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The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Metabolic Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Diamel |
|
| B | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diamel | Dietary Supplement | Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 months, together with the standard treatment for metabolic syndrome consisting in appropriate diet according to patient's weight and physical activity, and appropriate hypertensive drugs (generally ACE inhibitors) for hypertension. Patient´s were also verbally encouraged to increase physical activity (to walk for 30-45 minutes a day 3-4 days a week). |
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentrations of glucose at months 0,3,6,9,12. | 12 months | |
| Blood concentrations of insulin at months 0,3,6,9,12. | 12 months | |
| Blood concentrations of cholesterol at months 0,3,6,9,12. | 12 months | |
| Blood concentrations of HDL-cholesterol at months 0,3,6,9,12. | 12 months | |
| Blood concentrations of triglycerides at months 0,3,6,9,12. | 12 months | |
| Blood concentrations of creatinine at months 0,3,6,9,12. | 12 months | |
| Blood concentrations of uric acid at months 0,3,6,9,12. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure at months 0,3,6,9,12. | 12 months | |
| BMI index at months 0,3,6,9,12. | 12 months | |
| Waist-to-hip index at months 0,3,6,9,12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Cabrera-Rode, PhD | National Institute of Endocrinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Endocrinology | Havana | La Habana | 10400 | Cuba |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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|
| Placebo | Dietary Supplement | Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 months, together with the standard treatment for metabolic syndrome consisting in appropriate diet according to patient's weight and physical activity, and appropriate hypertensive drugs (generally ACE inhibitors) for hypertension. Patient´s were also verbally encouraged to increase physical activity (to walk for 30-45 minutes a day 3-4 days a week). |
|
| 12 months |
| D009750 |
| Nutritional and Metabolic Diseases |