Overview

To explore the safety and efficacy of attapulgite in the treatment of obese individuals or overweight/obese individuals with type 2 diabetes.

Eligibility

Inclusion Criteria:

Obese individuals:

• Aged 18-60 years, regardless of sex/gender
• BMI≥28.0kg/m2

Overweight or obese individuals with type 2 diabetes:

• Aged 18-60 years, regardless of sex/gender
• BMI≥24.0kg/m2
• HbA1c ≥7.0% and ≤10.0% or the fasting blood glucose ≥7.0 mmol/l and ≤ 13.3 mmol/l at screening
• Stable diabetes treatment for at least 6 months or more

Exclusion Criteria:

• Type 1 diabetes, monogenic diabetes, or diabetes due to pancreatic injury or other secondary diabetes
• Severe diabetic complications within three months before the study initiation, including severe hypoglycemia, diabetic ketoacidosis, or infections
• Use of weight-affecting products within the past three months or planned use during the study
• Weight fluctuation >5 kg or >10% within the past three months
• Obesity or overweight due to endocrine disorders (such as thyroid dysfunction or Cushing's syndrome)
• Uncontrolled hypertension, severe cardiac/hepatic/renal dysfunction
• History of gastrointestinal surgery (such as cholecystectomy) within the past year or non-gastrointestinal surgery within six months, or prior bariatric surgery
• Chronic gastrointestinal disorders (such as recurrent constipation, celiac disease, or food intolerances) or any condition impairing digestion/absorption function
• History of malignant tumors within five years, regardless of whether there is recurrence or metastasis and severe immune dysfunction (such as malignant tumors, HIV/AIDS, immunodeficiency diseases)
• Use of probiotics, prebiotics, or antibiotics within three months prior to enrollment, or alcohol abuse; Consumption of yogurt within two weeks before the study or during the trial period; History of psychiatric or infectious diseases
• Pregnancy, lactation, or plans for pregnancy during the study
• Participation in other clinical trials within the past three months
• Any condition that in the judgement of the investigator precludes participation