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Completed

NCT Number: NCT01025115

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Institute of Endocrinology

Havana, La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diamel

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).

Placebo

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).

Primary outcomes

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

Efficacy of Diamel in the Treatment of Metabolic Syndrome

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 3, 2009
Registry last updated
Mar 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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