Clinical trial NCT06985095: Evaluation of a Structured Nutrition Educational Program in Insulin-treated Diabetic Patients in Vietnam
Official title: Effectiveness of a Structured Nutrition Educational Program on Glycemic Control, Quality of Life, and Cardiovascular Risk in Patients With Uncontrolled Diabetes Using Multiple Daily Insulin Injections
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Keywords: nutrition educational program
diabetes
multiple daily injection insulin users
Lead sponsor: Cho Ray Hospital
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if learning about healthy eating can help people with diabetes control their blood sugar better.

This study is for men and women between 18 and 70 years old who use insulin at least twice a day but still have high blood sugar.

We want to answer the following questions:

Can nutrition education help lower HbA1c (a blood test that shows average blood sugar over the past 3 months)? Can it improve knowledge about nutrition, quality of life, and make blood sugar more stable? Will it help reduce fasting blood sugar, lipid levels, body weight, and the number of times low blood sugar (hypoglycemia) happens?

Participants will be divided into two groups:

One group will receive a nutrition booklet. The other group will receive the same booklet and join four monthly lessons with a researcher.

The four lessons will talk about:

Goals for managing diabetes Main nutrients in food How to plan meals How to eat in a way that supports better blood sugar control

Detailed description: This study will involve 115 people with diabetes who need to take insulin at least twice a day. It includes those who already use multiple insulin injections but still have high blood sugar, and those who are newly switched to at least two insulin shots daily because their blood sugar is not well controlled with pills or pills plus one injection.

The study will take place at Cho Ray Hospital in Ho Chi Minh City, Vietnam, and will run from 2025 to the end of 2026. People will be invited to join at the Endocrinology Consultation Unit. If they agree, their phone number will be collected and the research team will call them later to explain more about the study. If they are still interested, they'll be asked to keep a food diary for three days before their screening.

On the screening day, they'll sign a short consent form, get blood tests to check their sugar, HbA1c, cholesterol, and kidney function, talk with a nutrition researcher about their food diary, and have a usual consultation with their doctor. If they meet all the criteria and agree to take part, they'll sign the full consent form and take short tests on nutrition knowledge and quality of life. The quality of life questionnaire used is the SF-36 questionnaire, and nutrition knowledge is assessed using the Diabetes-related Nutrition Knowledge Questionnaire (DRNK-Q).

After that, they will be randomly assigned to one of two groups. One group will get a nutrition booklet only. The other group will receive the booklet plus attend four monthly sessions with a researcher to learn about healthy eating for diabetes. In each group, 10 participants will also wear a flash glucose monitor (a small device that checks sugar levels without finger pricks) three times: at the beginning, after 3 months, and after 6 months. These participants will be selected based on age, HbA1c level, ability to use the device, and whether they often experience low blood sugar.

During the 6-month study period, all participants will have blood tests every 3 months to check HbA1c, fasting sugar, and lipid; they will be asked monthly about any low blood sugar episodes; they will repeat the nutrition and quality of life tests at 6 months; their weight and waist size will be measured every 3 months, and their height will be measured at the start of the study

Eligibility criteria: Inclusion Criteria:

* People between 18 and 70 years old.
* People who come to Cho Ray Hospital for diabetes care and plan to keep getting care there for at least six months.
* People who have diabetes and have been prescribed diabetes medicine.
* People who were recently diagnosed with diabetes, based on the latest guidelines from the American Diabetes Association.
* People whose blood sugar (HbA1c) level is higher than 8%.
* People who are currently using at least two insulin injections a day or have just started a daily multiple insulin injection plan because their diabetes is not well controlled.

Exclusion Criteria:

* People who are seriously ill and need to stay in the hospital, such as those with infections, pneumonia, heart attacks, strokes, or infected diabetic foot.
* People who have cancer, serious mental health problems, or problems with drug use.
* People who do not want to take part or cannot follow the study plan.

Primary outcomes:
measure: the difference in the change of HbA1c between the two groups after six months of follow-up
timeFrame: For enrollment to the end of study at 6 months
Secondary outcomes:
measure: The changes in quality of life after six months of follow-up within and between groups
timeFrame: From enrollment to the end of study at 6 months
measure: The change in nutrition knowlege at the start of the study and after 6 months between two groups
timeFrame: From enrollment to the end of study at 6 months.
measure: The changes in BMI (Body mass index) after six months of follow-up within and between groups
timeFrame: From enrollment to the end of treatment at 6 months
measure: The changes in Waist Circumference after six months of follow-up within and between groups
timeFrame: From enrollment to the end of treatment at 6 months
measure: The changes in plasma LDL cholesterol (bad cholesterol) after six months of follow-up within and between groups
timeFrame: From enrollment to the end of treatment at 6 months
measure: The changes in plasma total cholesterol after six months of follow-up within and between groups
timeFrame: From enrollment to the end of treatment at 6 months
measure: The changes in plasma triglycerides after six months of follow-up within and between groups
timeFrame: From enrollment to the end of treatment at 6 months
measure: The changes in plasma HDL cholesterol (good cholesterol) after six months of follow-up within and between groups
timeFrame: From enrollment to the end of treatment at 6 months
Other outcomes:
measure: The change in total daily insulin dose before and after the intervention between groups
timeFrame: From enrollment to the end of study at six months
measure: The change in time in range over six months between groups: standard group and nutrition intervention group
timeFrame: From enrollment to the end of study at six months
measure: The change in the number of insulin injections per day before and after the intervention between groups
timeFrame: From enrollment to the end of treatment at 6 months
measure: The change in the number of anti-diabetic oral medications before and after the intervention between groups
timeFrame: From enrollment to the end of treatment at 6 months
measure: The change in time in hyperglycemia over six months between groups: standard group and nutrition intervention group
timeFrame: From enrollment to the end of treatment at 6 months
measure: The change in time in hypoglycemia over six months between groups: standard group and nutrition intervention group
timeFrame: From enrollment to the end of treatment at 6 months
Locations:
city: Ho Chi Minh
country: Vietnam
facility: Cho Ray Hospital
Study officials:
affiliation: Cho Ray Hospital
name: Na Ly Dau, MD
role: PRINCIPAL_INVESTIGATOR
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