Diabetes, Type 2, Obesity &Amp; Overweight
Conditions
Brief summary
This study aims to induce remission of type 2 diabetes through dietary intervention for weight reduction.
Detailed description
To promote weight loss, nutritionally balanced low-calorie meal boxes (provided by CJ CheilJedang) will be used. For the purpose of setting an active control group, all participants will also receive Contrave Extended-Release tablets (provided by Kwangdong Pharmaceutical), a medication indicated for weight loss.
Interventions
DRUGContrave ER
Contrave is an extended-release combination of naltrexone and bupropion, approved for chronic weight management. It acts on the central nervous system to reduce appetite and control food cravings.
COMBINATION_PRODUCTLow-calorie meal box
The meal boxes provided by CJ CheilJedang are nutritionally-balanced, low-calorie HMR products developed with reduced levels of sodium, sugar, and saturated fats.
Sponsors
Yeouido St. Mary's Hospital
HK inno.N Corporation
Handok Inc.
Kwang Dong Pharmaceutical co., ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged ≥19 and \<60 years * Confirmed diagnosis of type 2 diabetes * Diagnosed with diabetes within the past 6 years * Most recent BMI within the past 3 months ≥27 kg/m² * Most recent HbA1c within the past 3 months \<11% * No insulin therapy within the past 3 months
Exclusion criteria
* Pregnant women or those who may become pregnant during the study period * Individuals with organ failure, such as heart failure, hepatic failure, renal failure, or chronic obstructive pulmonary disease * History of cardiovascular disease or cancer treatment within the past 6 months * Acute illness requiring hospitalization (e.g., infection or surgery) within the past 3 months * Presence of endocrine disorders that may affect body weight, such as Cushing's syndrome * Use of medications (other than glucose-lowering agents for diabetes) known to affect blood glucose levels within the past 6 months * Individuals with known food allergies to specific ingredients in the study meals * Individuals with uncontrolled hypertension * Individuals with acute alcohol or drug withdrawal symptoms * History of seizure disorders such as epilepsy * Individuals with genetic disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission | From enrollment to the end of treatment at 12 weeks | The diabetes remission rate at Week 12 will be compared between the intervention and control groups relative to baseline. Remission of type 2 diabetes is defined, in accordance with the 2021 consensus report by American and European experts (Diabetes Care 2021;44:2438-44), as an HbA1c level of less than 6.5% at the end of the 12-week intervention, following discontinuation of all glucose-lowering medications at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | Assessments will be performed at baseline and week 12. For participants who consent to the extension of the study period, additional assessments will be conducted at weeks 18 and 24. | Body weight will be measured in kilograms (kg) using a calibrated scale. Changes from baseline will be evaluated. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORHyuk-Sang Kwon, MD, PhD
The Catholic University of Korea, College of Medicine
Outcome results
None listed