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Diamel in the Treatment of Metabolic Syndrome

NCT ID: NCT01025115

Last Updated: 2010-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolic Syndrome

Keywords

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Dietary supplement Diamel Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Diamel

Group Type EXPERIMENTAL

Diamel

Intervention Type DIETARY_SUPPLEMENT

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).

B

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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).

Interventions

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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).

Intervention Type 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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catalysis SL

INDUSTRY

Sponsor Role lead

Responsible Party

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National Institute of Endocrinology

Principal Investigators

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Eduardo Cabrera-Rode, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Endocrinology

Locations

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National Institute of Endocrinology

Havana, La Habana, Cuba

Site Status

Countries

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Cuba

Other Identifiers

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CAT-0918-CU

Identifier Type: -

Identifier Source: org_study_id