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

ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSecond Xiangya Hospital of Central South University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-60 years, regardless of sex/gender

BMI≥28.0kg/m2

Aged 18-60 years, regardless of sex/gender

BMI≥24.0kg/m2

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: AttapulgiteExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

BMI (Body Mass Index)

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

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

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"

Other outcomes

Sponsors and contacts

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