Diamel in the Treatment of Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Efficacy of Diamel in the Treatment of Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025115
• Other study ID #: CAT-0918-CU
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2009
• Last updated: March 30, 2010
• Start date: March 2009
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Diamel
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).
• Placebo
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).

Locations

Country	Name	City	State
Cuba	National Institute of Endocrinology	Havana City	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood concentrations of glucose at months 0,3,6,9,12.		12 months	Yes
Primary	Blood concentrations of insulin at months 0,3,6,9,12.		12 months	Yes
Primary	Blood concentrations of cholesterol at months 0,3,6,9,12.		12 months	Yes
Primary	Blood concentrations of HDL-cholesterol at months 0,3,6,9,12.		12 months	Yes
Primary	Blood concentrations of triglycerides at months 0,3,6,9,12.		12 months	Yes
Primary	Blood concentrations of creatinine at months 0,3,6,9,12.		12 months	Yes
Primary	Blood concentrations of uric acid at months 0,3,6,9,12.		12 months	Yes
Secondary	Blood pressure at months 0,3,6,9,12.		12 months	No
Secondary	BMI index at months 0,3,6,9,12.		12 months	No
Secondary	Waist-to-hip index at months 0,3,6,9,12.		12 months	No