- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01025115
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
-
-
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
|
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
|
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
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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-
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