Efficacy and Safety of Attapulgite in Patients With Obesity: An Exploratory Clinical Trial

Central South University

Status

Enrolling

Conditions

Obesity

Treatments

Dietary Supplement: Attapulgite

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT07103382

2025 Attapulgite

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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