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

Second Xiangya Hospital of Central South University40 enrolled

Overview

To explore the safety and efficacy of attapulgite in the treatment of obese individuals or overweight/obese individuals with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Obesity

Interventions

AttapulgiteDIETARY_SUPPLEMENT

Participants were administered daily attapulgite (2.5 g) for a duration of 12 weeks.

PlaceboDIETARY_SUPPLEMENT

Participants were administered daily maltodextrin (2.5 g) for a duration of 12 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

Changsha, Hunan, China

RECRUITING

Outcomes

Primary Outcomes

BMI (Body Mass Index)

BMI used to assess body weight relative to height, the unit of BMI is kg/m² (kilograms per square meter).