Attapulgite for weight management in adults with obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, placebo-controlled, interventional trial testing oral attapulgite versus placebo in adults with obesity or overweight adults who have type 2 diabetes. Eligible participants are adults aged 18–60 who meet specified BMI thresholds and, for the diabetes group, defined HbA1c or fasting glucose ranges with stable diabetes therapy. The trial focuses on safety and efficacy outcomes related to weight and glycemic measures and will monitor adverse events. The trial is conducted at the Institute of Metabolism and Endocrinology, Second Xiangya Hospital in Changsha, Hunan, China.

Why it matters

Who can join: the full rules

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

Where it's running

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.