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

NCT07753447

CompletedPhase 4

Sponsor: Yeouido St. Mary's Hospital

Conditions: Diabetes, Type 2, Obesity &Amp; Overweight

Interventions: Contrave ER, Low-calorie meal box

Countries: South Korea

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

Eligibility overview

Sex: ALL

Age: 19 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Seoul, South Korea