Remission of Type 2 Diabetes Via Calorie Restriction

NCT05754775 | Completed DMC

• 2 other identifiers: SC23ENSE00362021R1A2C2013890
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

• 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%.

  The glycated hemoglobin level in percentage measured 12 weeks after the study screening date was used.

Secondary Outcomes (1)

• Weight loss

  The body weight in kilograms measured 12 weeks after the study screening date was used.

Study Arms (1)

Low-calorie diet

EXPERIMENTAL

Korean low-calorie diet for type 2 diabetes

Behavioral: Calorie restriction via total food replacement

Interventions

Calorie restriction via total food replacement BEHAVIORAL

Restricted foods designed by a clinical nutritionist that delivers to home for diabetic patients.

Low-calorie diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeouido St. Mary's Hospital: lead
• Abbott: collaborator

Study Sites (1)

Yeouido St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

• Hyuk-Sang Kwon

  Yeouido St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 6, 2023
• Study Start: June 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)