Obesity
Conditions
Keywords
attapulgite, obesity, placebo-controlled study, randomized controlled trial
Brief summary
To explore the safety and efficacy of attapulgite in the treatment of obese individuals or overweight/obese individuals with type 2 diabetes.
Interventions
DIETARY_SUPPLEMENTAttapulgite
Participants were administered daily attapulgite (2.5 g) for a duration of 12 weeks.
DIETARY_SUPPLEMENTPlacebo
Participants were administered daily maltodextrin (2.5 g) for a duration of 12 weeks.
Sponsors
Second Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI (Body Mass Index) | 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
| Measure | Time frame | Description |
|---|---|---|
| HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) | Baseline 6 weeks and 12 weeks | — |
| Weight | Baseline 6 weeks and 12 weeks | — |
| Waist circumference | Baseline 6 weeks and 12 weeks | — |
| Hip circumference | Baseline 6 weeks and 12 weeks | — |
| Waist-to-hip ratio | Baseline 6 weeks and 12 weeks | — |
| Human body fat percentage | Baseline and 12 weeks | It measured via Lunar iDXA equipment |
| Human basal metabolic rate | Baseline and 12 weeks | It measured via Lunar iDXA equipment, including basal metabolic rate, body fat percentage, visceral fat area, subcutaneous fat area, etc.) |
| Visceral fat mass | Baseline and 12 weeks | It measured via iDXA equipment |
| Subcutaneous fat area | Baseline and 12 weeks | It measured via iDXA equipment |
| Serum triglycerides | Baseline 6 weeks and 12 weeks | — |
| Serum total cholesterol | Baseline 6 weeks and 12 weeks | — |
| Serum LDL-c | Baseline 6 weeks and 12 weeks | — |
| Serum HDL-c | Baseline 6 weeks and 12 weeks | — |
| Gut microbiome | Baseline and 12 weeks | including fecal intestinal flora metagenome |
| 2-hour blood glucose levels | Baseline and 12 weeks | — |
| Serum metabolites | 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. |
| Fasting serum C peptide levels | Baseline 6 weeks and 12 weeks | — |
| Fasting serum insulin levels | Baseline 6 weeks and 12 weeks | — |
| Fasting blood glucose | Baseline 6 weeks 12 weeks | It applies to individuals with overweight or obese type 2 diabetes |
| Glycated albumin | Baseline 6 weeks and 12 weeks | It applies to individuals with overweight or obese type 2 diabetes |
| Glycated haemoglobin (HbA1c) | Baseline 6 weeks and 12 weeks | It applies to individuals with overweight or obese type 2 diabetes |
| 2-hour serum C peptide levels | Baseline and 12 weeks | — |
| 2-hour serum insulin levels | Baseline and 12 weeks | — |
| Inflammation markers | Baseline 6 weeks and 12 weeks | CRP, IgG, IgA, IgM, IgE |
| Hepatic function | Baseline 6 weeks and 12 weeks | including alanine aminotransferase and aspartate aminotransferase |
| Serum urea nitrogen | Baseline 6 weeks and 12 weeks | — |
| Serum creatinine | Baseline 6 weeks and 12 weeks | — |
| Serum urinary acid | Baseline 6 weeks and 12 weeks | — |
| Adverse events | 12 weeks | Safety outcomes |
| Gut metabolites | 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. |
Countries
China
Outcome results
None listed