Efficacy and Safety of Attapulgite in Patients With Obesity: An Exploratory Clinical Trial
NCT ID: NCT07103382
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-06-26
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Attapulgite
Attapulgite capsules (0.4-0.5 g) were administered at a dose of 3 capsules twice daily for 12 weeks.
Attapulgite
Participants were administered daily attapulgite (2.5 g) for a duration of 12 weeks.
Placebo
Maltodextrin capsules (0.4-0.5 g) were administered at a dose of 3 capsules twice daily for 12 weeks.
Placebo
Participants were administered daily maltodextrin (2.5 g) for a duration of 12 weeks.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Second Xiangya Hospital of Central South University
OTHER
Responsible Party
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Yang Xiao
Associate Professor, Department of Metabolism and Endocrinology, Institute of Metabolism and Endocrinology, National Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital, Central South University
Locations
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Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, Hunan, China
Countries
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Facility Contacts
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Other Identifiers
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2025 Attapulgite
Identifier Type: -
Identifier Source: org_study_id
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