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Diamel in the Treatment of Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by:
Catalysis SL
ClinicalTrials.gov Identifier:
NCT01025115
First received: December 2, 2009
Last updated: March 30, 2010
Last verified: March 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Diamel in the Treatment of Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
  • Blood concentrations of insulin at months 0,3,6,9,12. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Blood concentrations of cholesterol at months 0,3,6,9,12. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Blood concentrations of HDL-cholesterol at months 0,3,6,9,12. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Blood concentrations of triglycerides at months 0,3,6,9,12. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Blood concentrations of creatinine at months 0,3,6,9,12. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Blood concentrations of uric acid at months 0,3,6,9,12. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood pressure at months 0,3,6,9,12. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • BMI index at months 0,3,6,9,12. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Waist-to-hip index at months 0,3,6,9,12. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eduardo Cabrera-Rode, National Institute of Endocrinology
ClinicalTrials.gov Identifier: NCT01025115     History of Changes
Other Study ID Numbers: CAT-0918-CU
Study First Received: December 2, 2009
Last Updated: March 30, 2010
Health Authority: Cuba: Institutional Review Board

Keywords provided by Catalysis SL:
Dietary supplement
Diamel
Metabolic Syndrome

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

ClinicalTrials.gov processed this record on May 23, 2013