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Completed

NCT Number: NCT07753447

Calorie Restricted Dietary Intervention in Type 2 Diabetes Patients With Obesity for Remission

This study aims to induce remission of type 2 diabetes through dietary intervention for weight reduction.

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Key information

Conditions

Diabetes, Type 2 Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity &Amp; Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yeouido Saint Mary's Hospital

Seoul, 07345, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contrave ER

Drug

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.

Low-calorie meal box

Combination Product

The meal boxes provided by CJ CheilJedang are nutritionally-balanced, low-calorie HMR products developed with reduced levels of sodium, sugar, and saturated fats.

Primary outcomes

  1. 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

  1. Body weight

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yeouido St. Mary's Hospital

Other

Collaborators

  • HK inno.N Corporation
  • Handok Inc.
  • Kwang Dong Pharmaceutical co., ltd.

Registry information

Acronym: K-Direct2

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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