Attapulgite for weight management in adults with obesity
Efficacy and Safety of Attapulgite in Patients With Obesity: An Exploratory Clinical Trial
This study will test whether taking attapulgite can safely help adults with obesity, including overweight adults with type 2 diabetes, lose weight or improve blood sugar control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Second Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT07103382 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–60 with BMI ≥28 kg/m2, or adults 18–60 with BMI ≥24 kg/m2 who have type 2 diabetes with HbA1c 7.0–10.0% (or fasting glucose 7.0–13.3 mmol/L) on stable diabetes treatment, are the intended participants.
Not a fit: People with type 1 or secondary forms of diabetes, recent severe diabetic complications, uncontrolled hypertension or severe organ dysfunction, endocrine causes of obesity, recent large weight fluctuations, or current use of weight‑affecting products are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, attapulgite could offer a well-tolerated oral option to help people with obesity lose weight and improve blood sugar control.
How similar studies have performed: Using attapulgite for weight loss is relatively novel and clinical evidence supporting its effectiveness for obesity is limited, so this approach is exploratory.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Changsha, Hunan
- Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University — Changsha, Hunan, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.