NCT01025115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 31, 2010

Status Verified

March 1, 2010

Enrollment Period

1 year

First QC Date

December 2, 2009

Last Update Submit

March 30, 2010

Conditions

Metabolic Syndrome

Keywords

Dietary supplementDiamelMetabolic Syndrome

Outcome Measures

Primary Outcomes (7)

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

    12 months

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

    12 months

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

    12 months

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

    12 months

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

    12 months

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

    12 months

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

    12 months

Secondary Outcomes (3)

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

    12 months

  • BMI index at months 0,3,6,9,12.

    12 months

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

    12 months

Study Arms (2)

A

EXPERIMENTAL

Diamel

Dietary Supplement: Diamel

B

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

DiamelDIETARY_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).

A
PlaceboDIETARY_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).

B

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metabolic syndrome diagnosis according to WHO definition, with or without glucose intolerance.
  • Signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Endocrinology

Havana, La Habana, 10400, Cuba

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Eduardo Cabrera-Rode, PhD

    National Institute of Endocrinology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 31, 2010

Record last verified: 2010-03

Locations

CU(1)