Type 2 DiabetesK-Direct1NCT05754775
Remission of Type 2 Diabetes Via Calorie Restriction
A study testing Calorie restriction via total food replacement in people with Type 2 Diabetes and Obesity, Morbid, run by Yeouido St. Mary's Hospital at 1 site in South Korea.
Trial summary
The primary purpose was to evaluate the efficacy of Korean low-calorie diet for obese adult patients with type 2 diabetes with a body mass index of 25 kg/m2 or higher. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes, Obesity, Morbid
- What is being tested?
- Calorie restriction via total food replacement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 2 diabetes
- If you have been diagnosed with diabetes within the last 6 years and have been treated for diabetes for more than 3 months
- Glycated hemoglobin was measured as less than 9% without insulin treatment for the last 3 months
- Body mass index of 23kg/m2 or more
Who cannot join
- Pregnant women
- Target organ failure such as heart failure, liver failure, kidney failure, and chronic obstructive disease
- History of cardiovascular disease and cancer and current treatment
- Acute infection or acute treatment requiring hospitalization such as surgery within the last 3 months
- Any medications that may affect blood sugar within the last 6 months
- Food allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Type 2 Diabetes Remission Induced by a Korean Low-calorie Diet: A Single Center Pilot Study
The primary purpose was to evaluate the efficacy of Korean low-calorie diet for obese adult patients with type 2 diabetes with a body mass index of 25 kg/m2 or higher.
Read the detailed description
Previous studies reporting the natural course of type 2 diabetes generally reported progressive worsening of the disease. However, several recent studies suggested that significant weight loss induced by an very-low calorie diet could lead to the improvement in glycemic control that enough to drug discontinuation. Considering that improvement in diabetes is not permanent and hyperglycemia may recur, American and European expert groups define and express the improvement of diabetes as "remission".
In several studies in the Western contries, remission was confimed in patients who achieved significant weight loss with a daily intake of less than 800 kcal consisting of powder with high protein ingredients. When 11 patients with the disease were given only 600 kcal daily for 8 weeks, fasting blood glucose significantly decreased within 7 days. (Diabetologia 2011; 54: 2506-14). In a follow-up study, dietary intervention for 8 weeks was applied to 30 patients, about 40% of the patients showed remission of diabetes. (Diabetes Care 2016; 39: 158-65).
Based on this small study, a primary care-based research group in the United Kingdom recruited obese diabetic patients from private clinics across the country and evaluated the diabetic remission effect of a very-low caloric diet in a total of 306 patients. In this study, 46% of the intervention group and 4% of the non-intervention group reported remission, confirming a significant difference in remission rates. Patients who achieved more weight loss in the intervention group had higher remission rates, with a remission rate of 57% for patients who lost 10 to 15 kg and a remission rate of 86% for patients who lost more than 15 kg. (Lancet 2018; 391: 541-51).
On the other hand, in Korea, a study has been conducted using a Korean traditional foods designed by clinical nutritionists for diabetic patients that delivers to home. When continuous blood glucose measurement was performed while the special diet program was provided for 2 weeks, mean blood glucose and estimated glycated hemoglobin during the treatment diet period decreased compared to the free food period. The effect of the Korean-style diabetic diet was thought to be mainly due to the decrease in blood glucose levels after meals (J Korean Diabetes 2020;21:46-54).
In previous studies, total food replacement for calorie restriction was only attempted in the form of powder. In the case of the Korean diet, it contains a sufficient amount of dietary fiber and has the advantage of maintaining appropriate clinical nutrition therapy by providing various textures and tastes. Therefore, the investigators planned a clinical study to induce remission with a low-calorie diet using the Korean diet as a meal replacement therapy for calorie restriction in Korean patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes, Obesity, Morbid
- Being tested
- Calorie restriction via total food replacement
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calorie restriction via total food replacementBehavioural
Restricted foods designed by a clinical nutritionist that delivers to home for diabetic patients.
| Study group | Role | What they receive |
|---|---|---|
| Low-calorie diet | Experimental | Korean low-calorie diet for type 2 diabetes Receives: Behavioral: Calorie restriction via total food replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission
It is defined as a case where the HbA1c measured at the end of the 12-week intervention after stopping the drug was less than 6.5%.
Measured: The glycated hemoglobin level in percentage measured 12 weeks after the study screening date was used.
Secondary outcomes (1)
Weight loss
It is defined as the change in body weight before and after the intervention.
