Efficacy and Safety of Attapulgite in Patients With Obesity: An Exploratory Clinical Trial
Recruiting · NCT07103382 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Xiangya Hospital of Central South University
View the official record on ClinicalTrials.gov →Interventions studied
AttapulgitePlacebo
What this trial is about
To explore the safety and efficacy of attapulgite in the treatment of obese individuals or overweight/obese individuals with type 2 diabetes.
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- bese individuals:
- Aged 18-60 years, regardless of sex/gender
- BMI≥28.0kg/m2
- verweight 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 is running
1 location listed.
- Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University - Changsha, Hunan, China