Diamel in the Treatment of Metabolic Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Diamel in the Treatment of Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Diamel
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metabolic syndrome diagnosis according to WHO definition, with or without glucose intolerance. Signed informed consent Exclusion Criteria: Type 1 diabetes Type 2 diabetes treated with oral hypoglycemic drugs and/or insulin Other diseases associated with insulin resistance (eg. Acromegalia, endogenous hypercortisolism, etc) Neuropathies or hepatic conditions diagnosed biochemically or by clinical exam. Mild or severe heart conditions (eg. heart failure, ischemic cardiopathy) Sepsis or any other condition that could potentially interfere with treatment Any other treatment that could potentially interfere with treatment Pregnancy

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Diamel | Dietary Supplement: Diamel<br>* 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).<br>|
| Placebo Comparator: B<br>Placebo | Dietary Supplement: Placebo<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary supplement, Diamel, Metabolic Syndrome