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Diamel in the Treatment of Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Phase 3

Locations

Cuba

Study Type

Interventional

Intervention

Diamel

Placebo

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Dietary supplement, Diamel, Metabolic Syndrome

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Institute of Endocrinology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Diamel

Placebo

Outcomes

Primary Outcome Measures

Blood concentrations of glucose at months 0,3,6,9,12.

Blood concentrations of insulin at months 0,3,6,9,12.

Blood concentrations of cholesterol at months 0,3,6,9,12.

Blood concentrations of HDL-cholesterol at months 0,3,6,9,12.

Blood concentrations of triglycerides at months 0,3,6,9,12.

Blood concentrations of creatinine at months 0,3,6,9,12.

Blood concentrations of uric acid at months 0,3,6,9,12.

Secondary Outcome Measures

Blood pressure at months 0,3,6,9,12.

BMI index at months 0,3,6,9,12.

Waist-to-hip index at months 0,3,6,9,12.

Full Information

NCT ID

NCT01025115

First Posted

December 2, 2009

Last Updated

March 30, 2010

Sponsor

Catalysis SL

1. Study Identification

Unique Protocol Identification Number

NCT01025115

Brief Title

Diamel in the Treatment of Metabolic Syndrome

Official Title

Efficacy of Diamel in the Treatment of Metabolic Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Catalysis SL

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

Dietary supplement, Diamel, Metabolic Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Diamel

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

Diamel

Intervention Description

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).

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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).

Primary Outcome Measure Information:

Title

Blood concentrations of glucose at months 0,3,6,9,12.

Time Frame

12 months

Title

Blood concentrations of insulin at months 0,3,6,9,12.

Time Frame

12 months

Title

Blood concentrations of cholesterol at months 0,3,6,9,12.

Time Frame

12 months

Title

Blood concentrations of HDL-cholesterol at months 0,3,6,9,12.

Time Frame

12 months

Title

Blood concentrations of triglycerides at months 0,3,6,9,12.

Time Frame

12 months

Title

Blood concentrations of creatinine at months 0,3,6,9,12.

Time Frame

12 months

Title

Blood concentrations of uric acid at months 0,3,6,9,12.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Blood pressure at months 0,3,6,9,12.

Time Frame

12 months

Title

BMI index at months 0,3,6,9,12.

Time Frame

12 months

Title

Waist-to-hip index at months 0,3,6,9,12.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eduardo Cabrera-Rode, PhD

Organizational Affiliation

National Institute of Endocrinology

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institute of Endocrinology

City

Havana City

State/Province

Havana

ZIP/Postal Code

10400

Country

Cuba

12. IPD Sharing Statement

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Diamel in the Treatment of Metabolic Syndrome

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