We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diamel in the Treatment of Metabolic Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01025115
First Posted: December 3, 2009
Last Update Posted: March 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Catalysis SL
  Purpose
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.

Condition Intervention Phase
Metabolic Syndrome Dietary Supplement: Diamel Dietary Supplement: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Diamel in the Treatment of Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: March 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Diamel
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 Comparator: B
Placebo
Dietary Supplement: 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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01025115


Locations
Cuba
National Institute of Endocrinology
Havana City, Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Eduardo Cabrera-Rode, PhD National Institute of Endocrinology
  More Information

Responsible Party: Eduardo Cabrera-Rode, National Institute of Endocrinology
ClinicalTrials.gov Identifier: NCT01025115     History of Changes
Other Study ID Numbers: CAT-0918-CU
First Submitted: December 2, 2009
First Posted: December 3, 2009
Last Update Posted: March 31, 2010
Last Verified: March 2010

Keywords provided by Catalysis SL:
Dietary supplement
Diamel
Metabolic Syndrome

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases