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

This study has been completed.
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01071785
First received: June 6, 2008
Last updated: February 25, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Albuminuria
 Dietary Supplement: guar gum

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dietetic Intervention With Soluble Fiber in Type 2 Diabetes Mellitus (DM) Patients With Metabolic Syndrome (MS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • 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. [ Time Frame: 4 and 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes on serum fatty acids and serum cholesterol [ Time Frame: 4 and 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: June 2007
Study Completion Date: December 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: usual diet
no dietary or drug intervention. Patients followed their usual diet.
Experimental: guar gum
guar gum
 Dietary Supplement: guar gum
guar gum 10g/day for six weeks
Other Name: benefiber; guar gum group

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071785

Locations
Brazil
HCPA
Porto Alegre, RS, Brazil, 90630040
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Mirela J Azevedo, MD HCPA
Study Director: Jorge L Gross, MD HCPA
Principal Investigator: Valesca Dall'Alba, RD HCPA
  More Information

No publications provided

Responsible Party: Mirela jobim de Azevedo, Federal University of Rio GRAnde do sul
ClinicalTrials.gov Identifier: NCT01071785     History of Changes
Other Study ID Numbers: HCPA-06370
Study First Received: June 6, 2008
Last Updated: February 25, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
Metabolic Syndrome
diet
fiber
Serum lipids
Albuminuria

Additional relevant MeSH terms:
Albuminuria
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Proteinuria
Urination Disorders
Urologic Diseases
 Urological Manifestations
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on May 22, 2013