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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attapulgite | Experimental | Attapulgite capsules (0.4-0.5 g) were administered at a dose of 3 capsules twice daily for 12 weeks. |
|
| Placebo | Placebo Comparator | Maltodextrin capsules (0.4-0.5 g) were administered at a dose of 3 capsules twice daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attapulgite | Dietary Supplement | Participants were administered daily attapulgite (2.5 g) for a duration of 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| BMI (Body Mass Index) | BMI used to assess body weight relative to height, the unit of BMI is kg/m² (kilograms per square meter). | "Baseline" "6 weeks" and "12 weeks" |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | "Baseline" "6 weeks" and "12 weeks" | |
| Waist circumference | "Baseline" "6 weeks" and "12 weeks" | |
| Hip circumference |
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Inclusion Criteria:
Obese individuals:
Overweight or obese individuals with type 2 diabetes:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University | Recruiting | Changsha | Hunan | 410011 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C026325 | attapulgite |
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| Placebo | Dietary Supplement | Participants were administered daily maltodextrin (2.5 g) for a duration of 12 weeks. |
|
| "Baseline" "6 weeks" and "12 weeks" |
| Waist-to-hip ratio | "Baseline" "6 weeks" and "12 weeks" |
| Human body fat percentage | It measured via Lunar iDXA equipment | "Baseline" and "12 weeks" |
| Human basal metabolic rate | It measured via Lunar iDXA equipment, including basal metabolic rate, body fat percentage, visceral fat area, subcutaneous fat area, etc.) | "Baseline" and "12 weeks" |
| Visceral fat mass | It measured via iDXA equipment | "Baseline" and "12 weeks" |
| Subcutaneous fat area | It measured via iDXA equipment | "Baseline" and "12 weeks" |
| 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 | including fecal intestinal flora metagenome | "Baseline" and "12 weeks" |
| Gut metabolites | 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. | "Baseline" and "12 weeks" |
| Serum metabolites | 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. | "Baseline" and "12 weeks" |
| Fasting serum C peptide levels | "Baseline" "6 weeks" and "12 weeks" |
| Fasting serum insulin levels | "Baseline" "6 weeks" and "12 weeks" |
| Fasting blood glucose | It applies to individuals with overweight or obese type 2 diabetes | "Baseline" "6 weeks" "12 weeks" |
| Glycated albumin | It applies to individuals with overweight or obese type 2 diabetes | "Baseline" "6 weeks" and "12 weeks" |
| Glycated haemoglobin (HbA1c) | It applies to individuals with overweight or obese type 2 diabetes | "Baseline" "6 weeks" and "12 weeks" |
| 2-hour serum C peptide levels | "Baseline" and "12 weeks" |
| 2-hour serum insulin levels | "Baseline" and "12 weeks" |
| 2-hour blood glucose levels | "Baseline" and "12 weeks" |
| HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) | "Baseline" "6 weeks" and "12 weeks" |
| Inflammation markers | CRP, IgG, IgA, IgM, IgE | "Baseline" "6 weeks" and "12 weeks" |
| Hepatic function | including alanine aminotransferase and aspartate aminotransferase | "Baseline" "6 weeks" and "12 weeks" |
| 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 | Safety outcomes | 12 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |