A Phase 3 interventional study of Diamel and Placebo in Metabolic Syndrome, sponsored by Catalysis SL. Completed at 1 site in Cuba. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-03-31.
Sponsored by Catalysis SL · Phase 3, Interventional, and Treatment
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.
2,011 studies on the registry are indexed under Metabolic Syndrome; 334 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 1,494 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Catalysis SL is the lead sponsor of 53 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Diamel
Dietary Supplement: Diamel
Placebo
Dietary Supplement: Placebo
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).
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).
Blood concentrations of glucose at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of insulin at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of cholesterol at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of HDL-cholesterol at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of triglycerides at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of creatinine at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of uric acid at months 0,3,6,9,12.
Time frame: 12 months
Blood pressure at months 0,3,6,9,12.
Time frame: 12 months
BMI index at months 0,3,6,9,12.
Time frame: 12 months
Waist-to-hip index at months 0,3,6,9,12.
Time frame: 12 months
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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