Dietetic Intervention With Soluble Fiber in Type 2 Diabetes Mellitus (DM) Patients With Metabolic Syndrome (MS)

NCT ID: NCT01071785

Last Updated: 2010-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-12-31

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.

Detailed Description

The aim of this study was to evaluate the effect of soluble fiber (guar gum) on the MS components (International Diabetes Federation-2005 and WHO): blood pressure, plasma glucose, triglycerides, HDL, central obesity (waist, BMI),and albuminuria. Secondary objectives are: effect of guar gum on serum fatty acids, , PCR, endothelin 1, and fibrinogen. Primary outcomes were alterations on MS components.

Forty-four type 2 diabetic outpatients were included in a randomized clinical trial: treatment 1- guar gum (10g/day) + usual diet; treatment 2- usual diet. The duration of each treatment was six weeks. Three days weight diet records with concurrent 24h urinary collections (protein intake estimative), clinical and laboratory evaluation were performed at baseline and after 4 and 6 weeks. Serum fatty acids were measured in total triglycerides fractions by gas chromatography.

Conditions

Metabolic Syndrome; Albuminuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

usual diet

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

guar gum

guar gum

Group Type: EXPERIMENTAL

guar gum

Intervention Type: DIETARY_SUPPLEMENT

guar gum 10g/day for six weeks

Interventions

guar gum

guar gum 10g/day for six weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

benefiber; guar gum group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Federal University of Rio GRAnde do sul

Principal Investigators

Mirela J Azevedo, MD

Role: PRINCIPAL_INVESTIGATOR

HCPA

Jorge L Gross, MD

Role: STUDY_DIRECTOR

HCPA

Valesca Dall'Alba, RD

Role: PRINCIPAL_INVESTIGATOR

HCPA

Locations

HCPA

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

HCPA-06370

Identifier Type: -

Identifier Source: org_study_id