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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:
ClinicalTrials.gov Identifier:
NCT01071785
First Posted: February 19, 2010
Last Update Posted: March 1, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital de Clinicas de Porto Alegre
  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: None (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:


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 ]

Secondary Outcome Measures:
  • changes on serum fatty acids and serum cholesterol [ Time Frame: 4 and 6 weeks ]

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

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 6, 2008
First Posted: February 19, 2010
Last Update Posted: March 1, 2010
Last Verified: February 2010

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

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