and diastolic blood pressure (mmHg) as determined with a digital blood pressure monitor	baseline, 6 months, 12 months
Secondary	Estimated Glomerular Filtration Rate (eGFR)	in ml/min/1,73 m2 as determined from blood sample	baseline, 6 months, 12 months
Secondary	Urinary albumin levels	in grams per deciliter (g/dL) as determined from urine sample	baseline, 6 months, 12 months
Secondary	Liver function	Aspartate transaminase (AST) and Alanine transaminase (ALT) ratio as determined from blood sample	baseline, 6 months, 12 months
Secondary	Inflammatory markers	hsCRP in blood samples	baseline, 6 months, 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Productivity	Productivity by means of Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ)	baseline, 3 months, 6 months, 12 months
Secondary	Cardiovascular condition	Heart rate (bpm) 1 minute after 3-minute step test	baseline, 6 months, 12 months
Secondary	Leg muscle strength	Measured as time to perform the 5 times sit-to-stand test (sec)	baseline, 6 months, 12 months
Secondary	Balance score	Tandem Romberg test score, range 0-4 with higher scores indicating better balance	baseline, 6 months, 12 months
Secondary	Flexibility	Measured as distance between finger and toes when performing the chair sit-and-reach test (cm)	baseline, 6 months, 12 months
Secondary	Hand grip strength	Hand grip strength (kg) using a hand-held dynamometer	baseline, 6 months, 12 months
Secondary	Skeletal muscle fat infiltration	Echo intensity of the skeletal muscle rectus femoris (ultrasound)	baseline, 6 months, 12 months