Metabolic Syndrome
Conditions
Keywords
Dietary supplement, Diamel, Metabolic Syndrome
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTDiamel
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).
DIETARY_SUPPLEMENTPlacebo
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).
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentrations of uric acid 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 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 glucose at months 0,3,6,9,12. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| BMI index at months 0,3,6,9,12. | 12 months |
| Waist-to-hip index at months 0,3,6,9,12. | 12 months |
| Blood pressure at months 0,3,6,9,12. | 12 months |
Countries
Cuba
Outcome results
None listed