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Clinical Trials in China / NCT07103382
Recruiting Not applicable

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

NCT07103382 · tracked via the Priya Life Science China tracker
Sponsor
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)

Trial sites (1)

FacilityCityRegionStatus
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University Changsha Hunan Recruiting

More Second Xiangya Hospital of Central South University trials in China

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Official registry record

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.

View NCT07103382 on ClinicalTrials.gov ↗ ← All trials in China