Measured: The body weight in kilograms measured 12 weeks after the study screening date was used.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Jun 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeouido St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Hyuk-Sang Kwon, Principal investigator, Yeouido St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754775
- Sponsor's protocol ID
- SC23ENSE0036
- Other IDs
- 2021R1A2C2013890
- Acronym
- K-Direct1
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2023
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 Diabetes Remission Induced by a Korean Low-calorie Diet: A Single Center Pilot Study
- ClinicalTrials.gov ID
- NCT05754775
- Acronym / sponsor ID
- K-Direct1 / SC23ENSE0036
- Conditions
- Type 2 Diabetes, Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Yeouido St. Mary's HospitalUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose was to evaluate the efficacy of Korean low-calorie diet for obese adult patients with type 2 diabetes with a body mass index of 25 kg/m2 or higher.
Detailed description
Previous studies reporting the natural course of type 2 diabetes generally reported progressive worsening of the disease. However, several recent studies suggested that significant weight loss induced by an very-low calorie diet could lead to the improvement in glycemic control that enough to drug discontinuation. Considering that improvement in diabetes is not permanent and hyperglycemia may recur, American and European expert groups define and express the improvement of diabetes as "remission".
In several studies in the Western contries, remission was confimed in patients who achieved significant weight loss with a daily intake of less than 800 kcal consisting of powder with high protein ingredients. When 11 patients with the disease were given only 600 kcal daily for 8 weeks, fasting blood glucose significantly decreased within 7 days. (Diabetologia 2011; 54: 2506-14). In a follow-up study, dietary intervention for 8 weeks was applied to 30 patients, about 40% of the patients showed remission of diabetes. (Diabetes Care 2016; 39: 158-65).
Based on this small study, a primary care-based research group in the United Kingdom recruited obese diabetic patients from private clinics across the country and evaluated the diabetic remission effect of a very-low caloric diet in a total of 306 patients. In this study, 46% of the intervention group and 4% of the non-intervention group reported remission, confirming a significant difference in remission rates. Patients who achieved more weight loss in the intervention group had higher remission rates, with a remission rate of 57% for patients who lost 10 to 15 kg and a remission rate of 86% for patients who lost more than 15 kg. (Lancet 2018; 391: 541-51).
On the other hand, in Korea, a study has been conducted using a Korean traditional foods designed by clinical nutritionists for diabetic patients that delivers to home. When continuous blood glucose measurement was performed while the special diet program was provided for 2 weeks, mean blood glucose and estimated glycated hemoglobin during the treatment diet period decreased compared to the free food period. The effect of the Korean-style diabetic diet was thought to be mainly due to the decrease in blood glucose levels after meals (J Korean Diabetes 2020;21:46-54).
In previous studies, total food replacement for calorie restriction was only attempted in the form of powder. In the case of the Korean diet, it contains a sufficient amount of dietary fiber and has the advantage of maintaining appropriate clinical nutrition therapy by providing various textures and tastes. Therefore, the investigators planned a clinical study to induce remission with a low-calorie diet using the Korean diet as a meal replacement therapy for calorie restriction in Korean patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-calorie diet | Experimental | Behavioral: Calorie restriction via total food replacementKorean low-calorie diet for type 2 diabetes |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Type 2 diabetes
- Body mass index of 23kg/m2 or more
Key exclusion criteria (6 listed)
- Pregnant women
- Target organ failure such as heart failure, liver failure, kidney failure, and chronic obstructive disease
- History of cardiovascular disease and cancer and current treatment
- Acute infection or acute treatment requiring hospitalization such as surgery within the last 3 months
- Any medications that may affect blood sugar within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calorie restriction via total food replacementRestricted foods designed by a clinical nutritionist that delivers to home for diabetic patients. | Behavioural | Low-calorie diet |
Primary outcome
Remission
Time frame: The glycated hemoglobin level in percentage measured 12 weeks after the study screening date was used.
It is defined as a case where the HbA1c measured at the end of the 12-week intervention after stopping the drug was less than 6.5%.
1 secondary outcome
Weight loss
Time frame: The body weight in kilograms measured 12 weeks after the study screening date was used.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyuk-Sang Kwon principal investigator
Yeouido St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calorie restriction via total food replacement in people with Type 2 Diabetes and Obesity, Morbid, run by Yeouido St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission (time frame: The glycated hemoglobin level in percentage measured 12 weeks after the study screening date was used.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.