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

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Albuminuria
• Interventions: Dietary Supplement: guar gum

• Registration Number: NCT01071785
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-06-06
• Primary Completion: 2008-09
• Study Completion: 2009-12
• Status Verified: 2010-02
• Study First Submitted QC: 2010-02-18
• Study First Posted: 2010-02-19
• Last Update Submitted: 2010-02-25
• Last Update Posted: 2010-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
guar gum	guar gum	guar gum

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
changes on serum fatty acids and serum cholesterol	4 and 6 weeks

Trial Locations

Locations (1)

HCPA; 🇧🇷 Porto Alegre, RS, Brazil