Second Xiangya Hospital of Central South University
Phase
Not applicable
Started
2025-06-26
Last updated
2025-09-05
Condition(s) studied
Obesity
Investigational drug(s) / intervention(s)
AttapulgitePlacebo
Attapulgite: Participants were administered daily attapulgite (2.5 g) for a duration of 12 weeks.
Placebo: Participants were administered daily maltodextrin (2.5 g) for a duration of 12 weeks.
Study summary
To explore the safety and efficacy of attapulgite in the treatment of obese individuals or overweight/obese individuals with type 2 diabetes.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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
Primary outcome measure(s)
BMI (Body Mass Index) — "Baseline" "6 weeks" and "12 weeks" BMI used to assess body weight relative to height, the unit of BMI is kg/m² (kilograms per square meter).
Trial sites (1)
Facility
City
Region
Status
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha
Hunan
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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