NCT01071785

Brief Summary

Metabolic Syndrome (MS) is an clinical condition with high cardiovascular risk. More than 80% of DM patients had MS. Dietary factors can be associated to both, DM and MS. Therefore the aim of this study is to evaluate the effects of add soluble fiber (goma-guar) in the usual diet of type 2 DM with MS and compare this intervention with an usual diet without this supplement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 6, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
Last Updated

March 1, 2010

Status Verified

February 1, 2010

Enrollment Period

1.3 years

First QC Date

June 6, 2008

Last Update Submit

February 25, 2010

Conditions

Metabolic SyndromeAlbuminuria

Keywords

Metabolic SyndromedietfiberSerum lipidsAlbuminuria

Outcome Measures

Primary Outcomes (1)

  • Changes on the components of metabolic syndrome (according to IDF and WHO criteria): blood pressure, waist, body mass index (BMI), triglycerides, high-density lipoprotein (HDL) cholesterol, glucose values (HBA1c) and urinary albumin excretion.

    4 and 6 weeks

Secondary Outcomes (1)

  • changes on serum fatty acids and serum cholesterol

    4 and 6 weeks

Study Arms (2)

usual diet

NO INTERVENTION

no dietary or drug intervention. Patients followed their usual diet.

guar gum

EXPERIMENTAL

guar gum

Dietary Supplement: guar gum

Interventions

guar gumDIETARY_SUPPLEMENT

guar gum 10g/day for six weeks

Also known as: benefiber; guar gum group
guar gum

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 2 diabetes
  • Using metformin and/or Insulin

You may not qualify if:

  • serum triglycerides \> 400 mg/dl
  • serum creatinine \> 2 mg/dl
  • gastrointestinal malabsorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HCPA

Porto Alegre, Rio Grande do Sul, 90630040, Brazil

Location

MeSH Terms

Conditions

Metabolic SyndromeAlbuminuria

Interventions

guar gum

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesProteinuriaUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mirela J Azevedo, MD

    HCPA

    PRINCIPAL INVESTIGATOR

  • Jorge L Gross, MD

    HCPA

    STUDY DIRECTOR

  • Valesca Dall'Alba, RD

    HCPA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2008

First Posted

February 19, 2010

Study Start

June 1, 2007

Primary Completion

September 1, 2008

Study Completion

December 1, 2009

Last Updated

March 1, 2010

Record last verified: 2010-02

Locations

BR(1)