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NCT Number: NCT07103382

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

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Changsha, Hunan, 410011, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Attapulgite

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. BMI (Body Mass Index)

    Time frame: "Baseline" "6 weeks" and "12 weeks"

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

Secondary outcomes

  1. Weight

    Time frame: "Baseline" "6 weeks" and "12 weeks"

  2. Waist circumference

    Time frame: "Baseline" "6 weeks" and "12 weeks"

  3. Hip circumference

    Time frame: "Baseline" "6 weeks" and "12 weeks"

  4. Waist-to-hip ratio

    Time frame: "Baseline" "6 weeks" and "12 weeks"

  5. Human body fat percentage

    Time frame: "Baseline" and "12 weeks"

    It measured via Lunar iDXA equipment

  6. Human basal metabolic rate

    Time frame: "Baseline" and "12 weeks"

    It measured via Lunar iDXA equipment, including basal metabolic rate, body fat percentage, visceral fat area, subcutaneous fat area, etc.)

  7. Visceral fat mass

    Time frame: "Baseline" and "12 weeks"

    It measured via iDXA equipment

  8. Subcutaneous fat area

    Time frame: "Baseline" and "12 weeks"

    It measured via iDXA equipment

  9. Serum triglycerides

    Time frame: "Baseline" "6 weeks" and "12 weeks"

  10. Serum total cholesterol

    Time frame: "Baseline" "6 weeks" and "12 weeks"

  11. Serum LDL-c

    Time frame: "Baseline" "6 weeks" and "12 weeks"

  12. Serum HDL-c

    Time frame: "Baseline" "6 weeks" and "12 weeks"

  13. Gut microbiome

    Time frame: "Baseline" and "12 weeks"

    including fecal intestinal flora metagenome

  14. Gut metabolites

    Time frame: "Baseline" and "12 weeks"

    In aid of LC/MS and GC/MS technique, etc, we will measure the metabolomics molecular profile in fecal samples before and after treatment.The metabolomics measurement will help to detect the profile of all kinds of lipids species and amino acid species, etc.

  15. Serum metabolites

    Time frame: "Baseline" and "12 weeks"

    In aid of LC/MS and GC/MS technique, etc, we will measure the metabolomics molecular profile in blood samples before and after treatment.The metabolomics measurement will help to detect the profile of all kinds of lipids species and amino acid species, etc.

  16. Fasting serum C peptide levels

    Time frame: "Baseline" "6 weeks" and "12 weeks"

  17. Fasting serum insulin levels

    Time frame: "Baseline" "6 weeks" and "12 weeks"

  18. Fasting blood glucose

    Time frame: "Baseline" "6 weeks" "12 weeks"

    It applies to individuals with overweight or obese type 2 diabetes

  19. Glycated albumin

    Time frame: "Baseline" "6 weeks" and "12 weeks"

    It applies to individuals with overweight or obese type 2 diabetes

  20. Glycated haemoglobin (HbA1c)

    Time frame: "Baseline" "6 weeks" and "12 weeks"

    It applies to individuals with overweight or obese type 2 diabetes

  21. 2-hour serum C peptide levels

    Time frame: "Baseline" and "12 weeks"

  22. 2-hour serum insulin levels

    Time frame: "Baseline" and "12 weeks"

  23. 2-hour blood glucose levels

    Time frame: "Baseline" and "12 weeks"

  24. HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)

    Time frame: "Baseline" "6 weeks" and "12 weeks"

  25. Inflammation markers

    Time frame: "Baseline" "6 weeks" and "12 weeks"

    CRP, IgG, IgA, IgM, IgE

  26. Hepatic function

    Time frame: "Baseline" "6 weeks" and "12 weeks"

    including alanine aminotransferase and aspartate aminotransferase

  27. Serum urea nitrogen

    Time frame: "Baseline" "6 weeks" and "12 weeks"

  28. Serum creatinine

    Time frame: "Baseline" "6 weeks" and "12 weeks"

  29. Serum urinary acid

    Time frame: "Baseline" "6 weeks" and "12 weeks"

  30. Adverse events

    Time frame: 12 weeks

    Safety outcomes

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Second Xiangya Hospital of Central South University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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