Calorie Restricted Dietary Intervention in Type 2 Diabetes Patients With Obesity for Remission
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Remission
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Contrave ER + Low-calorie Meal Box + Nutritional Intervention
Drug: Contrave ER Combination Product: Low-calorie Meal Box Behavioral: Nutritional Intervention
Intervention: Contrave ER (Drug)
Contrave ER + Low-calorie Meal Box + Nutritional Intervention
Drug: Contrave ER Combination Product: Low-calorie Meal Box Behavioral: Nutritional Intervention
Intervention: Low-calorie meal box (Combination Product)
Contrave ER + Conventional Nutritional Education
Drug: Contrave ER Behavioral: Conventional Nutritional Education
Intervention: Contrave ER (Drug)
Outcomes
Primary Outcomes
Remission
Time Frame: 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 Outcomes
- 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.)