Diamel in the Treatment of Metabolic Syndrome

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Diamel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01025115

CAT-0918-CU

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Diamel

Treatment:

Dietary Supplement: Diamel

B

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo