Diamel in the Treatment of Metabolic Syndrome

March 30, 2010 updated by: Catalysis SL

Efficacy of Diamel in the Treatment of Metabolic Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
    • Havana
      • Havana City, Havana, Cuba, 10400
        • National Institute of Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood concentrations of glucose at months 0,3,6,9,12.
Time Frame: 12 months
12 months
Blood concentrations of insulin at months 0,3,6,9,12.
Time Frame: 12 months
12 months
Blood concentrations of cholesterol at months 0,3,6,9,12.
Time Frame: 12 months
12 months
Blood concentrations of HDL-cholesterol at months 0,3,6,9,12.
Time Frame: 12 months
12 months
Blood concentrations of triglycerides at months 0,3,6,9,12.
Time Frame: 12 months
12 months
Blood concentrations of creatinine at months 0,3,6,9,12.
Time Frame: 12 months
12 months
Blood concentrations of uric acid at months 0,3,6,9,12.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure at months 0,3,6,9,12.
Time Frame: 12 months
12 months
BMI index at months 0,3,6,9,12.
Time Frame: 12 months
12 months
Waist-to-hip index at months 0,3,6,9,12.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Investigators

  • Principal Investigator: Eduardo Cabrera-Rode, PhD, National Institute of Endocrinology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 2, 2009

First Submitted That Met QC Criteria

December 2, 2009

First Posted (Estimate)

December 3, 2009

Study Record Updates

Last Update Posted (Estimate)

March 31, 2010

Last Update Submitted That Met QC Criteria

March 30, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT-0918-CU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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