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

Launched by SECOND XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Aug 2, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether a substance called attapulgite is safe and helpful for people who are obese or overweight and also have type 2 diabetes. The goal is to see if attapulgite can support weight management and improve health in these groups. The study is not yet recruiting participants.

People who might join the study are adults between 19 and 60 years old who are either obese (with a body mass index, or BMI, of 28 or higher) or overweight/obese with type 2 diabetes (BMI of 24 or higher, along with certain blood sugar levels). Participants should have been on stable diabetes treatment for at least six months if they have diabetes. The trial has several important rules about who cannot join, including those with other types of diabetes, recent serious health problems, certain surgeries, digestive issues, or pregnancy. If eligible, participants can expect to be closely monitored for safety and how well attapulgite works during the study. This trial aims to better understand if attapulgite could be a useful option for managing obesity and diabetes.

Gender

ALL

Eligibility criteria

• 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